Direct Links to important GMP API Guidelines

PIC/S Procedure for Handling Rapid Alerts and Recalls Arising from Quality Defects (PI 010-5) July 2017

This procedure covers transmission of information by means of a Rapid Alert between the different parties relating to the recall of medicinal products which have quality defects, including counterfeit or tampered products, when urgent action is required to protect public health and animal health.

FDA Program 7356.002F Active Pharmaceutical Ingredients (APIs)

FDA expects API manufacturers to apply CGMPs to the API process. This Guidance Manual contains specific FDA requirements.

FDA Guidance for Industry: Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients - Questions and Answers

The ICH guidance Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients is intended to provide guidance regarding good manufacturing practice (GMP) for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for managing quality.

APIC - Good manufacturing practices for Active ingredient manufacturers, with EFPIA, 1996

This joint CEFIC/EFPIA Guide describes the principles of GMP compliant manufacture of APIs.

APIC - Quality Management System for Active pharmaceutical Ingredient manufacturers - Integrating GMP into ISO 9001, December 1997

This document gives detailed guidance for API manufacturers for implementing a Quality Management System.

APIC - Manufacture of sterile active pharmaceutical ingredients - guidance 1999

This document provides guidance for the manufacture and handling of sterile APIs.

APIC - Good Manufacturing Practices in Active Pharmaceutical Ingredients Development, 1999

This document provides appropriate GMP requirements during APIs development from non-clinical studies to the submission of the Registration Dossier.

APIC - Guidance on Aspects of Cleaning Validation in Active Pharmaceutical Ingredient Plants

This document is supposed to assist companies in the formulation of cleaning validation programmes

APIC - Computer validation Guide, December 2002

This document provides guidance for the GMP-compliant use of computerised systems for the manufacture of an API or intermediate.

APIC CEFIC Auditing Guide

This document aims to set standards for audits in API production sites and to provide guidance for the implementation and maintenance of an effective audit system.

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