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Cqa-005-00 Capa

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93 views14 pages

Cqa-005-00 Capa

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bubbles82
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ARS Pharmalabs Ltd., India STANDARD OPERATING PROCEDURE. | TITLE: CORRECTIVE AND PREVENTIVE ACTIONS: ‘SOP NO.: “cawvo0s-00 DEPARTMENT: Corporate Quality Assurance ‘SUPERSEDES SOP Training EFFECTIVE NO.: NA PAGE NO.: Copy 1 of 11 DATEI 1.0 APPROVAL Prepared By ~ User Department Harsha) Samant. 03-08-2011 Name ‘Signature / Date Reviewed By ~ Head of The User Department / Designee Plu vax Obprom= ‘Signature /Date Approved By ~ Head Quality Assurance / Designee Name Signature / Date | PRR Rohr ude oe CQA001/F01-00 AR Pharmalabs Ltd., India STANDARD OPERATING PROCEDURE. TITLE: CORRECTIVE AND PREVENTIVE ACTIONS, 'SOPNO: | caAr0so0 |DEPARTMENT: | Corporate Quality Assurance ‘SUPERSEDES SOP era EoT EFFECTIVE eer paceno.: | iuadiniing DATE: Me 2oftt Copy | DATED: NA OBJECTIVE To describe a comprehensive, systematic approach for managing Corrective Actions and Preventive Actions for the resolution of non conforming events identified for systems, procedures and standards. 3.0 SCOPE This Standard Operating Procedure is applicable to corrective actions and preventive actions planned or to be completed for the resolution of non conforming events identified for systems, procedures and standards such as Incidences, Deviations, Aberrant results, Out of trend (OOT) and Out of specification (OOS) results, Product complaints, Validations, Annual Product Reviews, Laboratory operations, Interal audits etc. 4.0 RESPONSIBILITY 4.1. Department employees: For identification, reporting and providing information during investigation and assessment of Effectiveness of CAPA. 4.2 Department Heads or Designee: For identification, evaluation, documentation and implementation and assessment of effectiveness of the corrective and preventive actions and ensure compliance to the SOP. 4.3. Head-Quality Assurance or designee is responsible for the tracking of the CAPA, implementation and to ensure the compliance to this SOP. 5.0 DEFINITION(s) 5.1 Deviation A deviation is a planned activity performed differently and/or modified than that specified in an approved document that has the potential to affect the safety, identity, strength, quality or purity of a raw or packaging material, in-process. material or drug product , covering a specified period of time or a specified number of batches. SanoourD1-00 ‘Approved By orate): ES AR Pharmalabs Ltd., India STANDARD OPERATING PROCEDURE. TiTLi SORRECTIVE AND PREVENTIVE ACTIONS SOP NO.: CQa00s-00 | DEPARTMENT: Corporate Quality Assurance | EFFECTIVE DATE: ‘SUPERSEDES SOP —— NO. NA PAGE NO.: i tlh 2 3of 11 opy DATED: NA 52 53 54 55 56 6.0 PROCEDURE 64 ©QA001/F01-00, Incident ‘An incident can be defined as any untoward event, occurrence or unplanned deviations at any stage of manufacturing, packaging, testing, holding and distribution of drug product and/or components which may have potential to impact on a drug product safety, identity, strength, quality or purity due to system or process fallure, equipment breakdown, or manual error. Corrective Action ‘Action(s) taken to resolve or correct existing non conformity, investigate to identify the root cause, address the identified root cause(s) and/or eliminate the cause(s) of existing non-conformance, problem, etc. Preventive Action Action(s) taken to eliminate root cause of potential non-conformance, defect or undesirable situation to prevent future non conformance. Root Cause(s) The proven reason for the cause of the existing non conformity based upon the results of the investigation which when addressed will prevent its recurrence ete. Aberrant Results Any laboratory test result (including individual data points when replicate sample preparations are analyzed) that is demonstrated to be inconsistent with historical data. The requirement of the corrective and preventive actions is involved in following events (but not limited to} 6.1.1. Deviations 6.1.2 Incidents A Pharmalabs Ltd., India STANDARD OPERATING PROCEDURE TITLE: CORRECTIVE AND PREVENTIVE ACTIONS. soPNO.: | cQAio0s-00 | DEPARTMENT: Corporate Quality Assurance ‘SUPERSEDES SOP EFFECTIVE : PAGE NO.: DATE: oe arty DATED: NA 6.4.3 Outof trend (OOT) results 6.1.4 Out of specification (00S) 6.1.5 Product complaints 6.1.6 Process validation 6.1.7 Product recalls 6.1.8 External and Internal Audits 6.1.9 Equipment qualification 6.1.10 Cleaning validation 6.1.11 Change Control 6.1.12 Annual Product Review | 6.1.13 Validation Master Plan is because, they may affect: 6.2.2 Regulatory implications 6.2.3. Patient safety. 6.4 Corrective Actions 64.2.1 Remedial Actions: 6.2.1 Safety, purity, potency or effectiveness of the product. 6.4.2 The corrective actions can be divided into two sections: 6.2 The need for implementing Corrective and Preventive Actions for all these events | 6.3 Corrective and preventive action report should be filled as per Attachment # 2. 6.4.1 Corrective actions are taken to eliminate the cause of an existing non conformity or detected undesirable event. COA001/F 01-00 ‘Approved By (Signature) =f AR Pharmalabs Ltd., India STANDARD OPERATING PROCEDURE TITLE: CORRECTIVE AND PREVENTIVE ACTIONS. ‘SOP NO.: CQA/005-00 | DEPARTMENT: Corporate Quality Assurance ‘SUPERSEDES SOP Wg EFFECTIVE sai PAGE NO.: Deeirtns DATE: “ Sof 11 Opy DATED: NA Remedial actions are actions taken to eliminate or control a detected non conformity prior to the root cause determination. For eg, if a non conformity is that an instrument has not been calibrated, the remedial action would be to get the instrument calibrated before finding out the root cause for non conformity. | [Link] Root Cause determination: This is the investigation conducted to find the pre reason for the detected non conformity. The investigation includes review of existing data, discussions, past trends and situation at the time of, detected non conformance. 6.4.3 The proposed corrective action must satisfy the following | requirements: [Link] Resolution of a current non conformity 64.32 Ifimmediate resolution is not possible, alternative [Link] The various actions must be planned along with corresponding target dates of completion, [Link] Each proposed corrective action must have a responsible owner. 64.3.5 Area of implementation [Link] Description of events mentioned in proposed actions [Link] The proposed corrective actions must be recorded in respective formats of relevant SOP’s along with a distinctive number for each incident. 64.3.8 _In case the detected non conformity is a recurred event, the corrective actions planned for the earlier events must be evaluated by a team investigating the current non assessment must be made CQA001/F01-00 Approved By (Signature) conformance. AR Pharmalabs Ltd., India STANDARD OPERATING PROCEDURE, TITLE: CORRECTIVE AND PREVENTIVE ACTIONS, ‘SOP NO.: CQA/005-00 | DEPARTMENT: Corporate Quality Assurance ‘SUPERSEDES SOP PEEECUVE ‘1 PAGE NO.: | DATE: we 6 of 11 DATED: NA. t = ale For recurring events, possibility of ais control must be evaluated. 64,3.10 Close out for Corrective Actions 65 Preventive Actions | 6.5.1 Action(s) taken to eliminate root cause of potential nonconformance, | defect or undesirable situation to prevent future non conformance, Preventive action is different from corrective action in that corrective action is taken to prevent recurrence of existing event whereas preventive action is taken to prevent occurrence of event. It is more of a proactive measure taken to prevent occurrence of the event on the systems that are yet unaffected but may be potential victims of the existing defect. 6.5.2 Preventive actions taken can be divided into two sections: 65.21 Impact Assessment: This is a procedure by which the impact of the current non conformity is assessed on the other systems as well | as overall situation. The loopholes can be plugged in the existing scenario that can affect the now unaffected systems Examples of impact assessment and taking steps to cur their negative impact on the other system existing could be an introduction of new standard operating procedure or introduction of new system as a checkpoint to safeguard other systems. 65.22 Continual Improvement: This is the procedure that identifies and addresses the Improvements in the system or procedure along with the potential sources events. | . g. Introduction of automatic machine, trend observed in annual product review. CQA001/F01-00 Awoved By Cigna) S ARN Pharmalabs Ltd., India STANDARD OPERATING PROCEDURE TITLE: CORRECTIVE AND PREVENTIVE ACTIONS. ‘SOP NO.: cawoos.o0 | DEPARTMENT: Corporate Quality | Assurance ‘SUPERSEDES SOP ink EFFECTIVE NGRA PAGENO: | ‘eat DATE: a Toft Py DATED: NA 6.5.3 The following continual improvement cycle can be referred for improvements in the existing practices. Plan + Define the improvement + Perform the impact assessment * Create the solutions, + Prepare action plan. Act * Correct if required + Standardize the improvement. Review * Review the effectiveness of implementation. Perform + Implement the actions. CQA001/F01-00 ‘Approved By (Signature) :_ Rw AR Pharmalabs Ltd., India STANDARD OPERATING PROCEDURE TITLE: CORRECTIVE AND PREVENTIVE ACTIONS: ‘SOP NO.: CQA/005-00 | DEPARTMENT: Corporate Quality Assurance ‘SUPERSEDES SOP THamAL EFFECTIVE age PAGE NO.: [Sige THEN DATE: Bof 11 | Py DATED: NA 4 During impact assessment, the control points and risks associated with all activities within the process shall be considered. 6.5.5 The proposed preventive action must include the following: 65.5.1 Anoverall assessment of all the systems. 65.52 The various actions planned along with corresponding target dates of completion 65.6.3 Each proposed preventive action must have a responsible owner 65.5.4 Areas of implementation [Link] Description of events mentioned in proposed actions [Link] The proposed preventive actions must be recorded in respective formats of relevant SOP's along with distinctive number for each incident 65.5.7 Training to the personnel on the systems to be introduced, new documentation to be prepared. 65.5.8 Review of the actions and assessment its effectiveness over a period of time. 655.9 Follow up (if required) 6.55.10 Finalization of actions through change control procedure. [Link] __ In case the detected non conformity is a recurred event, the corrective actions planned for the earlier events must be evaluated by a team investigating the current non conformance. 655.12 For recurring events, possibilty of raising a change control must be evaluated. 6.55.13 Close out for proposed Preventive action CQA001/F01-00 Approved By (Signature) Se ARN Pharmalabs Ltd., India STANDARD OPERATING PROCEDURE TITLE: CORRECTIVE AND PREVENTIVE ACTIONS. SOP NO.: CQA/005-00 DEPARTMENT: Corporate Quality L | Assurance t - | SUPERSEDES SOP ia | EFFECTIVE ay PAGENO.: [0 raining DATE: i 9of11 Opy | DATED: NA 6.6.1 662 66.3 66.4 67 674 672 67.3 674 (CQA001/F01-00 Extension of due dates for Correcti Assessment of Effectiveness of Corrective and Preventive Actions and Preventive Action: All Proposed Corrective and Preventive actions must have a target date of completion in an approved CAPA document recorded in respective formats of relevant SOP's. ‘The CAPA dates are considered overdue if the target dates are not met. The extension for due dates must be approved by Site Quality Assurance, Following criteria must be considered for extension of due dates: 66.4.1 Appropriate justification is provided 66.4.2 Adequate impact assessment is made (such that the ‘extension of target dates does not have an impact on other systems). 66.4.3 _ Interim status report is attached with the justification Critical element for determining the effectiveness of Corrective and Preventive actions in the data or information is the confirmation that the actions proposed were performed according to the expectations, Not all corrective and preventive actions require assessment of effectiveness. The timeline and methodology to determine the effectiveness of CAPA must be identified in an approved document where CAPA has been identified and approved. (For e.g. 3 months after completion of CAPA), Tools or approaches that may be used to assess the effectiveness of CAPA include but are not limited to the following: ‘Approved By (Signature): ZS Qyyr— AR Pharmalabs Ltd., India STANDARD OPERATING PROCEDURE TITLE: CORRECTIVE AND PREVENTIVE ACTIONS (Current version) SOP NO. CQA/005-00 | DEPARTMENT: Corporate Quality Assurance SUPERSEDES SOP RRAiniRS EFFECTIVE iO PAGE NO.: fs BATE: : 40 of 11 Copy DATED: NA 6744 tograms & [Link] Charts (for productivity improvement assessment) [Link] Review of records (for documentation errors) [Link] Visual Inspections (for reported on the job errors) [Link] Interview with employees (training issues) 67.46 Mock drills 67.4.7 Unit Operations 7.0 REFERENCE(s) Reference SOP No. Title CQA/002 ‘Change Control System: CQA003 Handling of Deviations ‘CQA/007. Handling of Incidents ‘CQA/008 Investigation of OOS Result COA0I4 ‘Annual Product Review ‘CQAIOI7. Handling of Product Complaints ‘COA0IS Product Recall & Market Withdrawal 8.0 ABBREVIATION(s) ‘Abbreviation i ‘SOP ‘Standard Operating Procedure No. ‘Number CAPA Corrective action and preventive action IN Incident DV Deviation cc ‘Change Control MC Market Complaint C@A001/F01-00 Approved By (Signature) BY. — AR Pharmalabs Ltd., h STANDARD OPERATING PROCEDURE TITLE: CORRECTIVE AND PREVENTIVE ACTIONS ‘SOP NO.: CQa/00s-00 | DEPARTMENT: Corporate Quality Assurance SUPERSEDES SOP PS EFFECTIVE PAGE NO.: (PRATER ea ttoftt 9.0 FLOWCHART(s) Attachment #1 (Flow chart for Management of CAPA). 10.0 ATTACHMENT(s) Format No. ‘Attachment No.| Details/Title of Attachment (cameesicny ‘Attachment # 1 | Flow chart for Management of CAPA | CQA0O8/F01-00 ‘Altncheient #2 | Comectiveiand Fraventive Action CQA005/F02-00 eport 44.0 CHANGE HISTORY Change control No. Supersedes Effective Date = None Summary of Changes ls New SOP — Approved By (Signature): _

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