GMP NEWS 2013

The European Commission has published the draft of the new EU-GMP Guideline Annex 16 "Certification by a Qualified Person and Batch Release". Read more about the envisaged changes.

On June 25, 2013 the US FDA published a new Good Manufacturing Practice Guide for Cosmetic Products. Please read more here.

The level of cooperation between inspectors and assessors when handling "QbD" applications involving RTRT (Real Time Release Testing) was added to the Q&A part of the EMA's website in June 2013. More information can be found in the News.

The two guidelines on procedures and categories of variations have been recently combined in an updated document. More details about the "Variations Guideline" recently published on the Commission Website can be found here.

On the FDA website, you can find the slides of a presentation made by Robert Sklamberg, Director of CDER's Office of Compliance in May 2013. The topic deals with the challenges presented by globalisation of manufacturing and distributing. Read more here.

The EMA Guideline on the European Drug Master File (ASMF) Procedure was updated again. Learn more about the new requirements API manufacturers and applicants will be facing.

The questions "For an aseptically produced product, where should bioburden monitoring take place?" and "What is the maximum accepted bioburden level?" are answered by EMA on its questions and answers page. Read more.

Medicines regulator implements innovative software to analyse risk data and target inspection activity. Read more.

The USP has deferred the date for the publication (1st May 2013) of the revised section 5.30.60 in the "General Notices" until further notice. This section would link the General Chapters on Metallic Impurities <232> and <233> to drug product monographs. Read more here about USP's reasons for that decision.