SOP Title: Corrective And Preventive Action
- Objective:
To lay down the systematic procedure for Effective Corrective and Preventive Actions (CAPA) for all type of discrepancies of GMP compliances or Quality System in the premise.
- Scope:
This procedure is applicable to non-conformances in manufacturing, storage, handling and testing activities and in the implementation of the Quality Management System.
- Responsibility:
All Departments Heads: Shall be responsible for identifying, notifying and investigating the cause of non-conformance in their departments, timely identifying and taking corrective and preventive actions.
QA Head: Shall be responsible for ensuring the corrective and preventive measures taken and maintaining their records and shall be responsible for responding to customer complaints.
- Accountability:
QA and All Departments Heads
- Procedure:
- Definitions:
Correction: Repair, rework or adjustment and relates to the disposition of an existing discrepancy.
Corrective Action: Action taken to eliminate causes of an existing non-conformance, defect or other undesirable situations to prevent recurrence.
Preventive Action: Action taken to eliminate the cause of the potential non-conformance, defect or other undesirable situations in order to prevent occurrence.
Concerned Department: Department in which discrepancy/non conformance have been detected and the responsibility of identifying root cause, suggesting and implementation of CAPA lies with, as per the scope of this SOP.
- Procedure:
| 5.2.1 | CAPA (Corrective and Preventive Action) | |
| 5.2.1.1 | Corrective And Preventive Action shall be required if the investigation of the reason for discrepancy reveals a need for identification of root cause and prevent its recurrence. Additionally where, situations may exist for potential non-conformance, preventive action may become necessary to prevent occurrence. | |
| 5.2.1.2 | The CAPA shall be initiated on the basis of a review of the information collected / received from one of these documents such as:
· Review of BMR, BPR and QC records. · Internal audit reports. · Market complaints. · Returned goods. · Incident reports. · Data and risk analysis related to operations and quality system. · Trending / trend evaluation. · Annual product review. · Non-conformance record and report. |
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| 5.2.1.3 | The CAPA shall be reviewed by the following personnel:
· Head QA Department. · Head QC Department. · Head Production Department. · Head Warehouse Department. |
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| 5.2.1.4 | The responsible committee shall review and investigate the root cause of the problem. If trials or experiments are required, they shall be carried out to aid the investigation. | |
| 5.2.2. | Corrective Action | |
| 5.2.2.1 | The need for any action shall be evaluated relevant to the possible consequences on Product Quality, implementation of Quality Management System, GMP compliances and Regulatory Compliances. | |
| 5.2.2.2 | Possible actions are determined, written, sent for review to the all responsible concerns and a selected action shall be taken within a defined time-frame.
Note: Corrective action is concerned with finding out why any non-conformity occurred and ensuring that the problem does not recur. It focuses on eliminating the root causes. |
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| 5.2.3 | Preventive Action | |
| 5.2.3.1 | Preventive action may be taken from a continuous evaluation or analysis of:
· Customer complaints. · Inspection and test reports. · Process monitoring data. · Audit observations. · Non-conformance records and reports. · Service reports. · Changes in regulatory requirements. · Risk analyses associated with operational and quality system processes. · Annual Product Quality Review. |
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| 5.2.3.2 | Preventive action may also sometimes be consequential to Corrective Action.
Note: Preventive action is concerned with predicting the likely occurrence of non-conformity and taking action to prevent it. |
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| 5.2.4 | CAPA report shall be prepared in a specified format with all the available information. | |
| 5.2.5 | Based on the review of the data and results of experiments (if any), the GMP Committee shall select the most appropriate corrective action to eliminate the cause of the existing non-conformance and to prevent recurrence. | |
| 5.2.6 | The GMP Committee shall authorize and initiate corrective and/or preventive actions within a defined timeframe. | |
| 5.2.7 | The effectiveness of the corrective/preventive action shall be reviewed and if it is satisfactory then the corrected procedure shall be continued as regular practice. If it is not satisfactory, GMP committee shall be informed for further necessary action. | |
| 5.2.8 | CAPA shall be closed out within 30 days of non-conformance. | |
| 5.2.9 | CAPA shall be alphanumerically numbered, the first four alphabets “CAPA” (stands for Corrective and Preventive action) followed by a slash, and last two digits of the current year followed by a slash and a three digit serial number starting from 001.
e.g. the first CAPA of year 2024 shall be numbered as CAPA/24/001. The CAPA shall be logged in the ‘CAPA Log’ form. |
- Abbreviation:
| Abbreviation | Expansion |
| GMP | Good Manufacturing Practice |
| CAPA | Corrective And Preventive Action |
| SOP | Standard Operating Procedure |
*Note – Ready to use SOP available in “DOWNLOAD” Section.