Direct Links to important GMP API Guidelines

APIC - Quality Management System (QMS) for Active Pharmaceutical Ingredients (API) Manufacturers - Integrating GMP (ICH Q7a) into ISO (9001:2000), September 2005

This document gives detailed guidance for implementing a QMS and provides a standard for API manufacturers.

FDA Guidance for Industry: Process Validation: General Principles and Practices

This guidance outlines the general principles and approaches that FDA considers to be 21 appropriate elements of process validation for the manufacture of human and animal drug and 22 biological products, including active pharmaceutical ingredients (API or drug substance),

Eudralex Volume 3 Guideline on the quality of water for pharmaceutical use

Guidance on the pharmaceutical use of different grades of water in the manufacture of APIs and medicinal products

APIC - Quick Guide for API Sourcing, 2008

This document focuses on the interaction between the API manufacturer and the medicinal product manufacturer and provides possible measures that may be taken by both partners in order to ensure only non-rogue APIs are used in the manufacture of medicinal products.

PIC/S Aide Memoire on INSPECTION OF ACTIVE PHARMACEUTICAL INGREDIENTS (PI 030-1)

Guide for inspectors for preparing an inspection of an API facility and the API production.

FDA Guidance for Industry: Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions Annex 11: Capillary Electrophoresis General Chapter

This annex is the result of the Q4B process for the Capillary Electrophoresis General Chapter

Eudralex Volume 3 ICH Q4B Annex 11: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Capillary Electrophoresis General Chapter

ICH Q4B Annex 11: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Capillary Electrophoresis General Chapter

The ICH Steering Committee recommends that the official pharmacopoeial texts of Ph.Eur, USP, and JP can be used interchangeable in the ICH regions.

APIC - Quality Agreement Guideline & Template

This document provides guidance for the implementation and maintenance of appropriate Quality Agreements.

Eudralex Volume 10 Annex 1 revised: Clinical Trial Application Form

Please note: Recent changes in the regulatory framework for pharmaceuticals and clinical trials in the EU (mainly consequences of the paediatrics legislation and the legislation on advanced therapies) have required changes to the clinical trials application form. This is the revised version of the clinical trials application form. It will become applicable in the course of the first half of 2010, and is published in advance to allow stakeholders time for preparation. A precise date for applicability is going to be published on this website.

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