Direct Links to important GMP API Guidelines

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

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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.

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APIC - Quality Agreement Guideline & Template

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

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Quality Agreement Template for Generic APIs

This document provides a Quality Agreement Template for Generic APIs.

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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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EU GMP Basic requirements for active substances used as starting materials - EU GMP for APIs

Guidance regarding Good Manufacturing Practice (GMP) for the manufacture of active substances under an appropriate system for managing quality.

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WHO Pharmaceutical products containing hazardous substances

Guideline on the handling of highly active material (drug product and API manufacutre). Focus on HVAC systems, also advice on personal proctective equipment (PPE)

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Auditing Guide - Annex 1 – Pre-Audit Questionnaire

The purpose of this questionnaire is to facilitate the preparation of the auditors for the audit at the API manufacturer's site.

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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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APIC - Supplier Qualification and Management Guideline

This document provides guidance on how to manage suppliers through the complete life cycle of the product.

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GMP Conferences by Topics

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