PHARMA DEVILS

QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Quality Assurance SOP No.:
Title: Corrective action and Preventive Action (CAPA) Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

1.0 OBJECTIVE:
To lay down the Procedure for Corrective and Preventive Action(s) (CAPA).

2.0 SCOPE:

This SOP is applicable for all Corrective and Preventive Action(s) that are recommended and to be
documented at ………………….

3.0 RESPONSIBILITY:
QA (Officer/ Executive): Preparation, Distribution, Revision, Retrieval and Destruction of this SOP.
Issuance of CAPA form and to maintain the log.

4.0 ACCOUNTABILITY:
Head QA: Approval, ensure Training and Implementation of this SOP. Approval/Rejection of CAPA.

5.0 DEFINITIONS:
5.1 Non-Conformities: Non-conformities in products, manufacturing process, equipment, building and
facilities with respect to predetermined acceptance criteria, specification, or cGMP elements.
5.2 Corrective Actions: The action taken to eliminate the causes of an existing non-conformity, defects or
other undesirable situation in order to prevent recurrence, to a degree appropriate to the magnitude of
problems and adequate with the risks encountered.
5.3 Preventive Actions: The action taken to eliminate the causes of a potential non-conformity, defects or
other undesirable situation in order to prevent occurrence, to a degree appropriate to the magnitude of
problems and adequate with the risks encountered.
5.4 CAPAER: It is defined as a review performed after completion of a CAPA activity to evaluate the
effectiveness in reducing the potential for future incidents or non- conformance.

6.0 PROCEDURE:
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Quality Assurance SOP No.:
Title: Corrective action and Preventive Action (CAPA) Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

6.1 All the non-conformities occurring in procedures like Handling of Deviations in Facility, Standard
Operating Procedures, BMR & BPR, Standard Test procedures/Specifications, Self Inspection, Change
Control; Handling of Market Complaints; Product Recall; Incidents; Annual Product Review; Trend
analysis; Handling of Raw material, Packaging material, In-process/Semi-finished and Finished products;
consignment received from vendors, etc. shall be addressed through CAPA.
6.2 Initiating department shall raise the request to QA for issuance of Corrective and Preventive Action Form in
the Format, Titled “Request Form for Issuance of Documents” of SOP, Titled “Procedure for
Documentation & Data Control”.
6.3 Officer/Executive QA shall assign a CAPA number in “Corrective Action and Preventive Action Record”
as shown in Annexure-II and same number shall be entered in “Corrective Action and Preventive Action
Form” as shown in Annexure-I.
6.4 Assignment of CAPA Number:
CAPA/YY/NNN
Where,
CAPA: Denotes Corrective Action and Preventive Action
/ : separator
YY : Last two digits of the Calendar Year
/ : separator
NNN : Serial Number of the CAPA raised in current Calendar Year.

6.5 INVESTIGATION AND CAPA PROPOSAL:

6.5.1 The Initiator of Concerned Department shall write the Description of Non conformities and perform
Investigation in consultation with Head of Initiating Department as per SOP, Titled ‘Root Cause
Analysis’ and if applicable, RCA No. shall be recorded in CAPA Form.
6.5.2 The Concerned Department Head along with QA and other cross functional Department shall
thoroughly investigate the root cause of non-conformities related to Facility/Process/Software/
Equipment/Instrument/Documents/System/Utility/Product.
6.5.3 Initiator of Concerned Department shall mention the investigation finding of non-conformance in
CAPA which shall be further reviewed by Head of Initiating Department along with sign & date.
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Quality Assurance SOP No.:
Title: Corrective action and Preventive Action (CAPA) Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

6.5.4 Concerned Department shall determine CAPA action plan to eliminate the causes of potential non
conformities and / or encountered non-conformities in order to prevent their occurrence and / or
recurrence.
6.5.5 Investigation shall be extended to other batches also that may be associated with specific failure or
non-conformities and shall enter the detail in CAPA form for investigation findings.
6.5.6 Initiating Department Head shall assign the proposed Corrective Action and Preventive Action
against the root cause findings along with sign and date of responsible department and target
completion date.

6.6 IMPACT ASSESSMENT OF PROPOSED CAPA :

6.6.1 Manager QA shall further review the proposed CAPA and give comments for Impact assessment
related to Proposed CAPA along with sign and date.
6.6.2 Impact assessment of recommended CAPA on other batches, similar existing system, documents,
other products, validated processes, on-going stability studies and testing procedures etc. shall be
determined by user department in-consultation with CAPA Manager QA and shall be recorded in
CAPA Form.

6.7 APPROVAL OF CAPA:

6.7.1 After receiving the review comments from Manager QA, final assessment of CAPA shall be done by
Head QA for Approval or Rejection with sign and date.
6.7.2 After approval of Proposed CAPA, the proposed CAPA action plan shall be implemented by the
Initiating Department.
6.7.3 In case of Approval / Rejection, CAPA Form shall be submitted to QA and same shall be
Logged by QA with sign and date in “Corrective Action and Preventive Action Record” as
Shown in Annexure-II.
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Quality Assurance SOP No.:
Title: Corrective action and Preventive Action (CAPA) Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

6.8 POST IMPLEMENTATION EVALUATION & CLOSURE OF CAPA:

6.8.1 Post Implementation results of CAPA shall be compiled by Concerned Departments and shall be
reviewed by Manager QA for its Implementation and completion along with review of documents
and give comments for the Evaluation of CAPA along with sign and date.
6.8.2 CAPA shall be closed within 30 calendar days from date of Approval.
6.8.3 After post implementation evaluation of CAPA, Manager QA & Concerned Department Head shall
sign and date for closure of CAPA.
6.8.4 Head QA shall further review the post implementation evaluation of CAPA for its correctness and
completeness and shall close the CAPA with sign & date. Date of closure shall be mentioned by
Head QA in CAPA form.
6.8.5 If proposed Corrective & Preventive Action(s) not achieved till target date then date shall be
revised/extended after approval from Head QA and shall be documented in “Extension
Justification for CAPA Closure” as shown in Annexure-III & respective Customer/Regulatory
Agency shall also be informed.
6.8.6 The Extension Justification shall be Approved/Rejected by Head QA based on justification and revised
Target Completion Date.
6.8.7 Any change proposed as a result of CAPA shall be through the current version of SOP “Change
Control Management” SOP. Reference of the same shall be mentioned in the CAPA.

6.9 CAPA EFFECTIVENESS REVIEW:

6.9.1 After Closure of CAPA, it shall be reviewed to check the CAPA effectiveness.
6.9.2 CAPA effectiveness review date shall be 3 months from the closure date of CAPA, it shall be given
by Head QA.
6.9.3 Effectiveness Review shall be done for the followings:
6.9.3.1 Repetition of the same non-conformance.
6.9.3.2 Occurrence of any other non-conformance which has the same root cause.
6.9.3.3 Any other impact of CAPA on systems which was previously not assessed.
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Quality Assurance SOP No.:
Title: Corrective action and Preventive Action (CAPA) Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

6.9.4 Flow chart for Corrective & Preventive Action is shown in Annexure-IV, Titled “Flow Chart for
Corrective Action & Preventive Action”.
6.9.5 Head QA shall give comments for CAPA effectiveness check along with sign & date for final
closure of CAPA.
6.9.6 After Effectiveness review from Head QA, CAPA shall be closed by QA and same shall be
documented in the CAPA Logbook and a photocopy reference copy shall be enclosed with
respective Deviation, Batch Manufacturing Record, Batch Production Record, Internal Audit report,
Change Control, Market Complaint, Product Recall and Incident Report etc.

6.10 CAPA TRACKING:

6.10.1 Tracking Corrective Actions and Preventive Actions shall be performed by respective QA
Personnel.
6.10.2 For tracking, respective CAPA form and log shall be reviewed on regular basis by respective QA
Personnel.

7.0 ABBREVIATIONS:
CAPA Corrective Action & Preventive Action
cGMP Current Good Manufacturing Practices
Ltd. Limited
No. Number
Pvt. Private
QA Quality Assurance
SOP Standard Operating Procedure

8.0 ANNEXURES:
ANNEXURE No. TITLE OF ANNEXURE FORMAT No.
Annexure-I Corrective Action & Preventive Action Form

Annexure-II Corrective Action & Preventive Action Record

 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Quality Assurance SOP No.:
Title: Corrective action and Preventive Action (CAPA) Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

Annexure-III Extension Justification for CAPA Closure

Annexure-IV Flow Chart for Corrective Action & Preventive Action

9.0 DISTRIBUTION:
 Master Copy Quality Assurance Department
 Controlled Copy No. 01 Quality Assurance Department.
 Controlled Copy No. 02 Quality Control Department.
 Controlled Copy No. 03 Production Department.
 Controlled Copy No. 04 Warehouse Department.
 Controlled Copy No. 05 Engineering Department.
 Controlled Copy No. 06 Personnel & Administration and Human Resources Department.
 Controlled Copy No. 07 Information and Technology Department.

10.0 REFERENCES:
 Draft Guidance to “WHO Deviation Handling and Quality Risk Management”; A note for guidance
for the manufacture of prequalified vaccines for supply to United Nations agencies, July-2013.
 Guidance for Industry, “Quality Systems Approach to Pharmaceutical cGMP Regulations”,
September 2006.
 21 Food and Drugs Chapter I, Food and Drug Administration Department of Health and Human
Services Subchapter H -Medical Devices; Part 820 - Quality System Regulation, Subpart J,
Corrective and Preventive Action.

11.0 REVISION HISTORY:

Revision Change Control Details of Changes Reason of Effective Date Done By
No. No. Changes
00 Not Applicable Not Applicable New SOP
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Quality Assurance SOP No.:
Title: Corrective action and Preventive Action (CAPA) Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

ANNEXURE-I
CORRECTIVE ACTION AND PREVENTIVE ACTION FORM

CAPA No. : Department :

Date : CAPA Initiated by :

CAPA recommended as per 

Deviation No. : OOS No. :
Incident No. : Self Inspection :
Market complaint No. : Trends analysis :
Product recall : Annual Product Review :
Any other (Specify) :
Description of Non-Conformity

RCA : Applicable Not Applicable

If Applicable, RCA No.:

Initiator
Sign/Date:

Investigation Findings:

Initiator: Review by: Head of Initiating Department

(Sign/Date) (Sign/Date)

CAPA Action Plan

Sr. No. Corrective Actions Responsible Sign & Date Target Completion
Department Date

Sr. No. Preventive Actions Responsible Sign & Date Target Completion
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Quality Assurance SOP No.:
Title: Corrective action and Preventive Action (CAPA) Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

Department Date

* Attach separate sheet if required

Impact Assessment of the Proposed CAPA:
Review Comments:

Manager QA
Sign/Date:

Head QA
Approval or Rejection of CAPA action plan Sign/Date
Tick mark ( / X):
Approved Rejected

Post Implementation Evaluation of CAPA (By Manager QA):

Review Comments:

Sign/Date:

Closure of CAPA action plan Sign/Date

Initiator Department Head

Manager QA

Head QA

CAPA Close out Date:

Effectiveness Review:

CAPA Effectiveness Review Target Date:

 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Quality Assurance SOP No.:
Title: Corrective action and Preventive Action (CAPA) Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

Review Comments after CAPA Effectiveness check (By Head QA):

Sign/Date:
CAPA Report Closure by QA after Effectiveness Review:

CAPA Closed On:

Name: Sign: Date:

 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Quality Assurance SOP No.:
Title: Corrective action and Preventive Action (CAPA) Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

ANNEXURE-II
CORRECTIVE ACTION AND PREVENTIVE ACTION RECORD

Target Completion Date of

Effectiveness review by QA
Description of Non
CAPA Issued By

Close Out By QA
CAPA Approved/

(Sign &Date)
(Sign & Date)

(Sign & Date)

Department

Conformity
Concerned

Reference
CAPA No.

Rejected
Doc. No.

CAPA

CAPA
S .No.

Date
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Quality Assurance SOP No.:
Title: Corrective action and Preventive Action (CAPA) Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

ANNEXURE-III
EXTENSION JUSTIFICATION FOR CAPA CLOSURE
Date:
Department:
Reference CAPA No.:
Previous Due Date for CAPA:
New Target Completion Date:

JUSTIFICATION DETAILS
Open identified action of CAPA:
Justification:

Impact of delay:

Initiated By: Reviewed By: Head Initiating Department

(Sign & Date) (Sign & Date)

Approval / Rejection by Head QA: (Mark Tick √/x on applicable ) Approved Rejected
Review Comments:

Name: Sign: Date:

 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Quality Assurance SOP No.:
Title: Corrective action and Preventive Action (CAPA) Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

ANNEXURE-IV
FLOW CHART FOR CORRECTIVE ACTION & PREVENTIVE ACTION

Initiation of Corrective Action & Preventive Action

(CAPA) from Concerned Department

Issuance of CAPA Form from QA to Concerned

Department with CAPA No.

Investigation & RCA (If Applicable) of Non-conformity by Initiation of CAPA Action Plan
Concerned Department, QA & other related Department by Concerned Department &
other related Department

Approval/Rejection by Head QA Review of Impact Assessment of

CAPA Action Plan by Manager QA
Corrective & Preventive Action
Implementation
Document the CAPA details in
CAPA Record by QA
Post Implementation review of CAPA by Manager QA

Closure of CAPA by Initiator Dept. Head, Manager QA &

Head QA
CAPA Report closed after
CAPA Effectiveness Review by Head QA effectiveness review by Head QA