Good Distribution Practice (GDP) Guidelines and Good Manufacturing Practice (GMP) Guidelines require organisations to implement effective Corrective Action and Preventive Action (CAPA) systems. Please read more here
One of the most discussed GMP topics in drug manufacturing is documentation. This article explains how several aspects of documentation are to be handled and discusses new PIC/S specifications. Please read more here
When Novartis's valsartan drug patent approached its end, a market worth several billions of US Dollars was to open its doors. Therefore other manufacturers of generic active pharmaceutical ingredients (API) were racing to develop their own synthesis processes of the substance - which may be an explanation for the contamination. Please read more here
The revision of the EU GMP Annex 1 for the manufacture of sterile medicinal products and its consequences for the pharma production and technology is currently among the most discussed topics in industry. This topic also determined discussions of the more than 60 speakers from the pharmaceutical industry and from authorities and the 1.000 participants who convened at this year's Pharma Congress end of April in Düsseldorf again to discuss the latest GMP/FDA trends. Please read more here
Last December the European Commission published the draft version of the update of the EU GMP Annex 1. This draft, which is roughly three times longer than the current version, was open for comments until end of March. At the Annex 1 Conference end of May 15 speakers and 200 participants subjected the draft a thorough analysis. Please read more here
In 2011, FDA revised their process validation guidelines to transform validation into a lifecycle process as apposed to an activity. This approach is consistent with EU GMP Annex 15. It is therefore desirable to use a similar model for analytical procedures. Please read more here
In early June delegates and speakers from FDA, EDQM, USP as well as from industry concentrated on the latest developments with regard to glass packaging - at a conference jointly organised by the USP, Ph.Eur. and the ECA. Please read more here
Because cleaning and control are critical in the manufacture of (bio) pharmaceuticals and medical devices, a formal microbiological risk analysis (MRA) should provide scientific justification for why and how often a particular disinfectant was used and for how often and in which change further (sporicidal) agents may have been used. The second part of this article discusses the lifecycle approach for confirming the disinfectant rotation programme. Please read more here
In December, the GMP Update webinar summarized the latest developments and changes in the GMP area. In part II of the article you will find out more about the changes in some of the Annexes of the EU-GMP Guidelines as well about the latest news and related challenges with regard to the MRA agreement and what is going on around ICH Q12 and Q3D. Please read more here
