SOP for Corrective Action and Preventive Action in Pharmaceutical Industries | Corrective Action and Preventive Action Procedure |
- CAPA SOP covers below points :
- Corrective action and preventive action definition
- Some example of CAPA
- Purpose of CAPA
- Initiation of CAPA
- Root Cause Investigation of CAPA
- Verification of CAPA
- Final Conclusion and Closure of CAPA
- CAPA Extension
- CAPA format
- CAPA Log Book
1.0 OBJECTIVE :
- This SOP provides a system for correcting non conformity which can affect the quality of the product and preventing it from recurring.
2.0 SCOPE :
- This SOP is applicable for corrective action and preventive action (CAPA) purpose for any non conformity.
3.0 RESPONSIBILITY :
- Head of Quality Assurance, Quality Control, Production, Warehouse, Engineering and H.R. is responsible for compliance of this SOP.
- Quality Assurance Head
5.0 PROCEDURE :
5.1 The trigger for Corrective Action and Preventive Action is non conformity. Non conformity is fulfillment of specified requirement. CAPA is decision and action oriented. It is applicable in case of any nonconformity (Rejection) and Accidents.
Corrective actions are the act, process or the action taken to correct the non conformity so that the non conformity will conform to the acceptable standards. It may include correction of incorrect printing on packing material, reprocess and rework of rejected goods.
Preventive action is the action taken to avoid the occurrence of such non conformity in future or to prevent the repeated non conformity.
- Some example of CAPA
- Replacing the label on any device that had the wrong label applied.
- Revising process parameters in response to complaints.
- Revisiting equipment maintenance procedures to reduce drift in process specification.
- Purpose of CAPA
- Collect and analyze information based on appropriate statistical methodology (Pareto charts, Control Charts, Standard Deviation, etc.) as necessary to detect recurring quality issues.
- Identify and investigate existing and potential product and quality problems.
- Take appropriate, effective and comprehensive corrective action and/or preventive action.
5.2 If any non conformity is observed, then stop the further processing and quarantine the non conformed product and keep it under hold dully labeled. Carry out the detailed investigation and know the root cause. If the non conformity is major and will affect the product quality, safety or efficacy and any violation to the regulation then plan the corrective actions as applicable so that product will comply with specification. If the non conformity is not as above then deviation can be filed as per procedure to approve the product. Based on the root cause the preventive action shall be taken so that recurrence of such events will be avoided. Any deviation filed shall be closed immediately. If required revise the SOP and give the training to the operating and concerned personnel’s.
The time limit is 90 days for closing of non conformity. After completion of time period Quality Assurance should verify the effectiveness of corrective and preventive action and closing of non conformance.
5.3 After receiving the non conformity or the non conformity was detected, Quality Assurance Head has to justify the non conformity to do a corrective and preventive action.
5.4 The source of non conformity are as follows :
- Manufacturing Deviation
- Internal Audit ( Self Inspection or Quality Assurance Round) and / or Regulatory Audit
- Product Complaint and / or Product Recall
- Annual Product Quality Review etc.
- Laboratory Investigations
- External / Customer Audits
- Regulatory Inspection Reports
- Changes in regulatory / Pharmacopeia requirements
- Product failures
- Returned Goods
- Incidents Reports
- Issue the format as per verbal request from any departmental head or his/her designee, chemist and above of Quality Assurance department will issue blank working copy of Corrective Action and Preventive Action (CAPA) form (Refer Annexure No. 01) and will also get acknowledgement from requesting department on format issue register.
- The CAPA request department shall enter the detail in Corrective Action and Preventive Action (CAPA) form.
- Officer / Executive of Quality Assurance department shall log the CAPA in CAPA Log book (Refer Annexure No. 04) and allocate the CAPA number as follows :
- CAP : Corrective Action and Preventive Action
- 00 : Last two digits of Calendar Year in which CAPA reported
- 000 : Serial number
- Eg. CAP/22/001
- Where, 001: Represents the first Corrective Action and Preventive Action number allotted in the year 2022.
5.6 Root Cause Investigation
- Quality Assurance Head or his/her Designee along with the concerned department Head first carryout the investigation as per the Failure Investigation SOP to determine the root cause of the non conformity and note down the same in CAPA form in PART1 (Annexure No. 1). The Root Cause Investigation is prepared by concerned department Head and checked by Quality Assurance Head.
- Quality Assurance Head along with the concerned department head then suggest the Corrective Action and Preventive Action to be taken in PART 2 (Annexure No. 01) and assign the job to responsible person of concerned department with the Name and Designation is written in Responsible Staff column and the date for completion is written in Target date to be completed column. CAPA should be completed within 90 days of its initiation.
- After the Corrective and Preventive action taken, the staff who completed the action write the necessary details in the Corrective Action and Preventive action taken columns with the Name and Designation in action taken by column and the completion date in respective column in PART 2 (Annexure No. 01). The above information is checked by concerned department Head and if found OK, submit the form to Quality Assurance Head for evaluation and approval with Sign and Date.
- Quality Assurance Head shall make sure that all the Corrective Action and Preventive Action are completely carried out as per suggestions.
5.7 Verification of CAPA
- On completion of actions, the department head shall certify that the proposed CAPA is completed and implemented along the associated actions.
- The concerned department head fills the necessary details in the Verification of the Corrective Action Taken and Verification of the Preventive Action Taken columns and verified by Quality Assurance Head in PART 3 (Annexure No. 01).
- Quality Assurance Head shall verify the implementation and completion of CAPA with review of supporting documents and certify the same.
- Any change proposed as a result of CAPA shall be through the SOP on change control and same shall be mentioned in the CAPA form.
5.8 Final Conclusion and Closure
- The Final Conclusion is filled by Quality Assurance Head after checking the effectiveness of the Preventive Action in PART 4 (Annexure No. 01).
- Quality Assurance department routinely check the effectiveness of the action taken by monitoring the non conformity to ensure that the same non conformity will not occur again and then give the feedback regarding the same to Quality Assurance Head.
- After receiving the feedback, Quality Assurance Head will decide whether the preventive Action is Effective or not and then only close the CAPA.
- If the same non conformity recurs, the preventive action needs to be reviewed again and strict actions to be taken by Quality Assurance department to stop the recurrence of the same non conformity.
- Quality Assurance shall notify the CAPA closure to the CAPA owner and other relevant department as applicable.
- The record of each CAPA shall be maintained.
5.9 CAPA Extension
- In case of exceeding the committed CAPA closure date, the CAPA owner shall initiate a request for extending the closure date.
- Initiate the CAPA extension form and write the reason for delay.
- Propose new date of implementation and justification of new date.
- Quality Assurance Head shall review the extension form and approve the extension if applicable. Where appropriate, escalation of the delay shall be done by Quality Assurance to various management levels for expeditious resolutions, Quality Assurance Officer or his/her Designee shall enter the proposed new target date of CAPA implementation and update his/her name in ‘CAPA extension updated by’ column (Annexure No. 03).
|Standard Operating Procedure
|Out of Trend
|Standard Test Procedure
|Corrective and Preventive action
|Format for Corrective Action and Preventive Action Form
|Format for CAPA Extension
|Format for Corrective Action And Preventive Action Log Book
8.0 SOP REFERENCES
- GMP Guidelines
END OF THE SOP
What is CAPA – Corrective and preventative action ? click below link for more information on CAPA.
Annex. No. 01 Format for Corrective Action and Preventive Action Form
Annex. No. 02 Format for CAPA Extension
Annex. No. 03 Format for Corrective Action And Preventive Action Log Book