Sample Quality Manual for Laboratories

Sample Sample Quality Q uality policy manual manual for Laboratories Aravindsai ravi ndsai Nagubandi N agubandi www.pharmacygraduates.org [email protected]

Quality Systems Policy Manual This doc d ocum ument ent contai co ntains ns the poli p olicies cies and reference reference procedures proc edures followed followed the laboratory laboratory to ensure that that the study s tudy is is conducted co nducted in in accord acc ordance ance with with OECD OEC D GLP guideli guidelines nes

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Contents ..........................................................................................................................................................1

1.

Terms and definitions ..................................................................................................................3

2.

Proc Pr ocedures edures referenced referenced in the Manual ............................................................................................4

3.

Quality policy .............................................................................................................................4

4.

Roles Roles and responsibilit responsibilit ies .............................................................................................................5

5.

Facility .......................................................................................................................................6

6.

Apparatus, materials and reagents.................................................................................................6

7.

Test systems................................................................................................................................7

8.

Test and reference re ference items ..............................................................................................................7

9.

Standard operating procedures ......................................................................................................7

10. 10.

Perfo Pe rformance rmance of study study ...............................................................................................................8

11. 11.

Reporting of study results .........................................................................................................9

12. 12.

Storage and a nd retention retention of Records Rec ords and mate material rialss ..........................................................................9

SOP OO8: Handling of test system individuals found moribund or dead during the study.


..................... 10

1. Terms and definitions (OECD (OEC D Principles Principles of Good Good Labo Laboratory ratory Practi Pra ctice) ce)

Term

Definition

Test facility

Persons, Per sons, prem pre mises and a nd operat op eratiional unit(s) unit(s) that is necessary nece ssary for Conducting Co nducting the non-clinica non- clinicall health and environ environmen menta tall safety study. For multi-s ulti-siite studies, studies, those which which are conducted at more more than one site, the test facili facilitt y compri co mprises ses the site site at which which the Study Director is loc locate ated d and all individua individuall test sites, which ind ind ividua vid ually lly or collectivel collectivel y can be considered considered to be test test facili facilities ties Means the loca locati tion(s) on(s) at which which a phase(s) of a study is conducted.

Test site Test facility management Sponsor

Study Director Standard Operating Procedures Master schedule Raw data

person(s) pe rson(s) who has has the authority authority and formal formal Responsibil Resp onsibiliit y for the organizat organizatio ion n and function functionii ng of the test facility acility accordin acco rding g to these these Principles Principles of Good Laboratory Laborato ry Practice. Entity Entity which commissio commissio ns, supports suppo rts and/or and/o r submits submits a non-cli non- clinic nicaa l health and environ environme menta ntall safety study Indivi Individ ual ua l responsible resp onsible for the overall overa ll conduct co nduct of the nonclinical nonclinica l health and environ environme menta ntall safety study Documented Documented procedures proc edures which which descri desc ribe be how to perform tests or activit activit ies normally not specif spe cifiied in detail de tail in in study plans or test guidelines. Compi Co mpilatio lation n of infor nform matio at ion n to assist in the the assessment asse ssment of o f workload work load and for for the tracking trac king of studies at a test facility. all origina originall test facilit facilit y record rec ordss and documentatio do cumentation, n, or verified verified copies co pies there thereof, of, which which are a re the result of the origina originall observations ob servations and activit activit ies in a study. Raw data also may may inclu includ d e, for example, photographs, microfilm crofil m or o r microfic he copi cop ies, computer readabl readab le media, di d ictated observati obse rvations, ons, recorded record ed data from automated automated instrume nstrume nts, or any other data storage mediu medium m that has has been b een recognized recognized as capabl capab le of providing providing secure storage of infor nform ma tion tio n for a time time .


2. Procedures referenced in the Manual

Procedures Proce dures (OECD Princi Princip p les of Good Laboratory Practice)

Referred as

Receipt, identification, labeling, handling, sampling sampling and storage of test and reference reference items.

SOP 001

Use, maintena aintena nce, cleaning cleaning and calibrat calibratiio n of apparatus.

SOP 002

Labeling Labeling for for materials, aterials, reagent rea gentss and and soluti solutions. ons.

SOP SO P 004

Codin Co ding g of studies, studies, data coll collection, preparation prep aration of reports rep orts,, indexing indexing systems, handling hand ling of o f data, da ta, includin including g the use of computerized systems.

SOP 005

Room preparati prepa ration on and a nd environme environme ntal room conditi co ndition onss for the test system. system.

SOP 006

Procedures for receipt, transfer, proper placement, characterization, identification and care of the test system. Handling of test system individ individuals uals foun found d moribund mori bund or dead durin during g the study study.. Test system system preparation, observati o bservations ons and exami examinati nat io ns, before, during during and at the conclu co nclusion sion of the the study. Collection, identification and handling of specimens including necropsy and histopathology Siting Siting and place placement ment of test systems in test plots.

SOP 007

Operat Op eratiion of Quality Quality Assurance personnel pe rsonnel in planning, scheduling , performing, docum doc umenting enting and reporti repo rting ng inspec inspecti tio o ns

SOP 012

SOP 008 SOP 009

SOP 010

SOP 011

3. Quality policy

3.1. 3. 1. The test facility facility is committed committed to assure that the studies bein be ing g performed p erformed under unde r this laboratory abo ratory are in com co mpliance pliance with with OECD O ECD principl principlee s of Good labo laboratory ratory practices. p ractices.


Procedures Proc edures are developed to achieve achieve this, this, all the the deviati deviatio o ns from the procedures proce dures are invest nvestigated igated and corrected. correc ted.

4. Role Roless and res pon ponsibil sibilities ities

ROLE Lab Manager.

RESPONSIBILITIES 

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Study Director

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Quality assurance manager

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Ensures compli c ompliance ance with with the Princip Princip le s of Good Goo d Laborato Labo ratory ry Practice Pra ctice within within the test facility. facility. Maintains sufficient number of qualified personnel. Maintains Maintains docum doc uments ents and a nd Masters Schedule/ Schedule/ ensures proper prope r documentatio do cumentation n is mainta maintained. ined. Arranges training trainingss for personnel pe rsonnel and mainta maintains ins training evaluation records. Manages archiv a rchiving ing record rec ords/ s/ appoin appo ints ts an individual ndivid ual to manage archiving records.

Overall Over all conduct cond uct of the study and fina finall report. rep ort. Approves the study plan and its amendments Maintains effective communication with Quality assurance perso p ersonnel nnel and assures that they have Inform/ Inform/ train the personnel perso nnel with the changes changes in the study plan plan and procedures. Ensure that data integrity integrity is mainta maintained ined between be tween raw data dat a and reports. Ensure Validat Validation ion and calibra calibratio tion n of o f requi req uired red equi eq uipment’s pment’s and computer co mputer systems. syste ms. Ensure that the study is conducted in accordance with the appl app licabl cab le Principles Principles of Good Laboratory Practi Prac tice. ce. Maintain copies co pies of all appro ap proved ved study plans and Standard Sta ndard Operatin Op erating g Procedures Proc edures and up to date master master schedule. schedule. Conduct Co nduct study, facility facility and proces pro cesss inspe inspectio ctions ns to verify verify the study is bei be ing conducted co nducted on GLP princip princip les and mainta maintain in the records of inspection.

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Chemists

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Compl Co mply y with the instruct instructiio ns given given in standard standa rd ope o perating rating procedures and study plan. Comm Co mmunica unicate te devi de viations ations from the proced pro cedures ures with with the the study director

5. Facility

5.1. 5. 1.The The test facility facility is of suitab suitablle size, size, constructio c onstruction n and location oc ation to meeting requi req uireme rements nts of the study and to minimiz minimizee disturbance that would would interfere with the the validit validity y of the study. 5.2. 5. 2.Uni Univers versity ity is comm co mmiit ted to provi pro vide de if any additi ad ditiona onall req r equi uireme rements, nts, if needed need ed in in the future, future, There are a numbe numberr of empty rooms roo ms that that would be suitab suitable le for the housin housing g of other othe r small ani a nimals. mals. 5.3. 5. 3.The The uni univers versity ity has an anima anima l house in in a facility, facility, with with its own Manager, three anima anima l techni tec hnicc ia ns, and a consul co nsultt ing Veterinarian. Veterinar ian. The only species spe cies of animals animals housed there at the moment moment are rats. 5.4.There 5.4 .There are separate partiti partitio ns in the the laboratory which which provide areas a reas for recei rece ipt and storage stora ge of the test and reference items, and mix mixing ing of the test items items with with a vehicle. vehicle. These These areas are as are adequate adeq uate to adequate ade quate to preserve prese rve identity, identity, concentration, concentratio n, purity, purity, and stability, stability, and ensure ensure safe safe storage for hazardo hazardous us substances. 5.5. 5. 5.There There is is an archi arc hiva vall facilit facilit y is mainta maintained ined by the Univers Universit ity's y's Engin Enginee ering er ing Department Depa rtment who are responsible resp onsible for security and for for the maintenanc maintenance. e. ( Importance and consequences: If t he areas are not partitioned, receipt materials may get mixed with storage products, which may end up with giving wrong test article to the test system producing a f alse data. If the archival facil f acility ity is not secured data may be lost lost or stolen, study needs to be done again t o get the t he data, which is a waste w aste of time and money)

6. Apparatus, materials and reagents 6.1.Appa 6.1 .Apparatus ratus are loca located ted in appropri approp riate ate design. design. And their their installio nstallio n is qualified qualified.. 6.2.All 6.2.All the equipmen equipment’s t’s used in in the facil facilit ity y carry car ry a status label which which indicate indicatess the status 002). of calibrati calibrat io n, cleaning status sta tus (ref: SOP 002). 6.3.Equi 6.3.Equipme pment’s nt’s effect effect on the test systems is evaluated with the the help of consul co nsulting ting Veterinarian; Veterinarian; equipment’s equipment’s are used only if they are safe sa fe to be used. 6.4. 6. 4.Only Only labeled reagents rea gents are a re permi pe rmitted tted for use in the the facility (label contains: Identi Ide ntity ty expiry expiry date da te and speci spec ific storage instructions, instructions, Informatio Information n concerning concerning source, preparation pre paration date and stabil stability) ty )

( t he apparatus doesn’t work as installed installed or the Importance and consequences: If the design of room doesn’t suit the equipment functioni funct ioning, ng, the results results obtained from the equipment will no longer be accurate, which means that the research is no t credible credible Even Ev en if the equipment functions properly, and if af fects the safety safety of the animal, due t o the biochemical changes (induced by apparat us but not test article) interferes with the study leading leading to a wrong dat a. Labeling is t o ensure that t hat right right things are given t o right right test systems)


7. Test system sys temss 7.1. 7. 1.All All rats used in laboratory labora tory come c ome from the appro ap proved ved supplier, supplier, Suppli Supp lier er qualifica qualificatio tio n is performed p erformed by b y Quality assurance with the requi req uireme rements nts addre ad dressing ssing study direc director tor and consulting veterinarian. 7.2. 7. 2.When When the anim animals are received rec eived their source, so urce, date of arrival, arrival, and arrival conditi c onditio o ns are recorded record ed and the the documen d ocuments ts are main mainta tained ined by the the QA departm dep artment. ent.(ref: (ref: SOP 007) 7.3. 7. 3.Ne Newl wly y receiv rece ived ed animal animal and plant test systems will will be isolated isolated until their health status sta tus has been be en evaluated evaluated by the consul co nsultin ting g Veteri Veter inari nar ia n. A label indicat indicating ing their status will will be placed placed on their their cage. c age. 7.4. 7. 4.Cleaning Cleaning and maintena maintena nce of anima anima ls is done do ne by the three anima anima l technicians technicia ns at the anima anima l house facili facilitt y and these are monitore monitored d by a nimal nimal house facilit facility y manager. 7.5. 7. 5.Pes Pesti ticides cides used in the anima anima l house ho use are evaluated by veterinaria n (for interfere interference nce with animal animal safety) and study study director (for inf infere erenc ncee in the study).(ref: study).(ref: SOP 006). 7.6.If 7.6.If the the anim anima ls or infected nfected,, dead or diseased the infor nform matio at ion n wil will be recorded record ed immed iate at e ly and ani anima ls are isolated/ disposed so that that they doesn’t doe sn’t affect affect other anima anima ls or qualit qualit y of the study. study. (ref: SOP 008 and SOP 010)

( Importance and consequences: If t he test systems are used ev en before their health status is not ev aluated and if if the animal dies due t o its its health conditions, t hings cannot be achieved on time. Health Health conditions and properly properly monitored m onitored and all the fa ctors which which affects affect s the health of test systems should be monitored so as to decrease the interference with the research / test article.) 8. Tes Testt and refer refe rence items 8.1. 8. 1.When When the test items items are received received they will will be inspe inspecte cted d by the study personnel pers onnel for the label containing their identity (Chemical Abstracts Service Registry Number [CAS num number], name, name, and biologi biologicc a l parameters), expiry expiry date, and quantity quantity and storage 001). They will conditions (Ref: SOP 001). will place p lace in quarantine quara ntine area are a till till the inspe inspectio ction n and approval. 8.2.Aft 8.2 .After er the approval they will will be placed placed in the storage area a rea based base d on their their label instructions (ref: SOP 004). 8.3.Sample 8.3 .Sample retention area is is provided provided in the labo laboratory ratory where the samples samples of o f each batch

are stored. ( Importance and consequences: Inspection and approval is to ensure that right test article is being given t o the test system. If a different product is is given giv en then it it will lead to a different research, t his can lead lead t o waste of time and money)

9. Standard operating procedures 9.1.List 9.1.List of SOP’s 

Receipt, identifica identificatio tion, n, label abe ling, handling, handling, sampling sampling and storage of test and reference items.




Use, maintena aintena nce, cleaning cleaning and calibrat calibratiio n of apparatus. app aratus.

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Vali Validati dat io n, operati ope ration, on, main mainte tenance, nance, security, security, change change control and and back - up of

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computerized systems. Labeli Labe ling ng for materials, materials, reagents rea gents and solution solutions. s.

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Codin Co ding g of studies, studies, data collection, collection, preparati prepa ration on of reports, repo rts, indexing systems, systems, handling of data, da ta, inclu includ d ing the use use of computerized co mputerized systems. Room preparation and envi environme ronme ntal room conditio conditio ns for the test system. system. Procedures Proce dures for for receipt, transf transfer, er, proper prop er placement, placement, characteriza characteriza tion, tio n, identifica dentificatio tion n and care of the the test system. system.

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Test system system preparati prepara tion, on, observati obse rvations ons and exami examinati nat io ns, before, during during and at

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the conclusio conclusio n of the study. Handling of test system system individ ndivid uals ua ls found found moribund or dead during during the study.

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Col Co llection, identifica identifica tion tio n and handling of specim spe cimens ens inclu includ d i ng necrop nec ropsy sy and histopathology Siting Siting and place placement ment of test systems in test plots. plots. Opera Op eration tion of Q uality uality Assurance personnel per sonnel in in planning, schedul sched uling ing , performing, documenting and reporting inspections

9.2.All 9.2 .All the standard operati ope rating ng procedures proce dures and thei theirr revisi revisio o ns are appro ved by test facil facility ity management. 9.3. 9. 3.Only Only the the current versions are a re made availab availab le to personnel per sonnel and a nd the old old versions are a re archived. ( Importance and consequences: Standard operating procedures are to ensure that the policies policies are being carried carried out o ut as required. If there are no procedures av ailable ailable then there th ere is no assurance t hat the policies policies are followed)

10. Perform Performance ance of s tudy

10.1. Study plan plan approved app roved by study director director is checked check ed for GLP compli complia nce by the the QA before b efore ini initiat tiatio ion n of the study study (ref: SOP 012). 10.2. All All the the amendmen amendments ts made are appro ap proved ved by the study director, directo r, indicat indicat ing the justific justific ation at ion of amendment. 10.3. Any deviations deviations from the study plan while while conduct co nduct of o f the study is reported repo rted to study study director directo r who will will be b e assessin asse ssing g the risk risk and manageme management. nt. ( St udy plan is to assure that things are not being Importance and consequences: Study retrospectively done, if the things t hings are retrospective then the data will will not be considered as credible)


11. Reporting of study results

11.1. Final reports repo rts are signed signed by the study director directo r carryi ca rrying ng the accepta acce ptance nce of responsibilit resp onsibility y of o f valid valid ity of o f data. da ta. 11.2. Any corrections corre ctions or changes are made in the form form of amendments indicat indicating ing their reason. ( Importance and consequences: Signatures in the final report indicate the study director assurance of the results obtained, if he doesn’t assure t he study, then the study is not considered as credible) 12. Storage and re re te tention ntion of Record Re cordss and mate materials rials

12.1. All the versions of standard operating procedures except the current versions, historical historical test results, results, environmen environmentt monitor onitoring ing records, record s, vali validati dat io n and maintena aintena nce documents do cuments are a re indexed for easy eas y retrieval and archi arc hived ved (ref: SOP 005). 12.2. Archiva Archiva l room roo m is secured sec ured 24 hours and only the authorized personnel personnel have assess, asse ss, inspe inspecto ctors rs or visitors visitors who are approved appro ved for for entry should be escorted esco rted all a ll time time duri d uring ng their visit visit by the authorized personnel. pe rsonnel. ( easily retrieved, or else Importance and consequences: Archived records should be easily it would tak e a lot lot of time to search f or documents, during the inspections inspections if the t he right documents cannot be prov ided in in right time auditors auditors might feel that the things are not organized)


SOP OO8: Handling Handling of tes t s ys yste tem m ind individuals ividuals found moribu moribund nd or dea dead d dur during ing the study. s tudy. Divi Diviss io n of pharmaceut pharmaceutiical ca l product prod uct development development SAI UNIVERISTY Purpose and Scope : This This is proced pro cedure ure to handle dead de ad and moribund moribund anima anima ls during during the study st udy and this this proc pr oced edure ure applies applies to anima anima l house facility facility manager and technica technicall staff. staff. Responsibility: Techni Tec hnica ca l staff staff of anima anima l house house facility. Date iss ued: 09/10/2010 Date revised revise d: 29/10/2010 Procedures: anima ls are monitore monitored d addressing add ressing the SOP 007 entitled 007 entitled Procedures for receipt, 1. All the anima transfer, proper placement, characterization, identification and care of the test system. 2. If any animals animals are found found moribu moribund nd or dead de ad,, the technica technica l staff should look oo k at the contact co ntact informat informatio ion n sheet s heet and inf inform orm the respec resp ecti tive ve perso p erson. n. Sta ff should should directly report rep ort to the facility facility manager, and if the fac faciility manager 3. Staff 4. If the anima anima ls are found found moribund moribund facilit facilit y manager or techni tec hnicc ia ns should should report rep ort the report rep ort the research resear ch staff and consul co nsultin ting g veterinaria n immediate immediate l y, to allow allow them to resol reso lve the problem pro blem,, al a ll these these communicat communicatio ion n and actions shoul should be recorded. record ed. 5. When When the animal animal is found dea dead d  

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Record as “found “found dead “in the anima anima l’s cage card. card . Place the dead dea d anima anima l in the plastic bag ba g and place it in in the the area are a desig de signated nated,, and report rep ort the the facilit facilit y manager, who is is responsibl resp onsiblee to report to the research rese arch staff. staff. Record Reco rd the the numbe numberr of anima anima ls found found dead de ad at the the cage.

Ded uct the num numbe berr of anima anima ls from the the cage sheet shee t (origi (original na l numbe numberr o f anima anima ls- numbe number r 6. Deduct of dead animals) 7. Clean and sanitize sanitize the cage.

Approve Approved: d: Date:

(study (s tudy dire dire ctor s ignature)

13. 13. References:

OECD OEC D Principl Principlee s of Good Laboratory Practi Pra ctice ce,, 1997 199 7


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