GMP NEWS 2012

18.01.2012

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.

More New ISPE Guide on Process Gases

12.01.2012

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.

More GMP non-Compliance causes further CEP Suspensions

12.01.2012

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.

More New Version of ISO 19011 on Auditing published

12.01.2012

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.

More ICH Q11 close to final Approval

12.01.2012

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.

More EMA, CVMP - Testing of Mycoplasma Contamination

03.01.2012

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

More IPEC publishes GDP Audit Guideline for Pharmaceutical Excipients

03.01.2012

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

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

03.01.2012