New ISPE Guide on Process Gases

The ISPE has published a detailed document on the GMP-compliant handling of gases for pharmaceutical and biopharmaceutical production processes. The main focus of this Guide is on the development, the establishment, the implementation and the qualification of process gas systems. Read more here.


GMP non-Compliance causes further CEP Suspensions

The EDQM, the European Directorate for the Quality of Medicines and Healthcare has suspended a number of CEPs following a GMP inspection recently. For more information please click here.


New Version of ISO 19011 on Auditing published

ISO has published an updated edition of the ISO 19011 auditing standard. ISO 19011:2011 provides guidance on the conduct of internal or external management system audits, as well as on the management of audit programmes. You will find more information here.


ICH Q11 close to final Approval

The International Pharmaceutical Quality (IPQ) Journal - one of the most important Journals in the GMP and regulatory environment - reports in a very detailed article, that ICH's "Development and Manufacture of Drug Substances" Q11 Guideline is close to being cleared in Step 4 after some significant changes to the Step 2 draft by the Expert Working Group (EWG). Read more here.


EMA, CVMP - Testing of Mycoplasma Contamination

CVMP published the draft guideline "VICH GL34: Biologicals: testing for the detection of mycoplasma contamination". It is is intended to facilitate the harmonized licensing of new products for veterinary use. More details can be found here.


IPEC publishes GDP Audit Guideline for Pharmaceutical Excipients

The IPEC Good Distribution Practice (GDP) Audit Guideline for Pharmaceutical Excipients has been revised and the new version has been published.  Plese find more information here


Drug Master Files (DMF) - Recorded Webinar with FDA Dr Arthur B. Shaw

On Monday 14 November 2011, the FDA presented a webinar entitled "Introduction to the Drug Master File (DMF)". A recording of this webinar is now available.To see this webinar at no cost please click here


USP elaborates Guidelines to limit Counterfeit Medicines

The USP (the US American Pharmacopeia) plans on implementing regulations which should limit the risks of counterfeit medicines. Read more here.


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