GMP NEWS 2008

In October the Center for Biologics Evaluation and Research (CBER) published its annual report for fiscal year 2007 with overviews on the activities of the different CBER competency departments. Get more details here.

On 26 November 2008, the EMEA published a Concept Paper on the Revision of the Guideline on Parametric Release. The revision is carried out in order to take account of the approaches from the ICH Guidelines Q8, Q9 and Q10. Read on here.

On this website, the FDA shows the data of the Annual Fatalities Report after Blood Collection and Transfusion, with detailed data concerning the causes like Transfusion Related Acute Lung Injury (TRALI), Hemolytic Transfusion Reactions (HTR) and Microbial Infection. Read more.

The industry has been waiting for the American Food & Drug Administration (FDA) to publish its revision of the Process Validation Guideline. Now the Agency has made its current thinking regarding process validation public. A summary of the new draft can be found here.

Within the <Note for Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions> the Q4B Expert Working Group of the EMEA published the drafts of the new Annex 4A, 4B and 4C in June. Read on here.

The revision had become necessary in order to adapt the general GMP regulations for active pharmaceutical ingredients (Part II) specifically to the manufacture of herbal medicinal products. Find the details here.

Two new questions and answers have been added to the list of frequently asked GMP related questions. Another Question and Answer has been prepared on active substances whose primary industrial use is not as a pharmaceutical active substance (and the producers of these substances may not be aiming to meet the specific GMP requirements of their pharmaceutical customers). Read more.

The competent committee of the European Parliament (Environment, Public Health and Food Safety) adopted the proposed draft regarding variations to the terms of marketing authorisations for medicinal products with the pertaining amendments on 9 September. Two of the changes are quite interesting.  Find out more.

In order to ensure that the official timelines are met, EDQM has decided to apply the procedure for managing the Certification Scheme more strictly. Find more information here.