Direct Links to important GMP API Guidelines

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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WHO Technical supplements to Model guidance for the storage and transport of time and temperature sensitive pharmaceutical products

Technischer Anhang zur WHO Guideline, mit u.a. Kapiteln zu Design und Wartung von Lagerhäusern, Feurschutz, Qualifizierung von Transportbehältern, etc.

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PIC/S Questions & Answers DISTRIBUTION ACTIVITIES FOR APIs (PS INF 20 2011)

The document is intended to provide guidance to inspectors when inspecting areas relating to two topics: (a) Supply Chain & Distribution and (b) Repackaging & Relabelling operations

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WHO Guidelines on transfer of technology in pharmaceutical manufacturing

This document gives guidance in principle and provides general recommendations on the activities necessary to conduct a successful intra- or intersite tranfer of technology (analytical transfer is also adressed). API and finished dosage forms are covered.

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FDA Guidance for Industry: Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination

This guidance describes the importance of implementing appropriate steps during the manufacturing process to prevent cross-contamination of finished pharmaceuticals and active pharmaceutical ingredients (APIs) with non-penicillin beta-lactam antibiotics.

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Template for the 'written confirmation' for active substances exported to the European Union for medicinal products for human use

Template for the 'written confirmation' for APIs

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GMP Conferences by Topics