Direct Links to important GMP API Guidelines

APIC - Guideline for Qualification & Management of Contract Quality Control Laboratories

This document provides guidance for the management of contract laboratories.

Guidelines On The Principles Of Good Distribution Practices of Active Substances For Medicinal Products For Human Use

GDP requirments for the storage and transportation of active pharmaceutical Ingredients

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.

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