Direct Links to important GMP Inspection & Auditing Guidelines

APIC - Guide for auditing Registered Starting Material manufacturers

This document is intended to give guidance on auditing manufacturers of registered starting materials.

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Annex 1 - Contract between Auditor and the API Compliance Institute

Contract between Auditor and the API Compliance Institute.

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Annex 2 - Agreement on Audit Execution

Agreement on audit execution between customer, auditee, auditors and API Compliance Institute.

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Annex 3 - Secrecy Agreement

Secrecy Agreement between customer, auditee, auditors and API Compliance Institute.

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Standardised Letters related to Shared 3rd Party Audits: Letter 1 - Letter to the Manufacturing Authorisation Holder

Standardised Letter to the Manufacturing Authorisation Holder

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Standardised Letters related to Shared 3rd Party Audits: Letter 2 - Letter to the API Manufacturer

Standardised Letter to the API Manufacturer

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Standardised Letters related to Shared 3rd Party Audits: Letter 3 - Letter from the API Manufacturer to the customer

Standardised Letter from the API Manufacturer to his customer

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Annex 5 - Feedback Form

Feedback form for auditee regarding audit performance

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The Joint IPEC-PQG Good Manufacturing Practices Audit Guideline 2008

This document provides standards for audits in Excipients production sites

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The IPEC Good Distribution Practices Audit Guideline 2011

This document describes standards for Good Distribution Practice Audits of pharmaceutical excipients.

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GMP Conferences by Topics

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