Sop on Corrective and Preventive Action
Objective : To lay down a procedure for the Corrective and Preventive Action so as to eliminate the causes of potential non-conformities and /or encountered non-conformities in order to prevent their occurrence and/or recurrence.
Scope : This Standard Operating Procedure shall apply to all corrective and preventive action taken in the formulation plant of (Pharmaceutical Company Name).
Responsibility
- The concerned Department Head and QA Head shall be responsible for identifying the need for CAPA.
- Concerned Department Head and QA Head shall be responsible for completion of the proposed CAPA.
- QA Head shall be responsible for ensuring that all CAPA identified during all investigative processes are included, maintained and updated in the record of corrective and preventive action.
Accountability: QA Head/ designee shall be accountable for implementing this SOP.
Abbreviations and Definitions
CAPA: Corrective Action and Preventive Action
Non-conformities: Non-conformities in products, manufacturing process, SOP, utility, equipment, building, and facilities with respect to predetermined acceptance criteria, specifications, or cGMP elements.
Corrective Action: The action taken to eliminate the causes of an existing non-conformity, defects or other undesirable situation in order to prevent a recurrence, to a degree appropriate to the magnitude of problems and adequate with the risks encountered.
Preventive Action:
The action taken to eliminate the causes of a potential non-conformity, defects, or other undesirable situation in order to prevent the occurrence, to a degree appropriate to the magnitude of problems and adequate with the risks encountered.
Procedure
Initiation of CAPA:
The Concerned Department shall identify and clearly define the potential non-conformities and/or review encountered non-conformities arising out of procedures like Handling of Deviations in Facility, Standard Operating Procedures, Batch Manufacturing Records and Specifications; Internal Audits; Change Control; Handling of Product Complaints; Product Recall; Handling of Non-conforming In-process and Finished products; non-conforming delivery from vendors, etc.
The Concerned Department along with any other relevant department, if applicable,shall determine the causes of non-conformities.
The Concerned Department shall submit the corresponding document or source document (e.g NCR form, Complaint Information Form, Deviation Report, Internal Audit Report, Product Recall – Investigation and Disposition, Change Control etc.) to QA Head.
QA Head along with Concerned Department Head shall decide the need for the CAPA. If need identified than QA personnel shall issue the CAPA Form (Annexure –I) and allot the CAPA No.,as CAPA/XXX/YY, where:
- CAPA – Corrective and preventive action
- “/” – ‘Slash’
- XXX – Serial number, commencing from 001 in calendar year
- YY – Last digit of the calendar year.
- e.g.: CAPA/002/24 represents 2nd CAPA in calendar year 2024.
Make relevant entries in the logbook titled “Record of Corrective and Preventive Action (as per Annexure –II).
After assigning the CAPA No. QA Personnel shall write the details of the corresponding source document (name & number).
The CAPA Form then shall be forwarded to the Concerned Department.
The Concerned Department shall fill in the form with the description of identified nonconformity and necessary corrective action is taken and intimate to QA for verification.
QA personnel shall verify the non-conformity, and corrective action with their impact and put their signature with the date in the relevant column.
After that Concerned Department Head shall carry out an investigation to identify the cause of the non-conformity along with verification from the QA Department.
During the investigation, if required concerned department shall take the comments from any other department.
The investigations and comments of another department shall be verified by QA along with the sign & date.
After the completion of the investigation, a proposed preventive action shall be identified with their target completion date.
In case the proposed preventive action is not completed due to genuine reasons than the target completion date shall be revised by taking permission from the QA Head.
A proper justification or reason for the revised target date shall be given by Concerned Department which shall be verified by the QA department.
CAPA Closure and Verification:
On the target completion date, the Concerned Department Head shall verify that the proposed CAPA is completed within the specified time period and implemented along with associated actions.
QA Head shall evaluate the implementation of proposed action within the target completion date and completion of CAPA form by reviewing of supporting documents
If any change proposed as a result of CAPA shall be done through SOP on Change Control and reference of the same shall be mentioned in the CAPA format.
All change controls, deviations, discrepancies, NCR, incident reports giving rise to CAPA shall be addressed through CAPA form.
The record of each CAPA shall be maintained.
After doing all above given activities CAPA shall be closed by Head QA.
Forms and Records
- CAPA Form : Annexure -I
- Record of Corrective and Preventive Action: Annexure -II
Distribution
- Master Copy – Quality Assurance
- Controlled Copies – Quality Control, Quality Assurance, Stores, Production, Engineering.
