GMP aspects of Contract Manufacturing
Author: Dr. Maurice Wermeille, Sr. Consultant at PMS Process Management System Ltd. 1. Introduction Contract manufacturing is used in situations when one company, the “contract
May 7, 2018
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New EU GMP Cleaning Validation guidelines for the manufacture of medicinal products in shared facilities
The new version of Annex 15 EU GMP which comes into operation 1st of October 2015 lists significantly updated approach for the Cleaning Validation. The
August 7, 2015
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What is the minimal volume that has to be collected for particle or germs counting in clean rooms grades C and/or D?
Is there any regulation or recommendation for defining the minimal volume that has to be collected depending on the volume of the clean room area?
November 7, 2014
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Comments about the revision of the EU GMP Annex 15
The revision of the Annex 15 “Qualification and Validation” is expected to be approved by EC in October 2014. The revision of this guideline represents
April 21, 2014
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