SOP for Corrective and Preventive Action

1. OBJECTIVE
To lay down the procedure for to be followed for the administration of Corrective and Preventive Actions (CAPA) including tracking and reporting of the status of CAPA

2. SCOPE
This procedure is applicable for track and follow up open CAPA as well as verification of completed CAPA

3. RESPONSIBILITY
• All Department Heads
• Quality Assurance Head

4. DEFINITIONS
• Corrective action:
The action was taken to rectify, fix or correct a specific deviation, defect or undesirable situation.
• Preventive action:
The action was taken to eliminate the cause of deviation, defect, or other undesirable situation in order to prevent the future occurrence of such or similar an event

5. PROCEDURE
5.1 Source document shall provide the proposed corrective and preventive actions. The proposed corrective and preventive actions shall be approved by QA prior to implementation. The proposed corrective and preventive actions shall be verified during CAPA evaluation in form.
5.2 Source documents of CAPA are identified as:
• GMP Investigations
• Deviations
• Laboratory (OOS) Investigations
• Internal Audit Reports
• External / Customer Audits
• Annual Product Reviews
• Regulatory Inspection Reports
• Management Action Plans
• Changes in regulatory / Pharmacopoeia requirements
• Product Failures
• Complaints
• Product recall
• Returned Goods
• Incidence Reports
• Discrepancies
5.3 The “CAPA” form shall be treated as a tracking form of Corrective and Preventive actions from the source document.
5.4 Initiation of CAPA:
5.4.1 Department Head shall decide the need for CAPA during initiation of any source document mentioned in Scope.
5.4.2 The Department Head shall get a CAPA form issued from QA. QA shall write the source document name and Source document number on the form before the issue of form. Record of CAPA form issued shall be maintained by QA.
5.4.3 Department Head shall fill the CAPA form as under.
5.4.4 Write the name of the department
5.4.5 Date CAPA initiated
5.4.6 Proposed completion date
5.4.7 Carry out root cause analysis and write the description based on the source document.
5.4.8 Write in brief the CAPA description from the source document and corrective and preventive action details.
5.4.9 The Department Head shall write their name with signature and date.
5.4.10 The department head shall send the CAPA form to QA.
5.4.11 GM QA / Designee shall allot a reference number to the CAPA form and make relevant entries in the CAPA log. Forward the CAPA form to the concerned department.
5.4.12 The CAPA shall be numbered serially in the calendar year for each department with an identification code of department. A typical CAPA form shall be numbered as
CAPA/00X/ YYYY
Where,
XXX: serial number
YYYY: digits of a calendar year.
5.5 CAPA Closure and Verification:
5.5.1 On completion of actions, the department head shall certify that the proposed CAPA is completed and implemented along with associated actions.
5.5.2 QA shall verify the implementation and completion of CAPA with review of supporting documents and certify the same.
5.5.3 Any change proposed as a result of CAPA shall be through the SOP on Change Control. Reference of the same shall be mentioned in the CAPA format.
5.5.4 All Deviations, Discrepancy reports giving rise to CAPA shall be addressed through CAPA form.
5.5.5 All facility up-gradations / Capital purchase requirements / major changes in quality system for compliance to regulatory commitments giving rise to CAPA shall be addressed through CAPA form.
5.5.6 The record of each CAPA shall be maintained.
Copy of the completed CAPA shall be provided to the concerned Dept. Head by QA. A copy of CAPA form shall be attached to the source document.
5.5.7 Department Head shall compile the CAPA information and submit the summary to the Management during GMP Committee meeting / Management Review Meeting.
5.5.8 Management shall review / verify the same quarterly in Management Review Meeting.
5.5.9 Information and documents related to CAPA drawn from internal audits, external/ Customer audits and regulatory inspections are considered confidential and can only be made available to regulatory review when approved by Director Technical and Sr. Vice President.

6. RELATED DOCUMENTS
CAPA Format – Annex-I

7. DISTRIBUTION INDEX
Original Copy will be retained by Quality Assurance Department.

8. ABBREVIATIONS
Q.A Quality Assurance Department
CAPA Corrective Action and Preventive Action
GMP Good Manufacturing Practices

9. REVISION HISTORY