1.0 PURPOSE:
This procedure ensures that discrepancies in GMP compliance/quality systems are investigated, corrective actions are taken to eliminate the root causes of non-conformances, and preventive actions are taken to eliminate the causes of potential non-conformances.
2.0 SCOPE:
This procedure applies to the implementation of corrective actions and preventive actions resulting from the investigation of following non-conformances in manufacturing and testing activities.
A) Internal Data/Records
1. Deviation Reports
2. Self-Inspection/Internal Audit Reports
3. In-process / Inspection Results…etc
4. Risk Assessment and Findings
5. Change Control Reports
6. Annual / Quarterly trends of QMS Documents
7. Product Quality Review
8.OOS/OOT
9. Laboratory Deviations
10. Training…etc
B) External Data
1. Market
2. Service Reports
3. Product Recall
3.0 RESPONSIBILITIES:
All Departments Heads
4.0 DEFINITIONS:
4.1 Corrective Action:
Action is taken to eliminate the causes of a detected non-conformance, defect or other undesirable situations to prevent recurrence.
4.2 Preventive Action:
Action is taken to eliminate the cause of the potential non-conformance, defect, or other undesirable situations to prevent occurrence.
4.3 CAPA (Corrective and Preventive Action):
A systematic approach includes actions needed to correct (correct), prevent recurrence (corrective action), and eliminate the cause of potential (preventive action), non-conforming products, and other quality problems.
4.4 Discrepancy: Data or results outside of the expected range; an unfulfilled requirement, may be called non-conformity, defect, deviation, out-of-specification, laboratory deviation, or out-of-trend.
5.0 PROCEDURE:
5.1 CAPA shall be initiated based on the investigation of the discrepancies reported related to the process, procedure, and systems, “Scope” of this procedure to prevent the occurrence and reoccurrence of the existing discrepancies/deficiencies.
5.2 CAPA shall be proposed after conducting a comprehensive root-cause analysis in relevant procedures for handling discrepancies. A multi-disciplinary team comprising persons involved in the process during the occurrence of the discrepancy (from the Originating department) and/or personnel from other departments affected by the discrepancy and Site QA personnel shall perform the Root Cause Analysis.
5.3 CAPA shall be initiated if the review of the trend of internal or external data of the systems/procedures, indicates any repeat deficiency or an adverse trend potentially impacting the quality system or quality of the product.
5.4 For ease of handling CAPA system is divided into three phases.
Phase I-Initiation, Assessment, and Approval of CAPA
Phase II-Implementation of CAPA, Review of Implemented CAPA, and Closure of CAPA
Phase III-CAPA Effectiveness Monitoring and Closure
5.4.1 Phase I — Includes initiation of CAPA along with the action plan for the activities to be completed, CAPA effectiveness monitoring plan, review and approval of CAPA.
5.4.2 Phase II — Includes implementation of CAPA within the target timeline, training to target group, Controlled review of implementation, and closure of CAPA.
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