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ORGANIZATION NAME Approved date:

Effective date:
Title: Standard Operating Procedure for Corrective and Preventive Revision No. 00 Page 1 of 13

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Title: Standard operating procedure for corrective and preventive action Logo

Status: SOP N o .

o.
Prepared by Approved by Revised by Version N
Name: Name Name Effective date:

Sig: Sig: Sig: Review date:

Date: Date: Date: Supersedes:

Disclaimer: This is a model standard operating procedure. It incorporates generic

guidance principles only. Firms are encouraged to adapt their own SOPs as necessary to
suit their in-house procedures.
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Table of Contents

1 Introduction...................................................................................................................3

2 PURPOSE..................................................................................................................... 3

3 SCOPE.......................................................................................................................... 3

4 Acronyms:.....................................................................................................................3

5 Responsibility................................................................................................................3

6 Definition...................................................................................................................... 4

7 Procedures..................................................................................................................... 5

8 Distribution....................................................................................................................9

9 Revision history.............................................................................................................9

10Annexures.........................................................................................................................9

11References........................................................................................................................ 9

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1. Introduction

Corrective and Preventive actions are taken when deviations or nonconforming work
from the policies and procedures in the management system or technical operations have
been identified. The root cause investigation process will provide objective evidence to
implement corrective and possibly preventive actions as part of the CAPA system.
2. Purpose

The purpose of this SOP is to lay down the procedure for the initiation, evaluation,
approval, implementation, tracking, effectiveness and verification of effectiveness of
corrective and preventative actions, closure.

3. Scope

This SOP applies to all concerned departments of [ X pharmaceutical

Facility] 4. Acronyms:

APQR Annual Product Quality Review

CAPA Corrective and Preventive Action

HOD Head of Department

OOT Out of Trend

OOS Out of Specification

QA Quality assurance

SOP Standard Operating Procedure

5. Responsibility

 Initiating department: responsible to initiate CAPA whenever there is non-

conformity work

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 Respective department: Responsible to initiate, rectify non- conformity work

accordingly.
 Quality assurance unit (QA approver, QA reviewer, QA closure)/ Technical
manager/ general manager/CEO)
- Responsible to approve completeness, adequacy and, review
- Responsible to assure necessary corrective and preventive action are taken
and close the CAPA.
 Cross functional team: responsible to perform the recommended activity and
attach supporting documents.
6. Definition

6.1. Corrective and preventive action (CAPA): CAPA is a tool of quality

management system of implementation of corrective and preventative actions
resulting from the investigation of incident/recall/component rejection/out of
specification/change control/market compliant/internal or external audit
observation/Annual product quality review/regulatory compliance action/non-
compliance report/risk analysis/validation summary report.
6.2. Corrective Actions are taken to eliminate the root causes of deviations, and
should be based on good quality investigations.
6.3. Preventative action: Pro-active in nature which is action executed to eliminate
the cause of potential non-conformity and implemented independently from the
occurrence of deviations (Preventive action i.e. act on potential deviation) and
prevent occurrence.

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7. Procedures

7.1. General CAPA management

7.1.1. All the corrective and preventative actions that are finalized as part of the respective system or
procedure shall be monitored through the CAPA management SOP.
7.1.2. Each department shall initiate their respective finalized CAPA’s as per the annex II
below.
7.1.3. All CAPA’s total time line period from initiation to closure shall not exceed 180
working days.
7.1.4. The time period from initiation to approval of the CAPA is 30 working days, 60
working days from approval of CAPA to closure of CAPA, 90 working days for
extension of closure.
7.1.5. Any supporting documents wherever required, has to be attached in their original
template or format, signed off and attached to CAPA initiated as applicable.

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1.1Intiation of CAPA

1.1.1 CAPA initiated in theinvestigation Incidents,OOS, OOT, Market compliants,

deviations, component rejections, change controls, internal audits , external audits,
validation, product recall, product quality review, risk analysis,or regulatory
compliance and informed to the concern person from the intiating department by
[QA personnel] (Equivalent personnel) responsible for the coordination of
CAPA.

1.1.2 The responsible person from the intiating department intiate the CAPA as per the
Annexure 2.

1.1.3 The CAPA intiator shall fill in the below given details in the template (Annexure
II) and forward the same to the HOD or designee.

1.1.4 Evaluation of CAPA by HOD of designee of intiator department

1.1.5 In case of any discrepancy observed, the HOD or his designee shall send back the
CAPA temepate for the intiator for corrections.

1.1.6 The initiatorrectifies the discrepancy and send back to HOD for review and
approval.

1.1.7 The HOD forwards the filled Template to QA approval for review and approved
the CAPA.

1.2 Review and Approval of CAPA by QA approver:

1.2.1 The QA approval review the CAPA for the completeness, adequacy and accuracy

1.2.2 On review of the above, the QA approver, approve the CAPA and sign off.

1.2.3 In case of any discrepancy noticed, the same shall be returned to both the initiator
and HOD for rectifications.

1.2.4 On rectifications of the discrepancies, the initiator shall forward the CAPA to the
HOD for the approval.

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1.2.5 Up on approval by the HOD, QA-Approver shall review and approve the same.

1.2.6 On approval of CAPA, the QA-approver shall assign the CAPA number and the
CAPA number should be generated on logical order.

1.2.7 On approval, the QA Approver shall inform the concerned person of the initiating
department for the execution of the CAPA.

1.3 Execution of CAPA (Individual department and cross functional team)

1.3.1 The Initiator and concerned department perform the recommended activity and
attach the supporting document (if any) as mentioned in the CAPA temperate.

1.3.2 Any change in the existing systems, procedures or documents required based on
the recommended CAPA, shall be routed through SOP of change control.

1.3.3 If CAPA is related to certain department, the recommendations or action taken

shall be communicated to the respective departments.

1.4 Review of CAPA implementation by QA Reviewer

1.4.1 On completion of the implementation activity by the initiating department, the

QA reviewer review the implementation activities for the CAPA and supporting
documents of each department for the completeness, accuracy and adequacy.

1.4.2 In case any discrepancy noticed, send CAPA back to the respective initiating or
the cross function department for rectifications.

1.5 The initiating or cross functional department complete the rectifications and
send back the CAPA format to the QA reviser.

1.5.1 QA reviewer, review the same and sign off.

1.5.2 On successful review, the QA reviewer inform for CAPA effectiveness check to
the concerned department.

1.6 CAPA effectiveness verification by individual or cross functional

departments

1.6.1 Each department that has been assigned the CAPA implementation carry out the
effectiveness verification for their respective CAPA implemented.

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1.6.2 Once done, each department attach any supporting documents against the
respective CAPA format and sign off.

1.7 Review of Effectiveness verification by QA Reviewer

1.7.1 On completion of the effectiveness verification activity by the initiating

department or the cross function team, the QA Reviewer review the effectiveness
verification and supporting documents for each department for completeness,
adequacy and accuracy.

1.7.2 In case discrepancy noticed, the same shall be informed to the respective cross
functional department for rectifications and the cross functional team shall
complete the rectification and send back CAPA template to QA reviewer

1.7.3 The QA reviewer, review the same and sign off.

1.8 Closure of the CAPA by QA closure

1.8.1 Based on the review by the QA reviewer, QA closure, close the CAPA with
comments and sign off.

1.9 Extension of the CAPA closure

1.9.1 If activities related CAPA are not executed within 60 working days, in such case
initiating department head shall request for extension with justification along with
proposed date for completion of the same.

1.9.2 Period implementation of CAPA and further extension shall be proposed based on
the risk assessment of existing process and impact on product quality.

1.9.3 QA approval shall review the reason and approve/reject the extension by signing
off.

1.9.4 On approval, the CAPA closure shall be extended by not exceeding by 90 working
days or can be with appropriate Justification of extension.

1.10 Review and Trending of CAPA

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1.10.1 CAPA shall be reviewed by quality assurance every two weeks for its status, the
details for the same shall be provided to concern HOD, CEO and concerned
higher officials.

1.10.2 QA prepared Trends of CAPA on periodical basis by means of graphs/charts

including details of type and category and information.

2 Distribution
This SOP will be distributed to:

 Technical manager office

 All concerned departments
 Original copy: Quality assurance/Managing director

3 Revision history

Revision Summary of change Effective date

number
R0 New SOP To be assigned
R1
R2

4 Annexures
 Annexure 1: CAPA log
 Annexure 2: CAPA format

5 References
 World Health Organization: deviation handling and quality risk management
 ISO13485: Quality management System

Annexure 1: CAPA log

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Date Product/system Tracking ref.No Reference Description Status Verifie

/Area of parent d/
Corrective Preventive Inv. format Corrective Preventive sign/da
action action Action action te
1.

2.

3.

Annex 2: CAPA Format

CAPA initiation
Source of information
CAPA No: Date:
Problem/observation/Information is related to:
 Equipment/process/vendor/material/ storage/warehouse/ distribution/….
 Feedback from regulatory agency/marketing/ managing directors
 Internal /external audit
 Any other source

Reference Document Number:

Brief description of parent document

Root cause summary:

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Descriptive of corrective action:

Descriptive of preventive action:

Department: Initiated by: date

Review of the CAPA by HOD (head of department)

Review of CAPA ( comments)

Name: sign/date:
Approval of CAPA by QA
Review of comments

Name: sign/date:
CAPA implementation by initiating department
Corrective Action implemented:

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Preventive action Implemented:

Reference document attached:

CAPA implemented by:

Name: sign/date
Review of CAPA implementation by QA
Review of corrective action implementation:

Review of preventive Action implementation:

Reviewed by Quality assurance:

Name: sign/date
Effectiveness check of the implemented CAPA by department
Effectivenesscheck comments

Effeteness check by:

Name: sign/date
Effectiveness check by QA

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Effectiveness comment by QA

Checked by:

Extension of CAPA closure

Reason/ Justification of extension:

Approval of extension of closure:

Comments

Review and closure of CAPA

Comments

CAPA closed by: sign/ date