Nuclear Load of pharmaceutical Products from Japan
Both ECA and Concept Heidelberg increasingly receive requests on whether a pharmaceutical manufacturer has to check substances and medicinal products from Japan for nuclear loads. Read more about the current situation.
EMA's GMDP Inspectors Working Group has agreed on a concept paper on revising chapter 8 'Complaints and Product Recall' of the EC guide. Chapter 8 should introduce Quality Risk Management principles and appropriate root cause analysis work when investigating quality defects/complaints for both marketed products and IMPs. Read on here.
Annual Product Review (APR) as GMP Deviation in FDA Warning Letters
Reviewing FDA's Warning Letters of the last fiscal year reveals that the Annual Product Review (APR) is still a hot topic. The main reasons can be found in failing timely completion and in inadequate processes. Read more.
Results of Survey on EU GMP Guide Revisions of Chapter 5 (Production) and 7 (Contract Manufacture and Analysis)
At the end of last year, drafts about the changes of Chapter 7 (Contract Manufacture and Analysis) and Chapter 5 (Production) of the EU GMP Guide have been published. With regard of these changes, the European Compliance Academy (ECA) conducted a survey. The results were sent to the EMA too and - maybe - influence the final versions. Read more about the results of the survey here
Surveillance of Medicinal Products- Annual Report of the German Federal States
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.
Quality Agreement templates for every Participant of the 4th European GMP-Conference
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.