Standard Operation Procedures

Corrective and preventive action (CAPA)

Standard Operation Procedures
100,00 EUR
app. 132.00USD
(Non-german customers)

119,00 EUR
(German customers incl. 19% tax)



FDA
EMA
What you will get:
Delivery item: Word Document
You will be able to enter your data into the Word document.
Please note: We do not deliver hard copies.
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Description of the Standard Operation Procedures - Corrective and preventive action (CAPA)

Governmental agencies in the pharmaceutical sector, such as the FDA, are challenging companies on an increasingly regular basis as regards their corrective and preventive action (CAPA) systems. Their aim is to ensure that deviations/non-conformance, product complaints, external and internal audit observations, annual product reviews, recommendations and regulatory issues are identified, fully investigated to their root cause and properly assessed.

This Standard Operating Procedure (SOP) is ready to use and meets all the expectations of cGMP agencies as regards CAPA systems. The 6-page SOP, which includes 2 attachments, needs only site-specific modification before it can be used for your operations.

Table of Content

1. Regulatory Basis, Reference Documents
2. Purpose
3. Scope
4. Responsibilities and Accountabilities
4.1 Responsible Area Manager
4.2 Quality Assurance
5. Procedure
5.1 Initiation of CAPA
5.2 CAPA Numbering System
5.3 Corrective and Preventive Action Plan
5.4 Request for Extension of Completion Date
5.4 Reporting
5.4.1 Reporting of open CAPAs
5.4.2 Reporting of closed CAPAs
5.4.3 Archiving
6. Definitions
7. Distribution
8. Attachments
Attachment 1: Corrective and Preventive Action Form
Attachment 2: Request for Extension of CAPA Completion Date

Corrective and preventive action (CAPA)
100,00 EUR
Additional 19% tax for customers from Germany
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