Master Plan
Laboratory Compliance
January 2014
This is an example of a Master Plan. It is a proposal and starting point only. The type and extent of documentation depends on the process environment. The proposed documentation should be adapted accordingly and should be based on individual risk assessments. There is no guarantee that this document will pass a regulatory inspection.
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Master Plan )ocument *umber+ M-## er. -.xx Laboratory Compliance
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Master Plan )ocument *umber+ M-## er. -.xx Laboratory Compliance
Page ' of (#
Company Name:
Controls:
!uperse rseded )o )ocumen ment
*%/, ne new
0eason for 0evision
*%/
1ffective )ate
2anuary -, '$-3
Sinatures:
/uthor
/pprover /pprover
0eviewe ewer
I indicate indicate that I have authored authored or or updated updated this Master Master Plan according to applicable business re4uirements and our company standards. *ame+
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!ign !ignatu ature+ re+
55555 55555555 55555 5555 5555 55555 555555 55555 55555 555555 55555 5555 55
)ate+
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I indicate indicate that I have reviewed reviewed this Master Plan, Plan, and find it meets all applicable business re4uirements and that it reflects the procedure described. I approve it for use. *ame+
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!ign !ignatu ature+ re+
55555 55555555 55555 5555 5555 55555 555555 55555 55555 555555 55555 5555 55
)ate+
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I in indica icate that hat I have re review iewed th this Maste ster Pl Plan an and fin find d th that it meets all applicable 4uality re4uirements and company standards. I approve it for use. *ame+
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Master Plan )ocument *umber+ M-## er. -.xx Laboratory Compliance
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!able of Contents 1. "ntro#uction$ Scope an# %b&ecti'es of of t(is )ocument.................... )ocument............................. .................. ..............* .....*
-.-Introduction..............................................................................................................6 -.'The -.' The Laboratory...... Laboratory............... ................. ................. .................. .................. .................. ................. ................. .....................................6 ............................6 -.#!cope -.# !cope of the Master Plan.............. Plan....................... .................. ................. ................. .................. .................. ..............................6 .....................6 -.3"b7ectiv -.3 "b7ectives es of the Master Plan.............. Plan....................... .................. .................. ................. ........................................6 ................................6 2. Policy................. Policy......................... ................. .................. .................. .................. ................. ................. .................. .................. .................. .................. ...................+ ..........+ ,. Structure of -MS )ocumentation........... )ocumentation................... ................. .................. .................. .................. ............................... ......................
#.-)ocumentation 8ierarchy........................................................................................9 #.'Laboratory :ompliance and :orporate Master Plans.............................................; 3.2.1 Risk Management Master Plan (19.1.1).......................................... ................ ........ ................ ........ 9 3.2.2 Equipment Qualification Master Plan (19.1.2)............................ ................. ........ ................. ........ 10 3.2.3 omputer !"stem #ali$ation #ali$ation Master Plan (19.1.3)................................................10 3.2.% &et'ork Qualification Master Plan (19.1.%)..................................... ................ ........ ............ ....10 10 3.2. 21 R Part 11 ompliance Master Plan (19.1.)....................... ................. ......... ............... ....... 10 3.2.* +raining +raining Master Plan (19.1.*)...................................................... ................ ........ ................ .........10 .10 3.2., ali-ration an$ Preentie Maintenance Master Plan (19.1.,)............................10 #.#Processes..............................................................................................................-#.3Procedu #.3 Procedures res and
3.-Management..........................................................................................................-# 3.'uality /ssurance..................................................................................................-# 3.#)epartme 3.# )epartment nt Manager and !upervisors....... !upervisors................ .................. ................. .................................. ................................-3 ......-3 3.3/naly 3.3 /nalysts........ sts................. .................. .................. .................. ................. ................. .................. .................. .................. ..................................-( .........................-( 3.(!afety "fficer.........................................................................................................-( . acilities an# 3n'ironmental Con#itions.................. Con#itions........................... .................. .................. ...........................1 ..................1 *. )ocument Control.................. Control.......................... ................. .................. .................. .................. ................. ................. .................. ......................1+ .............1+ +. "nternal u#its.................... u#its............................. ................. ................. .................. .................. .................. .................. ......................... .........................1 .........1 www.labcompliance.com www.labcompliance.com (Replace with your your company’s name) !E
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Master Plan Page 3 of (# )ocument *umber+ M-## er. -.xx Laboratory Compliance . Manaement e'iews......................... e'iews.................................. .................. .................. ................. ................. .................. .................. .................15 ........15 5. Staffin an# People -ualification................. -ualification.......................... .................. ................. ........................................20 ................................20
;.-Procedu ;.- Procedure...... re............... .................. .................. .................. ................. ................. .................. .................. .................. .................................'$ ........................'$ ;.'Training :ourses and Tools for Pre or !elf!tudy................................................';.#/ssessment Tools..................................................................................................'10. Selection an# 6ali#ation of nalytical Met(o#s an# Proce#ures........................22 Proce#ures........................22
-$.-
Method !election........ !election................. .................. .................. ................. ................. .................. .........................................'' ................................''
-$.'
alidation alidation of Methods )eveloped )eveloped by The Laboratory......... Laboratory.................. .............................'' ....................''
-$.#
erification erification of !tandard !tandard Methods............ Methods..................... .................. .................. ................. ................. ......................'# .............'#
-$.3
Method 0evalidation.... 0evalidation............. .................. .................. .................. ................. ................. ........................................'# ...............................'#
-$.(
=sing /lternative /lternative Methods.......... Methods................... .................. .................. .................. ................. .................................'# .........................'#
-$.6
=sing !oftware !oftware for /utomated /utomated Method alidation.... alidation............. .......................................'3 ..............................'3
11. 37uipment an# Computers................... Computers............................ .................. ................. ................. .................. .................. .......................24 ..............24
--.--.-
14uipment 14uipment Identification...... Identification.............. ................. .................. .................. .................. ................. ................. .................. ................'3 .......'3
--.' --.'
14uipment 14uipment Logs.............. Logs....................... ................. ................. .................. .................. .................. .....................................'( ............................'(
--.# --.#
ualification ualification of 14uipment 14uipment 8ardware......... 8ardware.................. .................. .................. ...................................'( ..........................'(
--.3 --.3
"ffthe!helf "ffthe!helf :omputer :omputer !ystem alidation.... alidation............. .................. ................. ................................'6 ........................'6
--.( --.(
alidation alidation of !oftware !oftware )eveloped )eveloped In8ouse........... In8ouse.................... ................. ................................'> ........................'>
--.6 --.6
"peration........ "peration................ ................. .................. .................. .................. ................. ................. .............................................'> ....................................'>
--.> --.>
Maintenance...... Maintenance.............. ................. .................. .................. .................. ................. ................. .................. .................. .................. ................'9 .......'9
--.9 --.9
"ut of !ervice.......... !ervice.................. ................. .................. .................. .................. ................. ............................................'9 ....................................'9
--.; --.;
14uipment 14uipment Temporarily Leaving The Laboratory........ Laboratory................. .................. ............................'9 ...................'9
--.-$ --.-$ )ecommissioning.. )ecommissioning........... .................. ................. ................. .................. .................. .................. ................. ................. .....................'9 ............'9 12. Samplin............... Samplin........................ .................. .................. .................. ................. ................. .................. .................. .................. ..............................25 .....................25 1,. eaents an# Calibration Stan#ar#s.................... Stan#ar#s............................. ................. ................. .................. .................... ...............,0 ....,0 14. !raceability !raceability of Measurements........... Measurements................... ................. .................. .................. ............................................,1 ...................................,1 1.Stability !estin.........................................................................................................,1 1*. 8an#lin of !est !est "tems................. "tems......................... ................. .................. .................. .................. ................. ................. .................. ................,2 .......,2 1+.!estin........................................................................................................................,, www.labcompliance.com www.labcompliance.com (Replace with your your company’s name) !E
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Master Plan Page ( of (# )ocument *umber+ M-## er. -.xx Laboratory Compliance 1. -uality of !est esults an# ailure "n'estiations...............................................,4 "n'estiations...............................................,4 -9.-
"ngoing "ngoing Performanc Performance e :ontrol :ontrol of the /nalysis /nalysis !ystem.......... !ystem................... .................. .................#3 ........#3
-9.'
"utof!pecifica "utof!pecification tion 0esults and &ailure Investigations....... Investigations................ ...........................#3 ..................#3
-9.#
0oot 0oot :ause /naly /nalysis sis and :orrectiv :orrective e and Preventiv Preventive e /ction /ction Plans...... Plans............ ...........# .....#( (
-9.3
)ata 0eview and alidation..... alidation............. ................. .................. .................. .................. ................. ............................#6 ....................#6
-9.(
0eporting 0eporting Test est 0esults.......... 0esults................... .................. ................. ................. .................. .................. ............................ ......................#6 ...#6
15. "#entification an# Manaement of ecor#s.................... ecor#s............................. .................. ..............................,+ .....................,+ 20. eferences................... eferences............................ .................. .................. .................. ................. ................. .................. .................. .................. ......................., ..............,
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Primers and Master Plans............ Plans..................... .................. .................. .................. ................. ................. .................. ...............#; ......#;
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0eference 0eference Publications..... Publications............. ................. .................. .................. .................. ................. ......................... ...........................#; ..........#;
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/udio !eminars.......... !eminars................... ................. ................. .................. .................. .................. ................. ................. .........................3$ ................3$
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!tandard !tandard "perating "perating Procedures....... Procedures................ .................. .................. ................. ........................ ............................3............3-
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&)/ and International International 0egulations, 0egulations, ?uidelines ?uidelines and Presentations....... Presentations................ ..........3# .3#
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21. ttac(ments................... ttac(ments............................ .................. .................. .................. ................. ................. .................. ......................................4 .............................4
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Laboratory Laboratory Personnel........ Personnel................. .................. .................. .................. ................. ................. .................. .................. .................3( ........3(
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)ocument )ocument Master List.............. List....................... .................. ................. ................. .................. .................. ............................3( ...................3(
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Template mplate and 1xample 1xample to )ocumen )ocumentt Training Training 0e4uire 0e4uirement ments..... s........... ............ ........... ........36 ...36
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Template emplate to )ocument )ocument Training...... Training.............. ................. .................. .................. .................. ..............................3> .....................3>
'-.(
14uipment 14uipment List............... List....................... ................. .................. .................. .................. ................. ......................................39 ..............................39
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List with /uthori@ed /uthori@ed =sers of 14uipment........ 14uipment................. .................. ...................... ...............................3; ..................3;
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14uipment 14uipment 0ecords.......... 0ecords.................. ................. .................. .................. .................. ............................................($ ...................................($
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0ecording 0ecording !ampling )ata............... )ata....................... ................. .................. .................. .................. ..............................(.....................(-
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List of 0ecords to be /rchived...... /rchived............... .................. .................. ................. ................. ................................(.......................(-
'-.-$ :hecklist :hecklist for Testing............. sting...................... ................. ................. .................. .................. .................. ........................... .......................(' .....('
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Master Plan )ocument *umber+ M-## er. -.xx Laboratory Compliance
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Master Plan
Laboratory Compliance
1. "ntro#uction$ Scope an# %b&ecti'es of t(is )ocument "ntro#uction
This Laboratory :ompliance Master Plan documents The LaboratoryAs approach and steps for compliance with &)/ and e4uivalent international regulations. !(e Laboratory
The Laboratory performs analyses of raw material, intermediates and finished products and performs stability tests at a pharmaceutical manufacturing site. The site manufactures drugs for the =nited !tates and international markets. Most of the processes are considered high risk because pharmaceutical 4uality control laboratories are the last control step in drug manufacturing and after the analysis result is released the drug products are shipped to the market. /s of the release date of this master plan BMarch '$$6C, The Laboratory has 9( employees, 9 of them are employed part time. Scope of t(e Master Plan •
•
/nalytical laboratories in BbioCpharmaceutical manufacturing. =! &)/ and e4uivalent international ?xP regulations.
This master plan has been developed for a pharmaceutical 4uality control laboratory, however, the principles and approaches can be easily customi@ed and applied to other &)/ regulated laboratories, e.g., regulated development laboratories and for clinical studies. •
%b&ecti'es of t(e Master Plan
This laboratory master plan has several ob7ectives+ It serves as a guideline for how c?MP re4uirements can be implemented efficiently and consistently in The Laboratory. •
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Master Plan Page > of (# )ocument *umber+ M-## er. -.xx Laboratory Compliance It answers the inspectorAs 4uestion about the companyAs approaches for compliance in The Laboratory. •
It demonstrates management commitment and support for compliance in laboratories through its policy statement. •
It helps personnel at all management levels understand how compliance is approached and implemented in The Laboratory. •
•
•
/ssists in the preparation of pro7ect plans. It helps to produce and maintain high 4uality analytical data.
2. Policy The Laboratory produces high 4uality data and fully complies with =! &)/ and e4uivalent international ?xP regulations in a costeffective manner. This is achieved through+ 1ffective communication of the master plan to all employees and assurance of correct understanding of the plan. •
&ollowing documented processes and procedures for c?MP and 4uality relevant operations. •
•
:lear definition of roles and responsibilities for management and
staff. "ngoing monitoring of &)/ and international guidelines and timely adaptation of processes and procedures if necessary. •
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0iskbased processes and procedures.
:ontinuous evaluation and improvement of processes and procedures. •
alidation of critical processes, e4uipment hardware and computer systems. •
/de4uate design and control of facilities and environmental conditions. •
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?xP compliant recording and archiving of data.
1valuation and investigation of deviations from expected results with root cause analysis and corrective and preventive action plans. •
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!uitable handling of samples, chemicals and standards.
0egular system suitability tests or 4uality control checks before and in between sample analyses. •
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0eviewing and validating analytical data.
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Master Plan Page 9 of (# )ocument *umber+ M-## er. -.xx Laboratory Compliance !ufficient and appropriately 4ualified and trained personnel. •
/uditing of actual processes for compliance with documented processes and procedures. •
•
•
Management support. /nnual review of processes and procedures.
,. Structure of -MS )ocumentation This section of the master plan describes various types of documents and how they interrelate with each other. )ocumentation 8ierarc(y
There are different types of documentation as illustrated in the documentation pyramid in &igure -. The master plan is the top tier of the document hierarchy. It describes the approaches to achieve compliance and 4uality data. It also includes policy statements describing the intent and goal of The Laboratory and key points on how these goals can be achieved. The compliance master plan does not include detailed processes or procedures on how to achieve compliance but it does have a list of the processes and procedures. / process describes how various compliance and 4uality re4uirements can be achieved. &or example, it describes how the re4uirement Dpeople should be 4ualified for the assigned taskE can be implemented. Procedures are stepbystep instructions on how to exactly perform a specific task for a specific instrument. )epending on what the task is this can have the form of an !"P or a test script. 1xamples are how to analy@e sample F, how to calibrate balance / from vendor G or how to test a specific chromatographic data system. 0ecords are generated on a daybyday basis. 1xamples are analytical results from product tests or calibration records of a balance.
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Master Plan )ocument *umber+ M-## er. -.xx Laboratory Compliance
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iure 1. )ocumentation 8ierarc(y Laboratory Compliance an# Corporate Master Plans
Master plans are documents that lay out a companyAs approach for specific activities, e.g., how to achieve compliance for a laboratory. /pproaches for laboratories cannot be isolated from other activities and master plans in the organi@ation. &or example, risk management strategies as defined in a corporate risk management master plan should also apply to laboratory system validation. Training for laboratory staff should be conducted and documented following the companyAs training master plan. /lthough this laboratory compliance master plan provides enough information to implement a compliance program in The Laboratory, it does not give enough details for supporting tasks. &or example, it does not include detailed information for validating computer systems, on preparing, conducting and documenting trainings, or information on password conventions and risk management strategies. 8owever, these activities are also important for The LaboratoryAs compliance strategies. Therefore there must be a tight link between The Laboratory master plan and other master plans. &or a better understanding this chapter describes other master plans available in the organi@ation. #.'.-
0isk Management Master Plan B'$.-.-C
The risk management master plan describes the companyAs approach for risk assessment and risk management, for example, to comply with the &)/As Part -- ?uidance+ D!cope and /pplicationsE based on a www.labcompliance.com (Replace with your company’s name) !E
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Master Plan Page -$ of (# )ocument *umber+ M-## er. -.xx Laboratory Compliance D7ustified and documentedE risk assessment. It is used as a source for pro7ect specific individual risk management pro7ect plans. /n example master plan is included in the Laboratory :ompliance Package from Labcompliance. #.'.'
14uipment ualification Master Plan B'$.-.'C
The e4uipment 4ualification master plan describes the companyAs approach for 4ualifying e4uipment such as analytical instruments. It also details steps for e4uipment 4ualification and owners and deliverables for the 4ualification phase. #.'.#
:omputer !ystem alidation Master Plan B '$.-.#C
The computer system validation master plan describes the companyAs approach for validation of software and computer systems. It is used as a source for pro7ect specific individual validation plans. #.'.3
*etwork ualification Master Plan B '$.-.3C
The network 4ualification master plan describes the companyAs approach for 4ualifying IT infrastructure and networks. It is used as a source for pro7ect specific individual 4ualification plans. #.'.(
'- :&0 Part -- :ompliance Master Plan B '$.-.(C
The Part -- compliance plan describes the companyAs approach and steps for implementing compliant electronic records and electronic signatures. /n example master plan is included in the '- :&0 Part -:ompliance Package from Labcompliance+ www.labcompliance.com%books%part--. #.'.6
Training Master Plan B'$.-.6C
The training master plan describes the companyAs approach on how to identify training needs for employees, how to develop and implement a training plan, how to conduct trainings and finally how to document the trainings. Trainings for laboratory staff should follow the recommendations in this master plan. #.'.>
:alibration and Preventive Maintenance Master Plan B '$.-.>C
The calibration and preventive maintenance master plan describes the companyAs approach for calibration and maintenance of e4uipment.
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Master Plan )ocument *umber+ M-## er. -.xx Laboratory Compliance Processes
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Processes describe how various compliance and 4uality re4uirements can be achieved. &or example, it describes how the re4uirement Dpeople should be 4ualified for the assigned taskE can be implemented. /nother example is how to make sure that De4uipment is suitable for its intended useE. In this case the processes on e4uipment 4ualification apply to instrument categories such as analytical e4uipment hardware or more specific to an instrument family such as =I! !pectrophotometers, but processes are not like specific instruments identified by a product number. &or a better understanding process flow charts should be included in a process description. Processes typically are documented in standard operating procedures. / list of !"Ps for various processes is included in 0eference '$.3. Proce#ures an# 9or "nstructions
0outine activities follow documented procedures. These are typically defined as standard operating procedures and%or work instructions.
&)/ and e4uivalent international regulations re4uire a specific type of information to be retained for a specific amount of time.. &or example, '- :&0 '--.-;3 defines which laboratory records should be retained and archived and the duration. 1xamples are results of product tests and measurement parameters, calibration results, sample descriptions and instruments used for testing. Gesides the records explicitly mentioned in regulations, the &)/ expects that other records are available to demonstrate compliance with the :?MP regulations. 1xamples are training records to demonstrate compliance with people training and environmental monitoring records to comply with the re4uirement to ade4uately control environments. The Laboratory ac4uires and maintains all records as re4uired by the &)/ and e4uivalent international regulations for at least the specific time as defined in regulations. The exact retention period for each type of record is defined by corporate policies.
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Master Plan )ocument *umber+ M-## er. -.xx Laboratory Compliance C(eclists$ orms$ !emplates$ 3;amples
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:hecklists, forms, templates and examples help implement compliance effectively and consistently. 1xamples are checklists and worksheets for vendor 4ualification, handling outofspecification results and for Part -compliance. Templates are available for system documentation, test protocols, maintenance and change logs.
4. %rani/ation an# esponsibilities 0esponsibilities of management and staff are defined and annually reviewed.
iure 2. %r C(art
/ttachment '-.- lists laboratory personnel with names, positions, education level and years of experience Btotal%current positionC.
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Master Plan )ocument *umber+ M-## er. -.xx Laboratory Compliance Manaement
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Management is responsible for reviewing, approving, supporting and communicating the 4uality and compliance policy to employees. 0esponsibilities and tasks include+ Management team is responsible for annually reviewing the compliance and 4uality system. •
The president has executive responsibility for compliance and shall create an atmosphere where compliance and 4uality are the highest priority. •
The vice presidents are responsible for overseeing the development, implementation and maintenance of compliance systems. •
1ach manager and supervisor is responsible for assuring that the compliance systems are implemented in his%her area. •
-uality ssurance
The uality /ssurance department sets up the compliance system and assists The Laboratory in the development, implementation and maintenance of the system. Tasks and responsibilities include+ !et compliance and 4uality goals and ob7ectives for The Laboratory and develop plans to meet those goals and ob7ectives. •
Manage and participate in periodic audits to assure that compliance systems are implemented faithfully and effectively. •
Train and advise management, supervisors and staff on 4uality aspects and regulations and internal policies. •
0ecommend solutions to compliance problems and verify when any problems have been resolved. •
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0eport 4uality related issues to management.
Manage &)/ and other external inspections and audits. Initiate corrective and preventive actions if necessary. •
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"versee initial and ongoing instrument calibration and 4ualification.
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"versee the annual maintenance service.
"versee the documentation, archiving and distribution of laboratory standard operating procedures. •
•
?enerate !"Ps for nonanalytical 4uality related operations.
0eview all !"Ps and other documents for completeness and compliance with company standards and regulations. •
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Master Plan )ocument *umber+ M-## er. -.xx Laboratory Compliance 0eview analytical data.
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•
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Issue data summaries for annual product reviews.
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"rgani@e annual management review of the compliance system.
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Manage vendor assessment and audits.
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Manage complaints.
)epartment Manaer an# Super'isors
Lab managers and supervisors implement company policies and standards in their laboratories. Tasks and responsibilities include+ /ssure compliance with &)/ and e4uivalent international regulations. •
0esponsible for the overall technical 4uality of the work performed in The Laboratory. •
•
!upervision of all personnel in The Laboratory.
1nsure management procedures, applicable standards and specifications are followed. •
•
)evelop 7ob descriptions for staff working in their departments.
1nsure that sufficiently 4ualified, skilled and trained personnel and other resources are available to perform the assigned tasks. •
1nsure that 7ob descriptions, tasks lists and training records are maintained to demonstrate staff competence for the assigned tasks. •
1nsure that The Laboratory has appropriate e4uipment and supplies. •
!chedule analytical sample analysis and ensure completion of analyses within re4uired schedule. •
Provide technical assistance to analysts regarding the selection of appropriate analytical methods. •
0eview and approve analytical method validation protocols and stability study protocols. •
•
0eview and validate all data before it is reported as final.
?enerate and maintain !tandard "perating Procedures B!"PsC for laboratory operation within his%her own work area. •
!chedule initial and ongoing e4uipment 4ualification and preventive maintenance. •
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Master Plan Page -( of (# )ocument *umber+ M-## er. -.xx Laboratory Compliance /ssist analysts with handling outofspecification situations, failure investigations, root cause analysis and corrective and preventive action plans. •
Identify and report any opportunities to improve efficiency, compliance and 4uality. •
nalysts
/nalysts should perform their assigned tasks according to company procedures in the most costeffective way. Tasks and responsibilities include+ •
0esponsible for the technical 4uality of work performed.
•
&ollow !"Ps and /%: re4uirements for routine tasks.
•
Perform sample analysis and document results.
:alibrate balances and other e4uipment on a daybyday basis, if re4uired by !"Ps. •
Inform direct supervisors when analytical results are not in specification. •
•
/ssist supervisor in data review if necessary.
Identify and report any opportunities to improve efficiency, compliance and 4uality. •
Safety %fficer
The safety officer manages activities re4uired to ensure a safe and healthy laboratory environment. Tasks and responsibilities include+ )evelop, implement and maintain laboratory safety plan and material safety data sheets. •
•
Train laboratory employees on the laboratory safety plan.
•
Manage ha@ardous waste storage and disposal.
•
Manage laboratory safety audits.
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Master Plan )ocument *umber+ M-## er. -.xx Laboratory Compliance
Page -6 of (#
. acilities an# 3n'ironmental Con#itions Laboratory facilities ensure that environmental conditions do not adversely affect or invalidate sample handling instrumentation, instrument calibration and 4ualification and analytical testing. Procedures are described in !"P !-(- B0ef. '$.3C. &ollowing the !"P ensures that+ Laboratories are e4uipped with climate and ventilation control. Laboratory facilities meet the re4uired environmental conditions, e.g., temperature and humidity, as specified by instrument manufacturers and as re4uired for sample processing. •
&loors in the laboratories are constructed from a material that is resistant to most chemical spills and easily disinfected. •
The Laboratory is e4uipped with chemical hoods to capture ha@ardous materials used or produced in the analysis and to protect employees from ha@ardous concentrations of airborne toxic substances. •
/n auxiliary power generating system is in place to provide emergency power for ha@ardous or sensitive operations. •
Laboratory storage areas provide proper storage of samples, standards and reagents. •
!torage areas of sufficient si@e are present in The Laboratory to ensure that glassware and portable instrumentation are properly stored. •
!eparate areas are maintained for incompatible activities, and measures are taken to prevent crosscontamination. •
The Laboratory areas are separated from other sections in the building such as administration services, lunch room and conference rooms. •
/ny additional laboratory conditions for specified analysis conditions are met, including ha@ardous biological and chemical material. •
•
Laboratories are cleaned and maintained according to a schedule.
•
!upervisors implement environmental control programs in The Laboratory.
!upervisors recogni@e when environmental conditions are not met and adversely affect tests being performed. /nalysis is not performed if monitoring reveals that re4uired environmental conditions are not met. •
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Master Plan Page -> of (# )ocument *umber+ M-## er. -.xx Laboratory Compliance Laboratory employees plan and conduct laboratory operations in designated areas. •
Laboratory employees identify and suggest implementing any environmental controls needed to complete sampling and analysis, and ensure that these factors do not adversely affect the 4uality. •
Laboratory employees properly handle and store ha@ardous waste as defined in the 8a@ardous
0elated !"P H 0eference '$.3 !-(-+ &acilities and 1nvironmental :onditions
*. )ocument Control )evelopment and maintenance of documentation is controlled through document control and management procedures B!"Ps !-$( and !($3C B0ef. '$.3C that are part of the management system. )ocuments include internal and external documents. 1xamples for internal documents are !"Ps, master plans and training plans. 1xamples for external procedures are regulations, standards, test methods and instrument operating manuals. The procedure for document control ensures that+ "fficial internal and external documents are created or ac4uired, reviewed and approved prior to use. •
)ocuments are uni4uely identified with document and revision number, date of revision and issuing authority. •
/ master list with all controlled documents is maintained by /. The list includes document and revision number, title, date of issue, date of last review and locations. / template with examples is shown in /ttachment '-.'. •
Internal documents include page number and total number of pages on each page. •
=sers of the documents are ade4uately trained before the documents are released for use. •
:urrent authori@ed versions are readily available at the userAs workspace. •
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Master Plan Page -9 of (# )ocument *umber+ M-## er. -.xx Laboratory Compliance )ocuments are reviewed according to a schedule and revised to ensure suitability and ongoing conformance with regulations and internal procedures. •
Invalid and obsolete documents are promptly removed from all points of issue or use, or marked as uncontrolled to assure that only current authori@ed versions of appropriate documents are available for active use at relevant locations. •
"bsolete documents retained for either legal or knowledge preservation are marked as “ Archived ” , dated and signed. The retention period for the documents is in compliance with internal policies and regulations. •
•
:hanges to a document are reviewed and approved.
The changes are recorded in a document change log. The log information indicates the reason and the nature of the change. •
0elated !"Ps H 0eference '$.3 !-$(+ )ocument :ontrol and Management !-#>+ '- :&0 Part -- H !cope and :ontrols !#-(+ 0etention and /rchiving of 1lectronic 0ecords !#-6+ !canning of Paper 0ecords for ?xP :ompliant /rchiving !#->+ )ata Gackup and 0estore !($3+ ?eneration and Maintenance of !"Ps for Laboratories
+. "nternal u#its Internal audits verify conformance of actual work with documented procedures. They are conducted according to !"P !(-- B0ef. '$.3. The procedure includes an audit schedule that ensures that all entities are audited over a certain time period. &or an audit checklist, see 1-93 B0ef. '$.6C. The internal audit program addresses all elements of the compliance and 4uality systems, including testing and people 4ualification. / is responsible for the coordination of internal audits and also develops an audit schedule. The procedure for internal audits ensures that+ www.labcompliance.com (Replace with your company’s name) !E
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Master Plan Page -; of (# )ocument *umber+ M-## er. -.xx Laboratory Compliance The audits are conducted by trained and 4ualified personnel. •
/udits are ob7ective through auditors coming from outside the audited department. •
/udits are conducted in a similar way to anticipated &)/ or e4uivalent international inspections. •
)eviations from procedures are corrected through The LaboratoryAs corrective action plan. •
1ach area of activity is audited and audit findings and corrective action that arise from them are recorded. •
&ollowup audit activities are conducted to verify and record the implementation and effectiveness of the corrective action taken. •
&ollowup activities are included in the annual management review process. •
0elated !"Ps H 0eference '$.3 !(--+ /uditing Laboratory !ystems !-3-+ &)/ Inspections Preparation, :onduct, &ollowup !-3'+ Multinational ?MP Inspections+ Preparation, :onduct and &ollowup
. Manaement e'iews Management reviews verify continuous fitness for use and effectiveness of the management system and initiate changes for improvements if needed. They are conducted according to a procedure in !"P !(-$ B0ef. '$.3C. The review serves as a guide in making future determinations for the effectiveness and direction of the 4uality and compliance system. /s a minimum, the review is performed annually. The review is conducted by The LaboratoryAs executive management. The procedure for management includes but is not limited to the following elements+ •
!uitability of policies, processes and procedures.
•
0eports from managers and supervisors.
•
"utcome of recent internal audits.
•
0ecalls, returned or salvaged drug products.
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Master Plan Page '$ of (# )ocument *umber+ M-## er. -.xx Laboratory Compliance &ailure investigations, corrective and preventive actions. •
•
/ssessments by external bodies, &)/ inspection findings. :hanges in the volume and type of work.
•
:omplaints and other feedback from users of the analytical test results. •
uality control activities, resources and staff training.
•
The findings and the actions that arise from the review are recorded according to The LaboratoryAs management review procedure. If needed, corrective actions are initiated. 0elated !"P H 0eference '$.3 !(-$+ Laboratory Management 0eview
5. Staffin an# People -ualification Laboratory management ensures that The Laboratory has sufficient resources and personnel that have the education, expertise, training or a combination of these to perform their assigned tasks. Proce#ure
:ompetence of people is based on education, experience, demonstrated skills and training. People 4ualification is controlled through !"P !(-# B0ef. '$.3C. The procedure for training ensures that+ •
•
•
•
•
*ew hires complete an initial training module. !uch trainings include basics of the =! &)/ and e4uivalent international regulations, principles of 4uality systems, safety, security and company procedures. Training re4uirements are defined, outlined and documented on the basis of 7ob descriptions or duties, assigned tasks and responsibilities. Personnel records contain the assigned tasks, re4uirements and competence through education, experience, skills and training. If the competence does not meet the re4uirements, a training plan is developed. This includes training needs and a training schedule. &or inhouse trainings a senior analyst serves as the trainer.
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Master Plan Page '- of (# )ocument *umber+ M-## er. -.xx Laboratory Compliance &or external trainings the competence of the trainer and%or the company providing the training is documented. /nalysts are trained and must demonstrate competence before they generate the first analytical results. Laboratory managers identify personnel to perform testing and calibration, to 4ualify e4uipment, to issue test reports and operate particular types of instruments. /ll personnel are 4ualified for the assigned task, this includes all levels of management and both full time personnel and temporary hires. /s the first step, the supervisor documents the assigned task, re4uired skills, the personAs 4ualification and whether additional training is re4uired or not. /n example for a form is shown in /ttachment '-.#. The competency of the trainee is demonstrated and documented after the training. /n example for a form is included in /ttachment '-.3. :ompetence and re4uirements are reviewed between the individual and supervisor in annual meetings. Training not only includes technical competence but also knowledge on the &)/ and e4uivalent international regulations. Training in The Laboratory includes all methods and techni4ues that personnel are asked to perform.
•
•
•
•
•
•
•
•
!rainin Courses an# !ools for Pre< or Self
8uman resources together with laboratory management search for and recommend training courses. Trainers come from The Laboratory and also from outside. Training tools are available from The Laboratory library for pre or selfstudy and to assist trainers in developing and conducting training courses. / list of training tools is included in :hapter '$. They include+ • • • • •
Primers and master plans 0eference publications /udio seminars &)/ and international regulations and guidelines !tandard operating procedures
ssessment !ools
The effectiveness of trainings and competence is evaluated and documented following the !"P !(-# B0ef. '$.3C. /ssessment tools include+ •
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Master Plan )ocument *umber+ M-## er. -.xx Laboratory Compliance Interview by supervisor or trainer. "bservation of an employee performing a procedure. Testing blind : samples. Testing of known samples. Testing of previously analy@ed samples.
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• • • • •
0elated !"Ps H 0eference '$.3 !-'(+ Training for ?xP, '- :&0 Part -- and :omputer alidation !(-#+ Training for Laboratory Personnel
10. Selection an# 6ali#ation of nalytical Met(o#s an# Proce#ures /nalytical methods for product and stability testing are properly selected and validated to ensure that they are suitable for their intended use. Met(o# Selection
The Laboratory validates nonstandard methods following the !"Ps !6-' and !6-# B0ef. '$.3C. The procedures follow the validation life cycle approach and include the following steps+ •
)efinition of the application, purpose and scope of the method.
•
!pecification of performance parameters and acceptance criteria.
•
)efining validation experiments.
•
erification of relevant performance characteristics of e4uipment.
ualification of materials, e.g. standards and reagents. www.labcompliance.com (Replace with your company’s name) FOR INTERNAL •
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Master Plan )ocument *umber+ M-## er. -.xx Laboratory Compliance Performing prevalidation experiments.
Page '# of (#
•
/d7usting method parameters and%or acceptance criteria if necessary. •
•
Performing full internal Band externalC validation experiments.
•
)efining criteria for revalidation.
)efining type and fre4uency of system suitability tests and%or /nalytical uality :ontrol B/:C checks for the routine. •
•
)ocumenting validation experiments and results in the validation
report. The extent and type of validation and the acceptance criteria depend on the application. alidation experiments can include+ •
accuracy
•
precision
•
specificity
•
limit of detection
•
limit of 4uantitation
•
linearity
•
range
•
ruggedness
•
robustness
)epending on the intended use and scope of the method, all or part of the parameters will be tested. 6erification of Stan#ar# Met(o#s
!tandard methods generally follow the same life cycle principle. &or standard methods first define the scope and performance specifications of the method as re4uired by The Laboratory. If the scope of the standard method matches the scope and specifications of The Laboratory method -$$ only the competence of The Laboratory and suitability of e4uipment to successfully run the method will be verified. This typically includes repetition of two validation experiments and running system suitability tests or 4uality control samples. /ny parameter outside The Laboratory specification is validated similarly to methods developed in The Laboratory B -$.'C.
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Master Plan )ocument *umber+ M-## er. -.xx Laboratory Compliance Met(o# e'ali#ation
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The method will be revalidated if it is out of the initial scope or specifications after changing sample characteristics, instrument characteristics or method parameters. =sin lternati'e Met(o#s
If standard methods exist but because of technical or business reasons The Laboratory intends using alternative methods, The Laboratory demonstrates e4uivalency of the alternative method to the standard method. To demonstrate e4uivalency The Laboratory, at a minimum, analy@es four consecutive split samples using the standard method and the alternative method. The alternative method can be used if the results of the comparison meet pre established acceptance criteria. =sin Software for utomate# Met(o# 6ali#ation
11. 37uipment an# Computers The Laboratory has e4uipment for sample preparation, testing and data processing. !oftware is used for instrument control, data ac4uisition, data evaluation and for archiving and retrieval of data. Procedures for proper selection, 4ualification and maintenance of analytical instrument hardware and software ensure that the e4uipment is suitable for its intended use. 14uipment hardware is purchased from vendors. !oftware is also purchased if available. &or specific pro7ects The Laboratory develops software either as a standalone package or as an addon to commercial software. 14uipment is ade4uately calibrated, 4ualified and%or validated and maintained to ensure high system uptime, data accuracy,
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Master Plan Page '( of (# )ocument *umber+ M-## er. -.xx Laboratory Compliance confidentiality and integrity. To ensure data integrity computer systems comply with the &)/As regulation for electronic records and signatures+ '- :&0 Part --. 37uipment "#entification
1ach item of e4uipment hardware and each computer system used for testing has an identification number that is uni4ue to each instrument. Information on the e4uipment is entered in the system inventory database. Initial and%or updated information includes+ •
instrument description
•
manufacturerAs name
•
serial number or other uni4ue identification
•
firmware or software revision
•
location of installation and use
•
date of installation
•
calibration%4ualification%validation status
•
any damage, malfunction, modification and repair
/n example of a form for the e4uipment documentation is shown in /ttachment '-.(. 37uipment Los
0ecords are maintained for each item of e4uipment with information on calibration and%or 4ualification, re4ualification, performance checks, damage, malfunctions, modifications and updates. /n example for a template is shown in /ttachment '-.>. /ll documents necessary to support the above mentioned events or activities are also maintained. 1xamples are results of performance checks, calibration plots, calibration certificates and vendor declarations. -ualification of 37uipment 8ar#ware
The Laboratory 4ualifies e4uipment following the !"P !'3$ B0ef. '$.3C. The procedure ensures that+ •
ualification activities follow a documented 4ualification plan.
The instrument design meets The Laboratory re4uirements for the intended use through a formal design 4ualification. )uring the design •
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Master Plan Page '6 of (# )ocument *umber+ M-## er. -.xx Laboratory Compliance 4ualification the vendorAs functional and performance specifications are verified for compliance with The LaboratoryAs specifications. Instruments are developed and manufactured in a 4uality environment. This is verified through a formal vendor assessment. •
Instruments are installed according to vendor specifications. The installation process is documented through formal installation 4ualification. Larger systems are installed by vendor representatives while smaller systems by laboratory staff. In both cases the laboratory supervisor signs off the installation 4ualification documents. •
Instruments are calibrated and%or 4ualified according to !"Ps specifically designed for instrument categories. &or examples see !"P !63- and !"P !633 B0ef. '$.3C. •
"ngoing performance is ensured through periodic testing of critical parameters that may be impacted by the use of the system. /n example is a regular check of the intensity of 8PL: = detector lamps. This ensures that specifications for the limit of detection and limit of 4uantitation are met on a daybyday basis. •
14uipment hardware is fully revalidated or recalibrated at regular time intervals to ensure proper functioning. The schedule for the re4ualification is defined for each instrument category. •
1ach piece of e4uipment is labeled with the calibration or 4ualification status. Information includes dates of the last and next scheduled calibration%4ualification. •
ualification results are summari@ed in a 4ualification summary report that mirrors the 4ualification plan. •
%ff
The Laboratory validates commercial offtheshelf computer systems following the !"P !6(6 B0ef. '$.3C. The procedure ensures that+ •
alidation activities follow a documented 4ualification plan.
The computer system design meets The LaboratoryAs re4uirements for the intended use through a formal design 4ualification. )uring the design 4ualification the vendorAs functional specifications are verified for compliance with The LaboratoryAs specifications. •
!oftware and computer systems are designed, developed and manufactured in a 4uality environment. The software is validated during all development phases according to documented software development life cycle procedures. endors are able to support the computer systems. This is ensured through a vendor assessment program following !"Ps !'># and !'>3 B0ef. '$.3C. •
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Master Plan Page '> of (# )ocument *umber+ M-## er. -.xx Laboratory Compliance The computer systems are installed according to vendor specifications. The installation process is documented through formal installation 4ualification. )uring or after the installation the system is documented with hardware items, firmware revision, operating and application software and revisions and any accessories. &or an example, see 1#'' in 0eference '$.6. Larger systems are installed and documented by vendor representatives, smaller systems by laboratory staff. In both cases the laboratory supervisor signs off the installation 4ualification documents. •
!oftware and computer systems are tested in the userAs environment following the concept of riskbased validation. The procedure is described in !"P !#'- B0ef. '$.3C. Tests are limited to key functions and functions that are impacted by the environment. &or configurable systems the configurations as set by the users are tested in The Laboratory. !ecurity access is always tested because it is a critical function and is typically configured for specific users. •
"ngoing performance is ensured through periodic testing of the complete system, when applicable, and through a rigorous change control procedure. The change control procedure re4uires a risk assessment and an evaluation of what and how much revalidation is re4uired after the change. /ll changes are recorded in the system logbook. •
alidation results are summari@ed in a 4ualification summary report that mirrors the validation plan. •
/n annual review of the computer system verifies that actual system status and validation is in compliance with the documentation. •
6ali#ation of Software )e'elope# "n<8ouse
The Laboratory validates software that is developed inhouse following the !"P !'6# B0ef. '$.3C. 1xamples for such software include standalone software packages such as completely custom built statistical packages and also addon software, for example Macros for data systems. /lso included in this category are commercial spreadsheet applications such as M! 1xcelJ or databases such as M! /ccessJ. The design, development and use follow the !"P !'66 B0ef. '$.3C. The procedure ensures that+ !oftware is designed, developed and validated in a controlled environment and the process is documented. •
The software design meets The Laboratory re4uirements through review of specifications by the users departments. •
1very software installation is documented and entered in the e4uipment inventory database. •
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Master Plan Page '9 of (# )ocument *umber+ M-## er. -.xx Laboratory Compliance The software is tested in the userAs environment using the userAs application. /ll functions are tested under normal, boundary and stress conditions. •
:hanges to the software follow a documented change control procedure. The procedure re4uires a risk assessment and an evaluation of what and how much revalidation is re4uired after the change. /ll changes are recorded in the system logbook. •
%peration
/uthori@ed and well trained personnel operate the e4uipment. / list of authori@ed users is maintained for each e4uipment. /n example for a template is included in /ttachment '-.6. =ptodate instructions on the operation and maintenance are readily available for appropriate use by the appropriate personnel. Maintenance
14uipment hardware and computer systems are maintained to ensure correct functioning and minimum downtime. Maintenance activities follow the !"P !(3- B0ef. '$.3C. The procedure ensures that+ /ll parts are listed in the parts inventory database with criticality for operation and anticipated usage. •
:ritical parts are stored in a storage room close to The Laboratory to ensure fast availability when needed. •
:ritical parts are regularly exchanged. !chedule for exchange is based on experience and vendor recommendations. •
Time schedule for exchange is based on measured performance or the part used if possible, if this is not possible, the schedule is based on linear time. •
:omputer systems are regularly checked for viruses following the procedure in !"P !#'- B0ef. '$.3C. •
%ut of Ser'ice
14uipment not meeting specifications, defective e4uipment and e4uipment that cannot be used for other reasons, for example, e4uipment that has been sub7ect to overloading or mishandling, or e4uipment that gives suspect or out ofspecification results is taken out of service. It is isolated and clearly labeled as being D"ut of !erviceE to prevent its use until it has been repaired and verified to be suitable for itAs intended use through calibration or 4ualification.
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Master Plan )ocument *umber+ M-## er. -.xx Laboratory Compliance 37uipment !emporarily Lea'in !(e Laboratory
Page '; of (#
#+ /uditing !oftware !uppliers+ Preparation, :onduct, &ollowup !'>3+ uality /ssessment of !oftware and :omputer !ystem !uppliers !#'-+ irus :hecks of IT !ystems !($;+ :hange :ontrol of /nalytical 14uipment !(-;+ 0isk /ssessment for Laboratory !ystems !(3-+ Maintenance of Laboratory 14uipment !6'9+ )evelopment of =ser 0e4uirement !pecifications for /nalytical 14uipment !63-+ :alibration of /nalytical Galances !633+ ualification of 0efrigerators !6(6+ alidation of Laboratory :omputer !ystems !66'+ 0iskGased alidation of Laboratory :omputer !ystems
12. Samplin !amples are usually taken from production. Persons taking samples are either laboratory or production staff. In either case, sampling of substances, materials or products for subse4uent testing follows the !"P !(#- B0ef. '$.3C. Procedures for sampling specific materials are available at the location where sampling is undertaken. The procedure ensures that samples are taken according to a sampling plan to be representative based on scientifically sound sampling www.labcompliance.com (Replace with your company’s name) !E
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Master Plan Page #$ of (# )ocument *umber+ M-## er. -.xx Laboratory Compliance methods. The procedure also re4uires recording of sampling data such as sampling procedure used, location, the identification of the person who took the sample, the substance name or description, batch number, 4uantity, e4uipment used for sampling and environmental conditions, if relevant. /n example for a template is shown in /ttachment '-.9. 0elated !"P H 0eference '$.3 !(#-+ !ampling for /nalytical Testing
1,. eaents an# Calibration Stan#ar#s 0eagents and calibration standards are prepared or purchased following the !"P !(#' B0ef. '$.3C. This ensures+ 0eagents and calibration standards are purchased from 4ualified vendors or are prepared from reagent grade materials. •
!tandards and reagents are prepared using :lass / volumetric glassware and calibrated dispersing devices. •
/ll vendor supplied standards and reagents are recorded in an electronic database. 0ecorded information includes as a minimum+ vendor, date received, lot number and expiration date. •
•
The type of standards used in The Laboratory is defined.
!tandards prepared in The Laboratory are recorded in an electronic database. Information includes date of preparation, person who prepared it, expiration date, 4uantity, storage conditions and the procedure used to prepare the standard. •
!tandards and reagents are labeled with the standard or reagent name or description, concentration, date of preparation and date of expiration. )ocumented information is sufficient to allow traceability to the preparation record that provides traceability of all ingredients. •
Manufacturer specifies expiration dates for standards and reagents. If no information is available from the manufacturer it is determined based on best scientific 7udgment or through experiments, if necessary. •
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Master Plan Page #- of (# )ocument *umber+ M-## er. -.xx Laboratory Compliance
0elated !"P H 0eference '$.3 !(#'+ Preparation of :alibration !tandards
14. !raceability of Measurements Measurement devices are traceable to national or international standards when a traceable standard is available. 1xamples for measurement devices with traceability to national standards are balances and thermometers. &or an example on determination of accuracy see !"P !(## B0ef. '$.3C. :ontracting companies providing calibration or 4ualification services provide evidence of measurement traceability of its own measurement standards and measurement e4uipment. This is done by means of an unbroken chain of calibration or comparisons linking them to primary standards. 0eference standards used in the lab or by e4uipment calibration or 4ualification service providers are traceable to national or international standards, if such standards are available. /n example is caffeine to calibrate the wavelength accuracy of 8PL: = detectors. :ontracting companies providing calibration or 4ualification services also provide documentation demonstrating competence to perform these services. :alibrations that cannot provide strict measurement traceability to national or international standards are conducted such that the calibration results can generate confidence in the measurements made in the course of the analyses.
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Master Plan )ocument *umber+ M-## er. -.xx Laboratory Compliance 0elated !"P H 0eference '$.3
Page #' of (#
!(##+ Measurement Traceability
1. Stability !estin The Laboratory has a written testing program designed to assess the stability characteristics of drug products. The results of such stability testing are used in determining appropriate storage conditions and expiration dates. !tability testing follows the !"P !((- B0ef. '$.3C. &ollowing this procedure ensures+ !ample si@e and test intervals are based on statistical criteria for each attribute examined to assure valid estimation of stability. •
•
0eliable, meaningful, validated and specific test methods are used.
!torage of the drug product in the same containerclosure system as that in which the drug product is marketed. •
Testing of drug products for reconstitution at the time of dispensing Bas directed in the labelingC as well as after they are reconstituted. •
/n ade4uate number of batches of each drug product are tested to determine an appropriate expiration date and a record of this data is maintained. •
/ccelerated studies, combined with basic stability information on the components, drug products and containerclosure system is used to support tentative expiration dates provided full shelf life studies are not available and are being conducted. •
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Master Plan )ocument *umber+ M-## er. -.xx Laboratory Compliance 0elated !"P H 0eference '$.3
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!((-+ !tability Testing
1*. 8an#lin of !est "tems The Laboratory ensures proper identification and protection of samples from the time the sample is taken until its disposal. 0eceipt, protection, storage, processing, retention and disposal is described in the !"P !(#3 B0ef. '$.3C. The procedure includes provisions for protection against deterioration, loss or damage during transportation, handling and storage.
The identification of samples follows the !"P !(#3 B0ef. '$.3C. The procedure ensures uni4ue identification of samples through a sample number. The sample number is used to track the sample from the time the sample is collected until the analysis is completed. The sample number is also used to provide traceability between the sample and test results. •
•
Procedures for processing of samples are defined for each sample.
/n appropriately identified reserve sample that is representative of each lot in each shipment of each active ingredient is retained. •
The reserve sample consists of at least twice the 4uantity necessary for all tests to determine whether the product meets its established specifications. •
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Master Plan )ocument *umber+ M-## er. -.xx Laboratory Compliance 0elated !"P H 0eference '$.3
Page #3 of (#
!(#3+ 8andling of Laboratory Test Items
1+. !estin :orrect testing is most important to achieve accurate and reliable results. /nalyst use and follow a checklist to ensure that+ •
1ach test follows a written procedure that is specific for the test.
•
"nly validated methods are used for testing.
•
"nly 4ualified e4uipment is used for testing.
•
Testing is performed by 4ualified people.
The system is calibrated before the first sample run and within a series of runs sufficient calibrations are performed. •
!ystem suitability tests are performed before the first sample run and for se4uences within and at the end of the se4uence. •
•
•
/cceptance criteria are specified for each test. Test results are documented according to a protocol.
Test procedures and parameters are documented with sufficient detail such that sample runs including data evaluation can be repeated based on this documentation •
•
/n example for a checklist is included in /ttachment '-.-$
1. -uality of !est esults an# ailure "n'estiations The Laboratory ensures high 4uality measurements and reporting of test results through the implementation of multiple measures or mechanisms such as+ "ngoing control of system performance through system suitability tests or analysis of 4uality control samples. •
Procedures for handling outofspecification results with root cause analysis and corrective and preventive action plans. •
•
)ata review through the analystAs supervisor and /.
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Master Plan )ocument *umber+ M-## er. -.xx Laboratory Compliance Procedures for reporting of analysis results.
Page #( of (#
•
%noin Performance Control of t(e nalysis System
The Laboratory follows !"P !6'- B0ef. '$.3C to ensure ongoing performance of the analysis system. )epending on the system, ongoing performance is controlled through+ •
!ystem suitability test before, in between and after sample runs.
0egular analysis of 4uality control samples and monitoring the data and trends in 4uality control charts. :ontrol criteria and corrective actions are specified for 4uality control sample results. )iscrepant results are documented and The Laboratory supervisor is informed. The supervisor initiates followup activities, e.g., flags test results. •
%ut
)eviations from expected test results are handled following the !"P !--( B0ef. '$.3C. This procedure ensures that+ •
/nalysts are aware of potential problems.
•
/nalysts stop testing in case of an "utof!pecification B""!C
result. •
/nalysts inform the supervisor in case of an ""! result.
!amples are retained until data is reviewed and the investigation is finished. •
/nalysts together with the supervisor document the ""!, each step of The Laboratory failure investigation and investigation results. •
•
The supervisor reviews and accepts or re7ects the test results.
The supervisor goes through the details of failure investigations with the analyst. •
•
The supervisor informs the / manager about the ""!.
•
The supervisor approves the failure investigation.
The supervisor together with the analyst identifies the root cause of the failure. •
The supervisor together with the analyst evaluates if the problem could occur on other systems. •
The supervisor together with the analyst develops and implements a corrective and preventive action plan. •
•
&ailure investigations are completed within ' $ working days.
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Master Plan Page #6 of (# )ocument *umber+ M-## er. -.xx Laboratory Compliance oot Cause nalysis an# Correcti'e an# Pre'enti'e ction Plans The Laboratory continually revises and improves processes if necessary. &ailure investigations and evaluation of ""! results are one way to identify problems. "ther sources are customer complaints, internal and external inspection findings and problems identified in management reviews. The Laboratory has a formal :/P/ program that follows the !"P !--3 B0ef. '$.3C. Gecause of its close connection to testing, ""! results and 0:/ and :/P/ failure investigations are discussed in the chapter Duality of Test 0esultsE, although 0:/ and :/P/ may not only be initiated through ""! test results as explained above. &ollowing the !"P !--3 ensures+ •
Problems are clearly identified and described.
Problems are evaluated and the magnitude and impact is evaluated through a formal risk assessment. •
•
The investigation of the problem follows a documented plan.
The source of the problem is identified through a formal root cause analysis. •
/n action plan is developed with a list of re4uired tasks, time schedule and owners. •
/ team is formed to implement the plan. The team may be cross functional if appropriate. &or example, the local or corporate IT department may get involved to find the root cause of a problem associated with a computer system. •
•
/fter implementation, the effectiveness of the actions is verified.
)ata e'iew an# 6ali#ation
1xplained in !"P !6>- B0ef. '$.3C. The analyst generating the analytical data has the primary responsibility for data correctness and completeness. If critical data are transcribed from a paperbased system into an electronic data management system, a second analyst verifies accuracy of entries. •
The primary analyst is responsible for assembling the data package containing all relevant raw data needed for data interpretation and validation for each batch of sample processed. / data package typically includes+ 4uantitative analysis reports, a list of instrument parameters, chromatograms and log files. •
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Master Plan Page #> of (# )ocument *umber+ M-## er. -.xx Laboratory Compliance The Laboratory supervisor or his%her designee reviews and approves all data for a given sample before it is released. This review assures that results from different parameters for a given sample correlate. •
/s the last step the / officer or his%her designee reviews the data, releases the test result and the final report is issued. •
The information to be reviewed depends on the test and for chromatography typically includes+ :onformance of test results to written specifications. Information on sampling and test method. Information on compound identity and strength. :ompleteness of the report header. The initials or signature of the person who performed the test and the dateBsC the tests were performed. :ompleteness of supporting material, e.g., chromatograms. :riteria for calibration, retention and time windows. Proper documentation of manual integration results. :omplete records of any modification of a method employed in testing. /ll calculations performed in connection with the test, including units of measure, conversion factors and e4uivalency factors. uality control or system suitability data. )ocumentation of irregularities. •
− − − − −
− − − −
−
− −
eportin !est esults
&or reporting test results The Laboratory follows the procedure in !"P !6>' B0ef. '$.3C to ensure consistent and compliant reporting. 0esults are reviewed to address accuracy, clarity and ob7ectivity. )ata in the test report include+ •
0eference to established test method and sample preparation procedure.
•
)eviations, additions to, or exclusions from the test method.
•
/ statement of conformance or nonconformance with specifications.
•
*ame of analyst.
•
*ame of first and second reviewer.
If data on the final report needs to be revised after it has been released a 7ustification must be added.
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Master Plan )ocument *umber+ M-## er. -.xx Laboratory Compliance 0elated !"P H 0eference '$.3
Page #9 of (#
!--3+ :orrective and Preventive /ctions !--(+ 8andling "utof!pecification 0esults !(-'K 0eview and /pproval of /nalytical Test 0esults !(#$+ Laboratory &ailure Investigations !6'-+ "ngoing Performance :ontrol of /nalytical 14uipment !6>'+ 0eporting of /nalytical Test 0esults for &)/ and I!" ->$'( :ompliance
15. "#entification an# Manaement of ecor#s 0ecords are identified, maintained and archived following the !"Ps !#-3 and !#-( B0ef. '$.3C. &ollowing the !"Ps ensures+ 0ecords are identifiable to the company, product, person or event to which they pertain. •
•
0ecords are dated and identify the person who established the records.
•
1ntries on paper records are made in ink.
:orrections to paper records do not erase the original entry. :hanges include the correct information, the initials of the person who made the change and the date. •
The definition of raw data follows the &)/As riskbased approach for Part --. The Laboratory follows !"P !-#> B0ef. '$.3C. •
/vailability of electronic records in case of system problems or human errors is ensured through a regular backup. Gackup and restore of electronic records follow !"P !#-> B0ef. '$.3C. •
•
0ecords are kept confidential through limited and authori@ed access.
•
0ecords are stored in a dry and clean room.
Type of records to be archived and the archiving period is defined. / form for identification is included in /ttachment '-.;. •
0ecords will be retained for at least as long as re4uired by regulations. 1xact retention periods of records are defined by corporate policy for each record type. •
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Master Plan Page #; of (# )ocument *umber+ M-## er. -.xx Laboratory Compliance /ll records re4uired by the &)/ and e4uivalent international regulations, or copies of such records are readily available for authori@ed inspection during the retention period at The Laboratory where the activities described have been recorded. 0ecords that are stored at another location can be immediately retrieved from the other location by computer or other electronic means. •
0ecords are retained either as original records or as true copies such as photocopies, scanned to electronic files, microfilm, microfiche or other accurate reproductions of the original records.
&or maintenance and archiving of electronic records, The Laboratory follows the !"P !#-( B0ef. '$.3C. •
0elated !"P H 0eference '$.3 !-#>+ '- :&0 Part -- H !cope and :ontrols !#-3+ 0ecord and )ata Identification and Management !#-(+ 0etention and /rchiving of 1lectronic 0ecords !#-6+ !canning of Paper 0ecords for ?xP :ompliant /rchiving !#->+ )ata Gackup and 0estore
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Master Plan )ocument *umber+ M-## er. -.xx Laboratory Compliance
Page 3$ of (#
20. eferences This chapter lists the documents that are available to assist in implementing the master plan. Primers an# Master Plans
-. 0isk Management Master Plan. 1xample included in the Labcompliance Laboratory :ompliance Package+ www.labcompliance.com%books%labcompliance. '. 14uipment ualification Master Plan. 1xample included in the Labcompliance Laboratory :ompliance Package+ www.labcompliance.com%books%labcompliance. #. :omputer !ystem alidation Master Plan. 1xample included in the Labcompliance :omputer !ystem alidation Package+ www.labcompliance.com%books%computers. 3. *etwork ualification Master Plan. (. '- :&0 Part -- :ompliance Master Plan. 1xample included in the Labcompliance Part -- :ompliance Package+ www.labcompliance.com%books%part--. 6. Training Master Plan. >. :alibration and Preventive Maintenance Master Plan. 9. ?ood /utomated Manufacturing Practice, ?uide for alidation of /utomated !ystems in Pharmaceutical Manufacture, ersion #, March -;;9, ersion 3, )ecember '$$- www.ispe.org. ;. Primer, &)/%1= :ompliance in /nalytical Laboratories. 1xample included in the Labcompliance Laboratory :ompliance Package+ www.labcompliance.com%books%labcompliance. -$. Primer, :omputer !ystem alidation, Labcompliance, '$$(, 3$ pages. 1xample included in the Labcompliance :omputer !ystem alidation Package+ www.labcompliance.com%books%computers . eference Publications
/ll are included in the Laboratory :ompliance Package from Labcompliance+ www.labcompliance.com%books%labcompliance. -. /-'#+ :/P/ H / &undamental uality !ubsystem. www.labcompliance.com (Replace with your company’s name) !E
FOR INTERNAL
Master Plan Page 3- of (# )ocument *umber+ M-## er. -.xx Laboratory Compliance '. /-''+ Preventing "utof!pecification B""!C !ituations :aused by Laboratory 1rrors. #. /-(3+ )efinitions+ ualification vs. erification, :alibration and alidation. 3. /-63+ ualification of 14uipment and :omputeri@ed !ystems. (. /-9#+ Implementing '-:&0 Part -- in Laboratories. 6. /-99+ '- :&0 Part -- :ompliance for Pharmaceutical Laboratories+ / !uppliers Perspective. >. /-;3+ Implementing '-:&0 Part --+ )ata Migration and Long Term /rchiving for 0eady 0etrieval. 9. /'#3+ 14uipment ualification in Practice. ;. /'#;+ !electing Parameters and Limits for 14uipment "perational ualification. -$. /'>#+ 0iskGased alidation of :ommercial "ffthe!helf :omputer !ystems. --. /'63+ BLaboratoryC 14uipment ualification and :omputer !ystem alidation. -'. /((#+ ualification of 8ighPerformance Li4uid :hromatography !ystems. -#. /6$#+ alidation of /nalytical Methods+ 0eview and !trategy. -3. /6$(+ alidation of 8PL: Methods. -(. /6$>+ 1valuation and alidation of !tandard Methods. -6. /6##+ Preparation and ualification of :ertified 0eference Material and . M-##+ Laboratory :ompliance Master Plan. -9. M6-$+ -$$ Most &re4uently /sked uestions and /nswers 0elated to Laboratory :ompliance. u#io Seminars
-. &)/%1= :ompliance in /nalytical Laboratories B-#(C. Included in the Laboratory :ompliance Package from Labcompliance+ www.labcompliance.com%books%labcompliance. '. alidation of !oftware and :omputer !ystems in /nalytical Laboratories B--'C. #. alidation of :omputeri@ed Laboratory !ystems B-$6C. Implementing the new ?/MP Laboratory !ystems ?uide. www.labcompliance.com (Replace with your company’s name) !E
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Master Plan )ocument *umber+ M-## er. -.xx Laboratory Compliance 3. Laboratory 14uipment ualification B--3C.
Page 3' of (#
(. . /nalytical Instrument ualification B/IC B-#'C. =nderstanding the *ew =!P )raft ?uidance -$(9N. 9. &)/ :ompliant 1lectronic 0ecords Management B-#3C+ http+%%www.labcompliance.com%seminars%audio-#3%index.htm. ;. /udits of :omputer !ystems in Laboratories and Manufacturing B--6C+ http+%%www.labcompliance.com%seminars%audio--6%index.htm. -$. Inspection of Pharmaceutical uality :ontrol Laboratories B-#;C+ http+%%www.labcompliance.com%seminars%audio-#;%index.htm. Stan#ar# %peratin Proce#ures
!"Ps indicated with BOC are included in the Laboratory :ompliance Package from Labcompliance+ www.labcompliance.com%books%labcompliance. -. !-$(+ )ocument :ontrol and Management. '. !--3+ :orrective and Preventive /ctions. BOC #. !--(+ 8andling "utof!pecification 0esults. BOC 3. !-'(+ Training for ?xP, '- :&0 Part -- and :omputer alidation. BOC (. !-#>+ '- :&0 Part -- !cope and :ontrols. BOC 6. !-3-+ &)/ Inspections Preparation, :onduct, &ollowup. BOC >. !-3'+ Multinational ?MP Inspections+ Preparation, :onduct and &ollowup BOC 9. !-(-+ &acilities and 1nvironmental :onditions. ;. !'3$+ ualification of 14uipment. BOC -$. !'(;+ :onfiguration Management and ersion :ontrol of !oftware. BOC --. !'6-+ 0etirement of :omputer !ystems. BOC -'. !'6'+ :hange :ontrol of !oftware and :omputer !ystems. BOC -#. !'6#+ alidation of Macro Programs and other /pplication !oftware. BOC -3. !'66+ )evelopment and =se of !preadsheets in Part -- and ?xP 1nvironments. BOC www.labcompliance.com (Replace with your company’s name) !E
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Master Plan Page 3# of (# )ocument *umber+ M-## er. -.xx Laboratory Compliance -(. !'6>+ alidation of 1lectronic Laboratory *otebooks. BOC -6. !'69+ =sing 1lectronic Laboratory *otebooks in an &)/ 0egulated 1nvironment. BOC ->. !'>$+ alidation of 1lectronic )ocument Management !ystems. BOC -9. !'>-+ alidation of :ommercial "fftheshelf B:"T!C :omputer !ystems BOC. -;. !'>'+ /uditing :omputer !ystems. BOC '$. !'>#+ /uditing !oftware !uppliers+ Preparation, :onduct, &ollow up. BOC '-. !'>3+ uality /ssessment of !oftware and :omputer !ystem !uppliers. BOC ''.!#-3+ 0ecord and )ata Identification and Management. '#. !#-(+ 0etention and /rchiving of 1lectronic 0ecords. BOC '3. !#-6+ !canning of Paper 0ecords for ?xP :ompliant /rchiving. BOC '(.!#->+ )ata Gackup and 0estore. BOC '6. !#'-+ irus :hecks of IT !ystems. '>. !($3+ ?eneration and Maintenance of !"Ps for Laboratories. BOC '9. !($;+ :hange :ontrol of /nalytical 14uipment. BOC ';. !(-$+ Laboratory Management 0eview. #$. !(--+ /uditing Laboratory !ystems. #-. !(-#+ Training for Laboratory Personnel. BOC #'. !(-;+ 0isk /ssessment for Laboratory !ystems. BOC ##.!(#$+ Laboratory &ailure Investigations. BOC #3. !(#-+ !ampling for /nalytical Testing. #(.!(#'+ Preparation of :alibration !tandards. #6. !(##+ Measurement Traceability. #>. !(#3+ 8andling of Laboratory Test Items. #9. !(3-+ Maintenance of Laboratory 14uipment. #;. !((-+ !tability Testing. 3$. !6-'+ alidation of /nalytical Methods. 3-. !6-#+ alidation of :hromatographic Methods. BOC 3'. !6-3+ Transfer of /nalytical Methods. 3#. !6'-+ "ngoing Performance :ontrol of /nalytical 14uipment. www.labcompliance.com (Replace with your company’s name) !E
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Master Plan Page 33 of (# )ocument *umber+ M-## er. -.xx Laboratory Compliance 33. !6'9+ )evelopment of =ser 0e4uirement !pecifications for /nalytical 14uipment. BOC 3(. !63-+ :alibration of /nalytical Galances. BOC 36.!633+ ualification of 0efrigerators. BOC 3>. !6(6+ alidation of Laboratory :omputer !ystems. BOC 39. !66'+ 0iskGased alidation of Laboratory :omputer !ystems. BOC 3;. !6>-+ /nalytical )ata 0eview and alidation. ($. !6>'+ 0eporting of /nalytical Test 0esults. ) an# "nternational eulations$ >ui#elines an# Pres entations
)ocuments or links included in the Laboratory :ompliance Master Plan+ www.labcompliance.com%books%labcompliance. -. ?uidance for Inspectors and other &)/ Personnel ?uide to Inspection of Microbiological Pharmaceutical uality :ontrol Laboratories. '. ?uidance for Inspectors and other &)/ Personnel ?uide to Inspection of Pharmaceutical uality :ontrol Laboratories . #. PI:%! /ide Memoire+ Inspection of Pharmaceutical uality :ontrol Laboratories. 3. &)/ '- :&0 '-:urrent ?ood Manufacturing Practice for &inished Pharmaceuticals . (. ?uidance for Inspectors )rug Manufacturing Inspections . 6. '- :&0 -1lectronic 0ecords H 1lectronic !ignatures . >. ?uidance for Industry '- :&0 Part --K 1lectronic 0ecordsK 1lectronic !ignatures, !cope and /pplications . 9. ?uidance for Industry BdraftC Mass !pectrometry for :onfirmation of the Identity of /nimal )rug 0esidues. ;. ?uidance for Industry BdraftC /nalytical Procedures and Methods alidation . -$.?uidance for Industry Gioanalytical Method alidation .
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Master Plan Page 3( of (# )ocument *umber+ M-## er. -.xx Laboratory Compliance --. &)/ ?uidance 0e4uesting Methods alidation for /bbreviated *ew )rug /pplications B/*)/sC. -'.&)/ Industry ?uidance Investigating "utof!pecification B""!C Test 0esults for Pharmaceutical Production. -#.?uidance for Industry ?eneral Principles of !oftware alidation . -3. /nnex -- of 1= ?MP :omputeri@ed !ystems. 9ors(eets$ C(eclists$ orms$ !emplates$ 3;amples
/ll included in the Laboratory :ompliance Package from Labcompliance+ www.labcompliance.com%books%labcompliance. -. 1-93+ . 1#''+ Template%1xamples+ :omputer !ystem Identification.
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Master Plan )ocument *umber+ M-## er. -.xx Laboratory Compliance
Page 36 of (#
21. ttac(ments Laboratory Personnel
This is a template to document laboratory personnel with name, position%title, education level and years of experience.
Name
Position
3#ucation
?ears of 3;perience total@current
)ocument Master List
This is a template to list controlled documents with document id, description, owner and status.
)ocument ") ANumber$ e'B
Copies )istribute#
)escription
Location
!'## er. -.$
!"P+ ualification of /nalytical Instruments
: Lab
2an $3, '$$(
)ec -(, '$$(
6
1#6' er. #.$
0e4uirement !pecifications for 1xcel
: Lab
2ul '#, '$$(
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)ate of Last e'iew
)ate of "ssue or e'ision
FOR INTERNAL
Master Plan Page 3> of (# )ocument *umber+ M-## er. -.xx Laboratory Compliance !emplate an# 3;ample to )ocument !rainin e7uirements 1mployee+ !upervisor+ )epartment+ )ate+ 2ob )escription+ /ssigned Tasks+ e7uire# -ualification
=nderstands re4uirements of '- :&0 Part --.
3#ucation$ Pre'ious 3;perience or !rainin Courses /ttended # day training course on '- :&0 Part --. :ertificate available.
www.labcompliance.com (Replace with your company’s name) !E
A##itionalB !rainin e7uire#
Qes $
*o $
Qes $
*o $
Qes $
*o $
Qes $
*o $
Qes $
*o $
FOR INTERNAL
Master Plan )ocument *umber+ M-## er. -.xx Laboratory Compliance
Page 39 of (#
!emplate to )ocument !rainin
1mployee+ !upervisor+ )epartment+ )ate+ Training !ub7ect+ Training "b7ective+ Type of Training+
1.g. classroom
Location+ )ate+ )uration B)aysC+ ualified Trainer+ :ertificate /vailable+ Training "b7ective Met+
Qes $
*o $
2udged Gy+
1.g. certificate or through personal examination by the supervisor.
If "b7ective *ot Met 1xplain
5555555555 555555 5555555555555 *ame
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)ate
!ignature
FOR INTERNAL
Master Plan )ocument *umber+ M-## er. -.xx Laboratory Compliance
Page 3; of (#
37uipment List
This is a template to document the available e4uipment in the lab . 37uipment ")
)escription
Manufacturer
Location
www.labcompliance.com (Replace with your company’s name) !E
)ate of "nstallation
-ualification Status
FOR INTERNAL
Master Plan )ocument *umber+ M-## er. -.xx Laboratory Compliance
Page ($ of (#
List wit( ut(ori/e# =sers of 37uipment
14uipment I)+ )escription+ )ate
Name of =ser
unction
www.labcompliance.com (Replace with your company’s name) !E
Sinature
FOR INTERNAL
Master Plan )ocument *umber+ M-## er. -.xx Laboratory Compliance
Page (- of (#
37uipment ecor#s
This is a template to record e4uipment events such as calibrations, BreC4ualification, performance checks, modifications, updates, damages, malfunctions and repairs.
14uipment I)+ !erial *umber+ )escription+ Location+ Installation )ate+ )ate
3'ent cti'ity
www.labcompliance.com (Replace with your company’s name) !E
esponsible Person
Sinature
FOR INTERNAL
Master Plan )ocument *umber+ M-## er. -.xx Laboratory Compliance
Page (' of (#
ecor#in Samplin )ata
!ampling Location+ !ampling 14uipment+ !ampling Procedure+ )ate
3n'ironmental Con#itions
%bser'ations
Person
List of ecor#s to be rc(i'e# ecor# "#entifier
)escription
Storae Me#ia
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Storae Location
rc(i'in Perio#
FOR INTERNAL
