Corrective Action and Preventive Action (CAPA)

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.

Initiation of CAPA:

1. The initiation of CAPA requires submission of the source document by concerned Department Head to QA.

2. Department Head shall decide the need for CAPA with Head QA.

3. 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 issuing of form.

4. Department Head shall fill the CAPA form as under.

A) Date CAPA initiated

B) Proposed completion date

C) Select the department initiating the CAPA by making a √ mark in the appropriate box.

D) Select the relevant system affected by making a √ mark in the appropriate box. If none of the systems printed are affected select, Not applicable. If any other system other than those mentioned is affected, write the system in blank spaces provided.

E) Write in brief the CAPA description from the source document and corrective and preventive action details.

F) The Department Head shall write their name with signature and date.

5. The department head shall send the CAPA form to QA.

6. 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.

7. 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/XXX/YYY/ZZ

Where,

XXX: department code.

YYY: serial number, commencing at 001 for each department in the calendar year.

ZZ: Last digit of a calendar year.

e.g. CAPA/PRD/007/13 represents the 7th CAPA from production department in the calendar year 2013.

DEPARTMENT CODE

Prefix    Department

QAD     Quality Assurance Dept.

QCD     Quality Control Dept.

PRD      Production Dept.

WHD    Ware House Dept.

ENG     Engineering Dept.

HRD     Human Resource Dept.

RAD     Regulatory Affairs Dept.

Related: Importance of APR in Quality Improvements

CAPA Closure and Verification

1. On completion of actions, the department head shall certify that the proposed CAPA is completed and implemented along with associated actions.

2. QA shall verify the implementation and completion of CAPA with the review of supporting documents and certify the same.

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.

4. All Change Controls, Deviations, Discrepancy, Incident Reports giving rise to CAPA shall be addressed through CAPA form.

5. All facility up-gradations / Capital purchase requirements / major changes in the quality system and compliance to regulatory commitments giving rise to CAPA shall be addressed through CAPA form.

6. The record of each CAPA shall be maintained.

7. Copy of the completed CAPA shall be provided to the concerned Dept. Head by QA Department Head shall compile the CAPA information and submit the summary to the Management during GMP Committee meeting / Management Review Meeting.

8. Management shall review/verify the same quarterly in Management Review Meeting.

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 Vice President QA.

Source documents of CAPA are identified as:

• GMP Investigations

• Deviations

• Change control

• 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

Also see: Procedure for Change Control in Pharmaceuticals