Co rr rre ect ctii ve r re rect v e an d Pre reve vent nti iive ve Actt io ions ns ntiv e Ac “A Five Step Approach” Tonya White-Salters
Tonya White-Salters
Topics to Be Covered • What is CAPA? • Governing authority • Five steps to a good CAPA process • Where companies have difficulty • Example citations • Recap… Tonya White-Salters
Wh at Is CA PA ? • Corrective Action
eliminate detected nonconformity
• Preventive Action prevent
nonconformity occurrence
Tonya White-Salters
CA PA Pr o c es s Map Deviations/OOS/Failure Pro robl ble em Occ ccur urs s Det er mi min n e Ro o t Cau Cau s e Determi termine ne Cor orrecti rective ve Ac Acti tion on Ini niti tia ate CAR CAR Tonya White-Salters
CA PA Pr o c es s Map CA R Res p o n d ent nt((s ) an d Ap A p p r o v er er(s (s)) Deter Det erm m i n ed Resp spon ondent( dent(s) s) Pro Provi vides des Corre Corr ect ctiv ive e Resp spo o n s es , Ro o t Cau Cau s e Veri rifi ficati cation on,, and Imp mpleme lement nt Due Dates Response(s) Summarized Tonya White-Salters
CA PA Pr o c es s Map Resp spon onse( se(s) s) Ap Appr prov ove ed Corr orre ectiv ctive e Act Action ion Impl mple eme ment nta ati tion on be begi gins ns Resp spon ondent( dent(s) s) revi revie ew sim s imil ila ar syst sy ste ems for fo r Pre Preve vent ntiv ive e Act Actio ion n Opportunities Eff ffe ect ctiv ive eness re r evi vie ew da d ate set set Tonya White-Salters
CA PA Pr o c es s Map Resp spon onde dent nt((s) si sign gn--of offf whe wh en imple imp leme menta ntatio tion n is comp comple lete te
Eff ffe ect ctiv ive eness is i s re r evi vie ewed and si signedgned-of off f CA R Cl o s ed Tonya White-Salters
Gov ove ern rnin ing g Au Auth thor orit ity, y, FD FDA CFR Parr t 211- Fin Pa inis ishe hed d Pha harm rma ace ceut utic ica als •Subpa ubpart rt J – Records and Re Reports •211.192 “Any unexplained discrepancy shall be thoroughly investigated. The investigation shall extend to other batches …that may have been associated with the specific failure or discrepancy. A written record of the investigation shall be made and shall include conclusions and followup.” Tonya White-Salters
Gov ove ern rnin ing g Au Auth thor orit ity, y, IC ICH Q7A – Ac A c t i v e Phar Ph arm m ac aceu eutt i c al In Ing g r ed edii en entt s 6.5 - Ba Batch tch Produc roduction tion Records 6.53 - “Written procedures should be established for investigating critical deviations or batch failures of intermediate or API to meet specifications.. Investigations should specifications extend to other batches.”
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Gov ove ern rnin ing g Au Auth thor orit ity, y, FD FDA CFR Parr t 82 Pa 820 0 - Qua uali lity ty Sys yste tem m Regu gula lati tion on Subp ubpa art J - Corr orre ecti ctive ve and Pre reve venti ntive ve Ac A ction shall ll esta stabli blish sh (a) Manufacturer sha procedures for implementing corr co rre ect ctiv ive e and pr pre eve vent ntiv ive e act ctio ion n. The procedures sha shall ll incl i nclude ude requirements for:
Tonya White-Salters
Gov ove ern rnin ing g Au Auth thor orit ity, y, FD FDA CFR Parr t 82 Pa 820 0 - Qua uali lity ty Sys yste tem m Regu gula lati tion on Subpa ubpart rt J – CAP APA A cont. (1) “ An A n al aly y zi zin n g p r o c es ess s es es,, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product” …“identify …“ identify existing and potential causes of nonconforming product, or other quality problems”…”statistical methodology shall be employed to detect re recurr curring ing qua quality lity problems problems”” Tonya White-Salters
Gov ove ern rnin ing g Au Auth thor orit ity, y, FD FDA CFR Parr t 82 Pa 820 0 - Qua uali lity ty Sys yste tem m Regu gulatio lation n Subp ubpa art J - Corr orre ecti ctive ve and Pre reve venti ntive ve Ac A ction (2) “ Investigating the cause of nonconformities relating to product, processes, and the quality system;”
Tonya White-Salters
Gov ove ern rnin ing g Au Auth thor orit ity, y, FD FDA CFR Parr t 82 Pa 820 0 - Qua uali lity ty Sys yste tem m Regu gula lati tion on (3)
“Ide dent ntif ify y action( actio n(s) s) needed t o c o r r ec t and pr pre eve vent nt re recu curr rre enc nce e of nonconforming product and other quali qua lity ty proble pro blems ms;” ;”
(4) Verifying or validating the corrective and preve p revent ntiv ive e act ctio ion n to ensure actions are effective effective;” ;”
Tonya White-Salters
Gov ove ern rnin ing g Au Auth thor orit ity, y, FD FDA CFR Parr t 82 Pa 820 0 - Qua uali lity ty Sys yste tem m Regu gula lati tion on Subp ubpa art J - Corr orre ecti ctive ve and Pre reve venti ntive ve Ac A ction (5) “Implement and record changes in methods and procedures needed t o corr co rre ect and pr pre eve vent nt identified quality problems;; problems
Tonya White-Salters
Gov ove ern rnin ing g Au Auth thor orit ity, y, FD FDA CFR Parr t 82 Pa 820 0 - Qua uali lity ty Sys yste tem m Regu gula lati tion on Subp ubpa art J - Corr orre ecti ctive ve and Pre reve venti ntive ve Ac A ction (7) Submitting relevant information on corrective and preventive actions, for m anage nagem m ent revi revie ew .
Tonya White-Salters
Fi v e Ste tep p Appr Ap proa oac ch
Implement Identify
Verify Review
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Analyze
Where Com ompani panie es Have Ha ve ffic ff icul ult y omp p ani nie Hav v e Diif iffi ficu cul ltty
Analyze Verify Review Implement Identify Tonya White-Salters
Why? Inc ncor orre rect ct Roo oott Caus use e Ide Ident ntif ifie ied! d!
Analyze: Not done Verify: Problem recurrence
Review: PA does not work Implement: CA wrong Identify: Problem but not root cause Tonya White-Salters
CAP APA A Su bsys bs yst t ems ubsy ub syst ste MRB
OOS
COMPLAINTS MANAGEMENT REVIEW
VALIDATION
CAPA
TRENDING AUDITS
TRAINING CHANGE CONTROL
RECALL
APR
DEVIATIONS
Tonya White-Salters
CAP APA A Su bsys bs yst t ems ubsy ub syst ste MRB
OOS
COMPLAINTS
VALIDATION
MANAGEMENT REVIEW
TRENDING AUDITS
TRAINING CHANGE CONTROL
RECALL
APR
DEVIATIONS
Tonya White-Salters
Example Citations
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Exa xamp mple le Cit Cita ati tion ons s - CDER Fail ilur ure e to im impl ple eme ment nt co correcti rrective ve//pr pre eve vent ntiv ive e actio ction n or conduc c onductt a thoro thorough ugh inve i nvestig stiga ation – 21 – 21 CFR 211.192 – 21 – 21 CFR 820.100 Examples Repea peated ted test failur fail ure es not n ot in investi vestigate gated d Ina nade dequ qua ate inve inv est stig iga ati tion on of faile failed d parti pa rticul cula ate inspection Tonya White-Salters
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Exxampl amp mpll e Ci tati tation on – CDER –Q7A xample • “Failure to document corrective action regarding instrument calibration check which did not meet specification”
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Ex amp mpll e Cit ita at io ion n - CBER • Failure to establish and maintain adequate procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a) and (b). For-example: • (a) The procedure titled corrective Action Handling [redacted] was not approved and implemented to address corrective and preventive action and no established procedure was found to have been in place. Tonya White-Salters
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Exampl xample e Ci tati tation on - CDRH xamp le “Failure to adequately establish and maintain procedures for implementing corrective and preventive actions as required by 21 CFR 820.100(a)(1)” Example : a. “Corrective Action Request # & # were not closed out by the QC Supervisor as required by (SOP) Corrective and Preventive Action, Rev 1; and Tonya White-Salters
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Exampl xample e Ci tati tation on - CDRH xamp le “Failure to adequately establish and maintain procedures for implementing corrective and preventive actions as required by 21 CFR 820.100(a)(1)” Example :(b) (SOP) Corrective and Preventive Action, identifies repair reports as a source for identification of potential CAPA activities; however, repair reports are not being trended or reviewed for CAPA Tonya White-Salters
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RECAP
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Recap L A CK OF ROO ROOT T CA CA US USE E ANAL ANA L YS YSIS IS
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CAP APA A Su bsys bs yst t ems ubsy ub syst ste MRB
OOS
COMPLAINTS MANAGEMENT REVIEW
VALIDATION
CAPA
AUDITS
TRAINING CHANGE CONTROL
TRENDING
RECALL
APR
DEVIATIONS
Tonya White-Salters
Questions?
Tonya White-Salters
