Quality Risk Management Pharm

Quality Risk Management For Pharmaceutical Industry |

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Quality Risk Management For Pharmaceutical Industry Wed, 02/28/ 02/28/2007 2007 - 02:00 — Anony Anonymous mous

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Kirupakar.B.R

The importance of quality systems has been recognized in pharmaceutical industry and the protection of the patient by managing the risk to quality is being given prime importance %

'he manufacturin and use of a dru (roduct has some deree of ris)* It is im(ortant to understand that (roduct +uality should e maintained throuh out the (roduct lifecycle* 'raditionally ris) to +uality ha"e een assessed and manaed in a "ariety of informal ays for e.am(le com(ilation com(ilation of oser"ations, trends and other information* 'hese (ro"ide information that su((ort to(ics li)e handlin of com(laints, +uality defects, de"iations etc* !o ris) manaement can e (erformed ith reconied manaement tools alon ith su((ort of statistical tools in comination, hich ma)e easy for a((lication of +uality ris) manaement (rinci(les* is) 1anaement is a (rocess for identifyin haards associated ith a (roduct, estimatin and e"aluatin the associated ris)s, controllin these ris)s, and monitorin the effecti"eness of the control* An effecti"e +uality ris) manaement ensures the hih +uality of dru (roduct to the (atient* Inaddition +uality ris) manaement im(ro"es decision ma)in if a +uality (rolem arises* It should include systemic (rocesses desinated to co-ordinate, facilitate and im(ro"e scienceased decision-ma)in ith res(ect to ris)* ffecti"e +uality ris) manaement facilitates etter and more informed decisions and (ro"ide 34A reulators ith reater assurance of a com(any5s aility to deal ith (otential ris)* is) manaement (rinci(les are effecti"ely utilied in many areas of usiness and de"elo(ment includin finance, %

insurance, occu(ational safety, (ulic health, (harmaco"iilance and aencies reulatin these industries* It can e a((lied to different as(ect of (harmaceutical +uality includin de"elo(ment, 1anufacturin, 4istriution, Ins(ection, sumission and re"ie (rocesses throuh the life cycle of dru sustances, dru (roduct, ioloical and iotechnoloical (roduct $includin use of ra material,sol"ent,e.cie(ie material,sol"ent,e.cie(ient,(ac)ain nt,(ac)ain  and laelin*& Model for quality risk management is outlined in diagram below.

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4ecision-ma)in nodes are not (resent in diaram ecause decision can occur at any (oint in (rocess* 4ecision miht e to return to (re"ious ste( and see) further information, to ad6ust ris) model or end the ris) manaement (rocess

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Risk Assessment: is) assessment is identification of haards and the analysis and e"aluation of ris) related to ith e.(osure to those haards* As an aid to clearly definin the ris) for ris) assessment fe fundamental are often useful, such as hat miht o ron What is the (roaility and conse+uence of ron occurrence While doin effecti"e ris) assessment, the roustness of the data is im(ortant as it determines the +uality of outcome* 'he ris) assessment can e either +uantitati"e or +ualitati"e (arameter*

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Risk Management Methods and Tools: Basic risk management facilitation methods: 'he sim(le techni+ue used to structure ris) manaement y oraniin data and facilitatin decision-ma)in are flo charts, chec) sheet, (rocess ma((in, cause and effect diarams*

Failure Mode Effects Analysis (FMEA): 31A de(ends on (roduct and (rocess understandin* It methodically rea)s don the analysis of com(le. (rocesses into manaealeste(s* It (ro"ides e"aluation of (otential failure modes for (rocesses and their li)ely effect on (roduct 2

(erformance* It can e a((lied to e+ui(ment and facilities and miht e used to analye a manufacturin o(eration and its effect on (roduct or (rocess* 'his tool is further ad"anced ith studyin criticality of the conse+uences and (ro"idin clear indication of situation* 'he (ur(ose, terminoloy and other details can "ary accordin to ty(e $ 4esin 31A, ealth 31A etc*&, the asic methodoloy is similar for all*

e.g.

Process 31A,

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Benefits of FMEA 9ome enefits of (erformin 31A analysis include hiher reliaility, etter +uality, increased safety and its contriution toards cost sa"in includes decreased de"elo(ment time and reduced aste and non "alue added o(erations*

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;ost enefits associated ith 31A are usually e.(ected to come from the aility to identify failure modes earlier in the (rocess, hen they are less e.(ensi"e to address* 3inancial enefits are also deri"ed from the desin im(ro"ements that 31A is e.(ected to facilitate, includin reduced arranty costs, increased sales throuh enhanced customer satisfaction, etc*

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'his Pro"ides a learnin tool for ne enineers and meets customer re+uirement and/or to com(ly ith 9afety and =uality re+uirements, such as I9> ?00%, =9 ?000, I9>/'9 %@??, 9i. 9ima, 34A ood 1anufacturin Practices $1Ps&, Process 9afety 1anaement Act $P91&

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Ideally, 31A is est done in con6unction ith or soon after PA efforts* esults can e used to identify hih-"ulneraility elements and to uide resource de(loyment for est enefit* An 31A can e done anytime in the system lifetime, from initial desin onard* 'he elo i"en chart % descries the (attern of this tool in the maintenance a((lications and chart II ser"es as a ty(ical e.am(le for (rolem cause durin e.(ort of the finished (roducts and its li)ely effect on the usiness* Cart ! "ailure Mode And #ffe$ts Analysis %"mea& 'ubsystem()ame: 4; motor

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Failure Mode, Effects and Criticality Analysis (FMECA): It is the e.tension of earlier said 31A tool* .tendin 31A to incor(orate an in"estiation of the deree of se"erity of conse+uences, their (roailities of occurrence and their detectaility is 3ailure mode, effects and criticality analysis*

2

In

31;A, each failure mode of the (roduct is identified and then e"aluated for criticality* 'his criticality is then translated into a ris), and if this le"el of ris) is not acce(tale, correcti"e action must e ta)en* 'his can e utilied for failure and ris) associated ith manufacturin (rocesses* 'he tool can also e used to estalish and o(timie maintenance (lans for re(airale systems and/or contriute to control (lans and other +uality assurance (rocedures* In addition, an 31A or 31;A is often re+uired to com(ly ith safety and +uality re+uirements, such as I9> ?00%, =9 ?000, I9>/'9 %@??, 9i. 9ima, 34A ood 1anufacturin Practices $1Ps&, Process 9afety 1anaement Act $P91&, etc*

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When e (erform a 31;A, e are identifyin all (otential failure modes and their associated effects* 'o ma)e this tas) more manaeale, e must first decide hat ty(e of 31;A e ant to (erform - 4esin, Process, Fser, 9oftare, 'est, to name a fe*

Severity classification 'his classification is assined to (ro"ide a +ualitati"e measure of the orst (otential conse+uences resultin from desin error or item failure* ;lassifications should e assined to each identified failure mode and each item analyed in accordance ith the loss statements elo* It may not e (ossile to identify an item or a failure mode accordin to the loss statements in the four cateories elo, ut similar loss statements ased on "arious in(uts and out(uts can e


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de"elo(ed and included in the round rules for the 31;A acti"ity* 9e"erity classification cateories that are consistent ith are defined as follos: ;ateory IG;atastro(hic—A failure that may cause in6ury or death* ;ateory IIG;ritical—A failure hich may cause se"ere in6ury, ma6or (ro(erty damae, or ma6or system damae that ill result in ma6or dontime or (roduction loss* ;ateory IIIG1arinal—A failure hich may cause minor in6ury, minor (ro(erty damae, or minor system damae hich ill result in delay or loss of system a"ailaility or deradation* ;ateory IDG1inor—A failure not serious enouh to cause in6ury, (ro(erty damae or system damae, ut ill result in unscheduled maintenance or re(air*

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31;AHs are similar to 3'AHs* 'he i difference is an 3'A starts ith one s(ecific failure effec t and then identifies only those failure modes that can cause the (articular effect, hereas a 31;A is tryin to identifyin all (ossile failure modes of a (roduct and the effects of these failure modes*

Fault tree analysis (FTA): 'his tool assumes failure of the functionality of a (roduct or (rocess*

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'he results are re(resented (ictorially in the form

of a tree of fault modes* 'his can e used to in"estiate com(laints or de"iation in order to fully understand their root %

cause and ensure that intended im(ro"ement ill resol"e the issues and not cause any other different (rolem* A ood e.am(le of this tool is (ro"ided in the (icture elo* "ault 0ree Analysis

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Hazard Analysis and critical control points (HACCP): HACCP is a systematic, proactive and preventive tool for assuring quality, reliability and safety.

8

It involves hazard

analysis, determining critical control point, establishing critical limit, establishing a system to monitor critical control point and establishing a record eeping system. chemical and biological hazards.

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"his might be used to identify and manage ris associated #ith phys ical,

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Hazard operability Analysis (HAZOP): HA$%P is a highly structured hazards identification tool.

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"his is based on assumption that events are caused by deviations from the design or operating intentions.

!'

(uide #ords

lie for e)ample no, more, o ther than are applied to relevant parameter *eg.contamination, temperature+ to identify potential deviation from the design intentions.

!

or e)ample, #hen the guide #ord -o- is combined #ith the parameter

-flo#- the deviation -no flo# - results. It concentrates on identifying both hazards as #ell as operability problems. /hile the HA$%P study is designed to identify hazards through a systematic approach, more than 8'0 of study recommendations are operability problems and are not, of themselves, hazards. Although hazard identification is the main focus, operability problems should be identified to the e)tent that they have the potential to lead to process hazards, result in an environmental violation or have a negative impact on profitability. "he purpose and scope of the study should be determined before a HA$%P 1tudy ob2ectives may be to chec t he safety of the design, decide #hether and #here to build, chec operating and safety procedures, improve the safety of an e)isting and or modified facility, and verify that safety instrumentation is #oring optimally

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HA$%P 3ethodology includes collection of doc ument and dra#ing, breaing facility into manageable section, listing out parameters, create deviations, record cause and consequence for each cause, record co ntrols to prevent the cause and list any future action that should be implemented.

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It is imperative that accurate information associated #ith the pro2ect is sourced and included in the study. 1uch information may include provisional layouts,material safety d ata sheets *3141+,process flo# diagrams, plant model, equipment arrangement dra#ings, provisional operating instructions,

heat and material balances layouts, logic

diagrams, equipment datasheets, hazardous area layouts, and start5up and emergency shutdo#n procedures.

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"he operation of this tool is depicted in the above diagram.

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Preliminary hazard Analysis (PHA): "his tool analysis is based on applying prior e)perience or no#ledge of hazard to identify future hazards, hazardous situation. "his can be used for product, process and facility design. "his can be used in early development of a pro2ect #here there is little information on detail is available.

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Preliminary hazard analysis *PHA+ is a semi5quantitative analysis that is performed to Identify all potential hazards and accidental events that may lead to an accident, 7an the identified accidental events according to their 1everity and Identify required hazard controls and follo#5up actions. A typical PHA worksheet is shown below.

!

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Risk ranking and filtering: "his can be used to prioritize manufacturing sites for inspection. It is helpful in situation in #hich portfolio of riss a nd the underlying consequences to be managed are diverse and difficult to compare using a tool.

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1tatistical tool lie histograms, control charts or Pareto c harts can aid and facilitate in decision5maing along #ith above5 mentioned tools.

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References: !.(uidance for industry 9 :& :uality ris management; by <1 department of Health and Human 1ervices, ood and drug Administration, Center for drug and ev aluation research =une ''>. . I?C >'8! Analysis techniques for system reliability@Procedure for failure mode and effects analysis *3?A+. . 3?A and 3?CA An %vervie# of Basic Concepts and 4irectory of %ther 7esources by #eibull.com


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F.7eliasoft corporationsG )fmea applications and benefits E.ailure mode effect analysis :uality training and management by (eoff vorely > may !&&& >.I?C >!'E ault tree analysis *"A+. 6.7is Assessment
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simplified ris analysis solutions

!'. I?C >!88 5 Hazard %perability Analysis *HA$%P+. !!. C1I7% minerals %H1K? Intranet !. Preliminary Hazard Analysis by 3arvin 7ausand 1ystem 7eliability "heory *nd ed+, /iley, ''F !. "he Complete (uide to the C7?by Bryan 4odsonand 4ennis olan, L !&&> by :uality Publishing

About Author

Mr.Kirupakar .B.R earned his master degree on Pharmaceutics in ''' at the 47.3(7 medical
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Quality Risk Management Pharm

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