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CAPA Procedure SOP for Quality Assurance

This two-page document outlines Coral Laboratories' procedure for corrective and preventive action (CAPA). It includes a form to propose and approve CAPAs, with fields for the source of observation, reference documents, proposed action, target completion date, responsibilities, and review/approval. It describes completing the CAPA, verifying implementation, assessing impact, and closing the action. The procedure aims to ensure proper handling of deviations, complaints, risks, audits, and other issues through corrective and preventive measures.

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QA Doon
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179 views2 pages

CAPA Procedure SOP for Quality Assurance

This two-page document outlines Coral Laboratories' procedure for corrective and preventive action (CAPA). It includes a form to propose and approve CAPAs, with fields for the source of observation, reference documents, proposed action, target completion date, responsibilities, and review/approval. It describes completing the CAPA, verifying implementation, assessing impact, and closing the action. The procedure aims to ensure proper handling of deviations, complaints, risks, audits, and other issues through corrective and preventive measures.

Uploaded by

QA Doon
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd

CORAL LABORATORIES LIMITED

Plot No 27-28, Pharmacity, Selaqui, Dehradun 248197 (Uttarakhand)

Department: Quality Assurance SOP No. SOP/QA/071


Revision No. R-02
Subject: Procedure for CAPA
Page No. 1 of 2
Annexure-I
CORRECTIVE ACTION AND PREVENTIVE ACTION FORM
Source of Observation (Select as Applicable)
Deviation/Market Complaint/Risk Assessment/External Audit/OOS/Incident/Other (Specify):_______________
_______________________________________________________________________________________
Reference Document No.:
Raised By(Department):
Proposal & Approval of Corrective and Preventive Action
Proposed CAPA:

Target Date of Completion:


Responsibility:

Proposed By Initiating Department Other Department Checked By HOD


Sign & Date Sign & Date Sign & Date

CAPA No.: Assigned By Sign & Date:

CAPA Review and Approval


Remark:

Reviewed & Approved By Head QA/Designee:


Name:_____________________________ Sign & Date:_____________
CAPA Implementation
Date of Completion:
Prepared By Checked By Approved By Issued By
Signature
Date
CORAL LABORATORIES LIMITED
Plot No 27-28, Pharmacity, Selaqui, Dehradun 248197 (Uttarakhand)

Department: Quality Assurance SOP No. SOP/QA/071


Revision No. R-02
Subject: Procedure for CAPA
Page No. 2 of 2
Enclosures of CAPA(Attach reference documents as an evidence):

Completed by User Department: Name:____________________________ Sign & Date:____________

Implemented CAPA Verified By QA Sign & Date:________________


Impact Assessment of Implemented CAPA & Closer
Remark:

Reviewed & Closed By Head QA/Designee:


Name:_________________________ Sign & Date:______________
Final Submission:

Reviewed By QA (Sign & Date):_______________________

Prepared By Checked By Approved By Issued By


Signature
Date

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