Guideline for CAPA (Corrective and Preventive Action) handling procedure

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.

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