Direct Links to important GMP API Guidelines

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

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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

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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This draft guidance is intended for holders of Type II active pharmaceutical ingredient (API) drug master files (DMFs) that are or will be referenced in an abbreviated new drug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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APIC - Guideline for Qualification & Management of Contract Quality Control Laboratories

This document provides guidance for the management of contract laboratories.

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Guidelines of 19 March 2015 on principles of Good Distribution Practice of active substances for medicinal products for human use (2015/C 95/01)

Good Distribution Practice of active substances for medicinal products for human use

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APIC - Guidance on Handling of Insoluble Matter and Foreign Particles in APIs

This Guidance provides recommendations on GMP-compliant handling of foreign particles in active pharmaceutical ingredients.

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2012/715/EU Commission implementing decision of 22 November 2012 establishing a list of third countries with a regulatory framework applicable to active substances for medicinal products for human use and the respective control and enforcement activities

list of third countries with a regulatory framework applicable to active substances like in the EU

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APIC - eCTD How to do Document

This document provides guidance on how to document API quality in the eCTD.

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APIC - GDP for APIs: "How to do" Document

This document provides guidance on how to implement the requirements of ICH Q7.

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FDA Guidance for Industry: Completeness Assessments for Type II API DMFs under GDUFA

This 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), an amendment to an ANDA, a prior approval supplement (PAS) to an ANDA, or an amendment to a PAS (generic drug submissions).

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