GMP NEWS 2011

Through a survey we asked the GMP Newsletter readers whether a change of the European Pharmacopoeia concerning the approval of membrane processes for the production of WFI would be interesting. You can find the results of the survey here.

In Warning Letter evaluation, the topic of process validation/qualification is not frequently observed since it is not an independent item of the cGMP Guide (21 CFR 210/211). In the following, you will find an evaluation of the Warning Letters 2010 on GMP deviations in regard to process validation and qualification in the manufacturing environment. Read more here.

In February, the German Central Authority of the Federal States for Health Protection with regard to Medicinal Products and Medical Devices (ZLG) published its annual report on inspections. Read more here.

The amendmends to the directive 2001/83/EC regarding the prevention of the entry of falsified medicinal products into the legal supply chain were adopted by the EU Parliament on 15 February. These amendments will affect many central fields of drugs manufacturing. As a consequence, the GMP regulations for pharmaceutical APIs and exicpients are going to be tightened. Read more.

The EMA reacts on the fact that the manufacturing of APIs is moving to areas outside the EU, especially to Asia (mainly China and India). Read more here.

On January 26, 2011 the FDA issued the Guidance Agenda: New & Revised Draft Guidances CDER plans on publishing during the calendar year 2011. Click here to read more.

All delegates of the 4th European GMP Conference on 19/20 May 2011 in Heidelberg will receive sample contracts on quality agreements for contract manufacturing, for contract analytics, for... Read more here.

At the beginning at this year, the European Medicines Agency (EMA) published the Work Plan for GMP/GDP (Good Manufacturing Practice/Good Distribution Practice) Inspectors Working Group. This document provides a good overview of the changes upcoming in the GMP/GDP environment - and it might come to a lot of changes. Read more here.

Because of recent investigations on toxicity of Isopropylbenzene (Cumene), there was a need to assign this solvent to the higher Class. Consequently, the ICH Guideline Q3C(R4) had to be revised once more. The final document is now available. You can find out more here.