This procedure pertains to GMP operations, personnel and areas as well as to raw materials, excipients or components, intermediates, drug products, drug substances and medical devices.

The CAPA system will also be used to track and trend corrective and preventative actions planned to address known issues and actions or to implement quality improvements.

This may include, but is not limited to:

• Deviations/Non-conformance, OOS – Procedure
• Product Complaints – Procedure for Handling Product Complaints
• Returned Products
• External and internal audit observations / assessments
• Annual Product Reviews – Annual Product Review
• Regulatory Issues
• Management Review proposals
• Any issues that require mid-term and long-term corrective or preventative action, with formal tracking and documentation
• Recommendations of executed validations
• Quality Events/Improvements
• Supplier Quality feedbacks and assessments

Regulatory basis, reference documents for this CAPA SOP

FDA: 21 CFR 210, 211, 600, and 820

EMA: ICH Q10 (Pharmaceutical Quality System)

CAPA SOP Table of Content:

1 Purpose

2 Objective

3 Regulatory basis, reference documents

4 Responsibility and accountability

4.1 Company Management

4.2 Quality Management Representative/ Quality Assurance

4.3 Other Departments

5 Related documents

6 Definitions

7 Procedure

7.1 General

7.2 Start of a CAPA

7.3 CAPA Numbering

7.4 CAPA Investigation

7.5 CAPA Route Cause

7.6 Corrective and Preventive Action Plan

7.7 Completion of CAPAs

7.8 Trending of CAPAs

7.9 Reporting of CAPAs

7.10 Archiving

8 Attachments

8.1 Attachment 1: Corrective and Preventive Action Form (2 pages)

8.2 Attachment 2: Request for Extension of CAPA Completion Date (2 pages)

8.3 Attachment 3: Flowchart CAPA (1 page)

9 SOP distribution

10 Health, safety and environmental considerations

Size and Format of SOP:

Microsoft Office

Word File

15 pages procedure

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