Direct Links to important GMP API Guidelines

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.

APIC - Supplier Qualification and Management Guideline

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

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.

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

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.

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.

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

FDA Guidance for Industry: Heparin for Drug and Medical Device Use: Monitoring Crude Heparin for Quality

This guidance is intended to alert manufacturers of active pharmaceutical ingredients (APIs), pharmaceutical and medical device manufacturers of finished products, repackers, and others to the potential risk of crude heparin contamination

EU/51/2013 Decision on the assessment of a third country’s regulatory framework applicable to active substances of medicinal products for human use and of the respective control and enforcement activities

Commission Implementing Decision of 23 January 2013 on the assessment of a third country’s regulatory framework applicable to active substances of medicinal products for human use and of the respective control and enforcement activities pursuant to Article 111b of Directive 2001/83/EC of the European Parliament and of the Council

FDA Guidance for Industry: Completeness Assessment for Type II API DMFs unter GDUFA

This draft guidance is intended for holders of Type II active pharmaceutical ingredient (API) drug master files (DMFs) that are or will be referenced in an abbreviated new drug application (ANDA) or an amendment or prior approval supplement (PAS) to an ANDA (generic drug submissions)

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