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
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.
The International Committee for Harmonisation (ICH) has published a concept paper on 17 October 2012. According to the announcement the ICH Implementation Working Group (Q7 IWG) is currently working on a Q7 Question and Answer document. Go here to read more.
The Pharmaceutical Inspection Convention/Cooperation Scheme (PIC/S) has published a press release about the PIC/S’s meetings held in Ukraine from 30 September to 5 October 2012. What's new in the PIC/S?
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.
For membership in the Committee for Advanced Therapy Medicinal Products (CAT), the European Commisiion published a public call for interested representatives of patients' associates and clinicians. Read more here.