Amendment to Chapter 5 of the GMP Guide ("Qualification of Suppliers") Expected in Early 2008

GMP News
16 January 2008
 

Amendment to Chapter 5 of the GMP Guide
("Qualification of Suppliers") Expected in Early 2008

 
On 18 December 2007 the European Medicines Agency (EMEA) has published its work plan for the GMP/GDP Inspectors Working Group for the year 2008. This document summarises the planned activities of the respective working group and gives a comprehensive overview of what the pharmaceutical industry can expect in the following months. One of the recent developments will focus on Qualification of Suppliers:

Chapter 5 of the GMP Guide will be amended in order to reflect the new obligations of manufacturing authorisation holders to only use active substances that have been manufactured in accordance with GMP. Also, a common approach will be finalised on what is expected from manufacturing authorisation holders with respect to the assurance of the quality of raw materials used.

The text for public consultation is expected in early 2008.

Besides Chapter 5, also chapter 3, 4 and 5 and the annexes 2, 6, 13 and 14 are under revision.

You can find the whole work plan here:
http://www.emea.europa.eu/Inspections/docs/gmpgdpworkplan.pdf
 

Learn all relevant aspects to implement and/ or improve a professional Supplier Qualification System which fulfils regulatory GMP requirements during the ECA Course

Learn more about inspections and audits in the following ECA course:


Author:
Wolfgang Schmitt
On behalf of the European Compliance Academy (ECA)
 

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