Direct Links to important GMP API Guidelines

FDA Guidance for Industry: Alternate Source of the Active Pharmaceutical Ingredient in Pending ANDAs (Posted 12/12/2000)

This guidance is intended to descibe the Office of Generic Drugs' policy on the use of alternate sources of APIs in unapproved abbreviated ANDAs

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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.

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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.

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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.

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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.

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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

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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.

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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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2014/1252/EU Commission delegated Regulation (EU) No 1252/2014 of 28 May 2014 supplementing Directive 2001/83/EC with regard to principles and guidelines of good manufacturing practice for active substances for medicinal products for human use

GMP for active substances for medicinal

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FDA COMPLIANCE POLICY GUIDE Sec. 490.100 Process Validation Requirements for Drug Products and Active Pharmaceutical Ingredients Subject to Pre-Market Approval

This Compliance Policy Guide explains the enforcement policy on the timing of the completion of certain validation activities for drug manufacturing and API manufacturing.

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