Guideline for CAPA (Corrective and Preventive Action) handling procedure
PURPOSE
To define the procedure for handling of Corrective and Preventive Action.
SCOPE
This guideline is applicable for all Corrective and Preventive Action that are recommended if any,
but not limited to the following documents:
Incident / Deviation – Investigation
Change control
Laboratory deviations
Repeat analysis
OOS
Planned Modification
Market complaints
Documents review (SOP/BMR/Specification)
Audits (Internal / External)
Regulatory recommendations
REFERENCE(S) & ATTACHMENTS
References
WHO Guideline :TRS -908 :Annexure-4: Good manufacturing for pharmaceutical product: main principles
PIC’s Guideline : Guide to good manufacturing practice for medicinal products (PE009- 09) Part-I
Attachments
Attachment –I : Corrective and Preventive Action form issuance register
Attachment – II : Corrective and Preventive Action Form
Attachment –III : Flow Chart of CAPA
Annexure –I : Manufacturing unit code
DEFINITION & ABBREVIATION(S)
Definitions
Corrective and Preventive Action (CAPA):
CAPA focuses on the action taken on discrepancies (failures and/or deviations) in an attempt to prevent their recurrence (for corrective action) or to prevent occurrence (for preventive action).
Corrective Action:
Action taken to prevent the recurrence of any discrepancies (failures and/or deviations) or non-conferment or undesirable incident.
Preventive Action:
Action taken to prevent the occurrence of any discrepancies (failures and/or deviations) or non-conferment or undesirable incident.
Abbreviations
OOS: Out Of Specification
CAPA: Corrective and Preventive Action
QA : Quality assurance
QC : Quality control
CQA: Corporate Quality Assurance
BMR : Batch manufacturing record
SOP : Standard operating procedure
RESPONSIBILITY
Concerned Department Person:
To implement the Corrective and Preventive Action.
Quality Assurance:
To assign the Corrective and Preventive Action that are suggested by the approving authorities through Corrective and Preventive Action form.
To assign a number to the Corrective and Preventive Action (CAPA) form.
To issue the CAPA form.
To follow up and close of the Corrective and Preventive Action after review.
To evaluate and close the CAPA on completion Concerned Department Head:
To implement the Corrective and Preventive Action
To complete the CAPA as per defined schedule.
Quality Assurance /Quality Control (QA/QC) Head:
To ensure tracking, follow – up and closure of Corrective and Preventive Action.
To provide extension approval of the target date.
To ensure implementation of defined system
Location Head:
To ensure tracking, follow – up and closure of Corrective and Preventive Action.
To ensure implementation of defined system
PROCEDURE
After review of approved documents (i.e. incidence /Deviations report investigation report, change controls , Laboratory variations reports ,repeat analysis reports, OOS reports,Planned modification, Market complaints, external audits, internal audits) where ever Corrective and Preventive Action are suggested, QA person shall enter such details into CAPA form issuance register (Attachment –I).This CAPA form issuance register shall have following details.
Sr no .: The sequential number of the CAPA shall be written.
Date : The date on which the CAPA is assigned.
CAPA No. : CAPA Number shall be entered into this column and numbering procedure described below.
Reference document no: The document reference number in the context of which above CAPA is assigned.
Recommendation: The recommendations to be implemented.
Responsible Person: The person responsible for the Implementation of CAPA.
Responsible department: The department responsible for the Implementation of CAPA.
Target date: The target date to fulfill the recommendations.
Extended target date: If any extended target date to fulfill the recommendations.
Justification for extension of target date: Fill the justification for extension of target date to fulfill the recommendations.
Status: On the basis of the fulfillment of the ‘status’ whether ‘open’ or ‘close’ shall be determined.
Remarks: Remarks shall be written if any.
Based on the CAPA register entries a CAPA form (Corrective and Preventive Action form Attachment-II) shall be issued to concerned department. Details of CAPA issuance procedure is described below.
Concerned department head shall be responsible to complete the CAPA as per requirement and within defined time schedule.
For proper traceability CAPA No. shall be entered into subjected document from where CAPA is initiated.
For each document a separate CAPA number shall be assigned for traceability and tracking for example Temporary change control No, Permanent change control, Audit Report,Market complaint No. Planned modification No., incident Report No. etc.
A typical numbering system shall be:
Note : If CAPA to be taken for Different documents is same then one common CAPA No. can be Issued.
First four characters shall be the prefix CAPA followed by a slash (/).
Next two characters shall comprise of the manufacturing unit code.
Next three characters shall comprise of the department code succeeded by last two digits of the current year followed by a slash (/). (Like 22 for year 2022,23 for year 2023 and so on…).
Last three digits shall be the serial number beginning with 001 and shall start with 001 from 1st January of each year.
For example: First CAPA of the Production department for the year 2022 shall be numbered as CAPA/ PRD22/001.
For each CAPA the CAPA form shall be issued by QA to concerned department by whom necessary action will be taken to implement the recommendation. The Corrective and Preventive Action Form shall be issued to the concerned department.(Department code shall be as per defined in SOP on SOP)
Following details will be filled in Corrective and Preventive Action form. (Attachment-II)
Department: Name of concerned department to whom CAPA is issued
Issued by: Name of the QA representative by whom CAPA form is issued.
CAPA No.: The CAPA form is assigned a sequential number.
Target date: QA shall fill the target date in consultation with the concerned department.
Any extension in target date shall be authorized by the QA/QC Head or designee by striking out the previous target date and countersigning and writing the extended date in the next column with justification.
CAPA recommended as per: Reference of the document no. against which the CAPA is issued shall be documented.
Details of recommendation /Action: The recommendations/action of the respective documents shall be written in the CAPA Form.
Responsible person: The name of the responsible person for completion of the recommendations shall be written in consultation with the concerned department head by QA.
After filling the above details CAPA form shall be forwarded to concerned department for the implementation of the recommendation.
Upon completion of the recommended activity concerned department shall write down the details of action taken along with supporting data, if any after verification from department head or designee;
The person performing the assigned CAPA shall sign in the performed by column and the respective person of the concerned department verifying the above action shall sign in the verified by column.
After completion of above activity the duly filled and signed CAPA form shall be submitted to QA department for evaluation.
QA/QC head and location head shall finally review and approve the CAPA for final closure.
Any supporting data attached with the CAPA form shall be evaluated by QA. On the basis of evaluation CAPA issuance register shall be updated for the status.
After evaluation the concerned QA person shall sign in evaluated by column.
During evaluation if any shortcomings are found it shall be returned to concerned department with extended target date after authorization.
The Status of open CAPA No. shall be circulated to concerned departments on monthly basis.