10/3/2017 SOP for Corrective Action and Preventive Action (CAPA) : Pharmaceutical Guidelines

SOP for Corrective Action and Preventive Action (CAPA)

Standard operation procedure for implementation of corrective and preventive action in different pharmaceutical departments.

1.0 OBJECTIVE:
To lay down the procedure for to be followed for administration of Corrective and Preventive actions (CAPA) including tracking and reporting of the
status of CAPA.
2.0 SCOPE:
This SOP shall be applicable for track and follow up open CAPA as well as verification of completed CAPA.
Corrective action:
Action taken to rectify, fix or correct a specific deviation, defect or undesirable situation.
Preventive action:
Action 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.
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

3.0 RESPONSIBILITY:
All Department Heads

4.0 ACCOUNTABILITY:
Head Quality Assurance
5.0 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 The "CAPA" form shall be treated as a tracking form of Corrective and Preventive actions from source document.
5.3 Initiation of CAPA:
5.3.1 Department Head shall decide the need for CAPA during initiation of any source document mentioned in Scope.
5.3.2 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 issue of form. Record of CAPA form issued shall be maintained by QA.
5.3.3 Department Head shall fill the CAPA form as under.
5.3.3.1 Write the name of the department
5.3.3.2 Date CAPA initiated
5.3.3.3 Proposed completion date
5.3.4 Carry out root cause analysis and write description based on the source document.
5.3.5 Write in brief the CAPA description from the source document and corrective and preventive action details.
5.3.6 The Department Head shall write their name with signature and date.
5.3.7 The department head shall send the CAPA form to QA.
5.3.8 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.
5.3.9 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

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10/3/2017 SOP for Corrective Action and Preventive Action (CAPA) : Pharmaceutical Guidelines

CAPA/XXX/YYY/Z
Where,
XXX: department code.
YYY: serial number, commencing at 001 for each department in calendar year.
Z: Last two digits of a calendar year.
e.g. CAPA/PRD/007/15 represents the 7th CAPA from production department in calendar year 2015

DEPARTMENT CODES

QAD - Quality Assurance Dept.

QCD - Quality Control Dept.
PRD - Production Dept.
WHD - Ware House Dept.
ENG - Engineering Dept.

HRD - Human Resource Dept.

PKD - Packaging development Dept.
EHS - Environment Health & Safety Dept.

5.4 CAPA Closure and Verification:

5.4.1 On completion of actions, the department head shall certify that the proposed CAPA is completed and implemented along with associated
actions.
5.4.2 QA shall verify the implementation and completion of CAPA with review of supporting documents and certify the same.
5.5 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.
5.6 All Deviations, Discrepancy reports giving rise to CAPA shall be addressed through CAPA form.
5.7 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.
5.8 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.
5.9 Department Head shall compile the CAPA information and submit the summary to the Management during GMP Committee meeting /
Management Review Meeting.
5.10 Management shall review / verify the same quarterly in Management Review Meeting.
5.11 Information and documents related to CAPA drawn form 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.

6.0 ABBREVIATIONS:
6.1 SOP: Standard Operating Procedure
6.2 CAPA: Corrective Action and Preventive Action
6.3 GMP: Good Manufacturing Practices
6.4 OOS: Out of Specification
6.5 GM: General Manager

ANNEXURE-1
Request form for CAPA

Originating Department Date

Name
Request No.
Present Process / Problem :

Proposed Action (If any ):

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10/3/2017 SOP for Corrective Action and Preventive Action (CAPA) : Pharmaceutical Guidelines

Acceptance Criteria of proposed action :

Approval by Head of Originating Department :

Signature/Date

ANNEXURE-2
FORMAT FOR CORRECTIVE AND PREVENTIVE ACTION
Department Name :- Report No.
Ref. request No.(if any):-
Description :

Corrective action:- Target date of Completion

completion Date

Preventive Action :-

Acceptance Criteria :-

Approval:-

Head Originating department Head Quality Assurance

(Sign./Date) (Sign./Date)
Implementation and Follow up verified by

Originating department Quality Assurance

(Sign./Date) (Sign./Date)

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10/3/2017 SOP for Corrective Action and Preventive Action (CAPA) : Pharmaceutical Guidelines

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Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read
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