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.

Annex 1 - Contract between Auditor and the API Compliance Institute

Contract between Auditor and the API Compliance Institute.

Annex 3 - Secrecy Agreement

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

Standardised Letters related to Shared 3rd Party Audits: Letter 1 - Letter to the Manufacturing Authorisation Holder, Letter 2 - Letter to the API Manufacturer, Letter 3 - Letterfrom the API Manufacturer to the customer

Standardised Letter to the Manufacturing Authorisation Holder

Annex 5 - Feedback Form

Feedback form for auditee regarding audit performance

The Joint IPEC-PQG Good Manufacturing Practices Audit Guideline 2008

This document provides standards for audits in Excipients production sites

The IPEC Good Distribution Practices Audit Guideline For Pharmaceutical Excipients 2021

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

Quality Management System – Medical Devices – Guidance on the Control of Products and Services Obtained from Suppliers

This guidance document is intended for medical device manufacturers and it is expected that the reader is familiar with regulatory quality management system requirements within the medical devices sector. This guidance document may also be useful to regulatory authorities and suppliers. This guidance document is intended for educational purposes and it is not intended to be used to assess or audit compliance with regulatory requirements.

Guidelines for Regulatory Auditing of Quality Management Systems of Medical DeviceManufacturers Part 3: Regulatory Audit Report

This document gives guidance to regulators, auditing organizations and auditors on the content of audit reports. However, it may also help the auditee understand and respond to the audit findings.

Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers Part 4: Multiple Site Auditing

This document gives guidance to regulators and auditing organizations conducting audits of quality management systems of medical device manufacturers with multiple sites. This document should be read in conjunction with the Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers -- Part 2: Regulatory Auditing Strategy (GHTF/SG4/N30).

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