GMP NEWS 2012

What are the risks of humidity excursions during transportation of products (medicinal products, APIs, intermediates)? A current publication in the USP Pharmacopeial Forum has examined the question. Read more here about the USP article.

The EU Commission has announced on 22 November 2012 that Switzerland has been listed as the first country with equivalent standards in the manufacture of active pharmaceutical ingedients (APIs) to those of the EU. Click here to read more

The introduction of the USP chapters in metallic impurities originally planned for 1st December 2012 has been postponed. Read more here about USP's reasons for that decision.

The European Medicines Agency EMA has published a draft concept paper on the revision of Annex 17 (Parametric Release). Read more.

An ECA Working Group has developed a Version 1 of a Good Practice Guide on Validation. This document is intended to provide support to both regulators and industry. Go here to read more.

On November 1st, 2012, the MycoTOOL® PCR Mycoplasma Detection Kit-based test from Roche Applied Science was approved by the U.S. Food and Drug Administration (FDA) for release testing of a  Roche biopharmaceutical product. More details here.

A international team of researchers, with it’s core at the University of Gothenburg, Sweden, has prepared a guide to assist the scientific community in the quality control process. Find out more.

The Vice-Chair of the USP General Chapters – Microbiology Expert Committee, Tony Cundell, recently provided an update to the chapter’s revision process and what we should see when the draft is published in a future issue of the Pharmacopeial Forum. Read more.

To optimise the efficiency of EMA and the Committee for Advanced Therapies' in the field of ATMP, EMA has streamlined the activities of the CAT. More details here.