Direct Links to important GMP Inspection & Auditing Guidelines

Auditing Guide - Annex 3 – Audit Report Template

This template provides a standard for reports fo audits conducted within the framework of the APIC Audit Program.

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Requirements for Medical Device Auditing Organizations for Regulatory Authority Recognition

In the past, various Regulatory Authorities have identified shortcomings in the standards being utilized for the recognition of organizations that conduct medical device audits for regulatory purposes. These standards were considered to be too generic and focused on commercial entities for commercial purposes. However, many organizations that work in the regulated environment of medical devices must comply with these generic requirements for other purposes.

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Registered Starting Material Auditing Guide - Annex 1 - Aide Mémoire

This documents can be used as a checklist during audits at starting materials manufacturers.

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GMP Conferences by Topics

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