Direct Links to important GMP API Guidelines

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.

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

2013/196/EU Commission Implementing Decision of 24 April 2013 amending Implementing Decision 2012/715/EU establishing a list of third countries with a regulatory framework applicable to active substances for medicinal products for human use and the respec

Amendments to list of third countries with a regulatory framework applicable to active substances for medicinal products

2013/262/EU Commission Implementing Decision of 24 April 2013 amending Implementing Decision 2012/715/EU establishing a list of third countries with a regulatory framework applicable to active substances for medicinal products for human use and the respec

Amendments to list of third countries with a regulatory framework applicable to active substances for medicinal products

2013/301/EU Commission Implementing Decision of 24 April 2013 amending Implementing Decision 2012/715/EU establishing a list of third countries with a regulatory framework applicable to active substances for medicinal products for human use and the respec

Amendments to list of third countries with a regulatory framework applicable to active substances for medicinal products

2015/1057/EU Commission Implementing Decision of 24 April 2013 amending Implementing Decision 2012/715/EU establishing a list of third countries with a regulatory framework applicable to active substances for medicinal products for human use and the respe

Amendments to list of third countries with a regulatory framework applicable to active substances for medicinal products

APIC - eCTD How to do Document

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

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

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

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).

Eudralex Volume 3 Quality Working Party questions and answers on API mix

This document provides information on how mixtures of active pharmaceutical ingredient and excipients (API mix) are considered in a marketing authorisation procedure.

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Direct Links to important GMP API Guidelines

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

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

2013/196/EU Commission Implementing Decision of 24 April 2013 amending Implementing Decision 2012/715/EU establishing a list of third countries with a regulatory framework applicable to active substances for medicinal products for human use and the respec

2013/262/EU Commission Implementing Decision of 24 April 2013 amending Implementing Decision 2012/715/EU establishing a list of third countries with a regulatory framework applicable to active substances for medicinal products for human use and the respec

2013/301/EU Commission Implementing Decision of 24 April 2013 amending Implementing Decision 2012/715/EU establishing a list of third countries with a regulatory framework applicable to active substances for medicinal products for human use and the respec

2015/1057/EU Commission Implementing Decision of 24 April 2013 amending Implementing Decision 2012/715/EU establishing a list of third countries with a regulatory framework applicable to active substances for medicinal products for human use and the respe

APIC - eCTD How to do Document

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

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

Eudralex Volume 3 Quality Working Party questions and answers on API mix

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