A new document created by a PIC/S team of APIs experts raises the central issue related to the production and distribution of APIs and provides essential answers and clarification on the topic. Read more about the interesting collection of Questions and Answers here.
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.
EDQM has published an enquiry on the draft concerning a new general chapter 2.9.47 - Demonstrating Uniformity of Dosage Units using Large Sample Sizes and an article on the topic on behalf of the PAT Working Group of the European Pharmacopeia. Read more here.
From 15 April, the European Directorate for the Quality of Medicines and Health Care (EDQM) requires for applications or revisions of a Certification of Suitability (CEP) the indication of the manufacturing site localisation with GPS data or a DUNS number. This change is in line with the requirements laid down in the new EU Site Master File. Read more here
Regarding the developments in research and sciences of TSE and the current data about BSE arround the world, the European Commission revised the "Note for guidance on minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products". Read more here.
The use of validated analytical test methods in GMP regulated laboratories is obligatory. Nevertheless, under certain circumstances exceptions may be allowed. Here you can read FDA's answer to the question asked in the title of this news.
The EMA has published a checklist which is supposed to help applicants to check the correctness and completeness of type IA variation notifications. This will be certainly a precious help for those who have to compile documents under time pressure. Read more here.
EMA and FDA are launching a three-year pilot program that will allow parallel evaluation of relevant quality data components, known as Quality by Design (QbD), of selected applications that are submitted to both agencies at the same time. Read more.
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.
In March 2011, the Food and Drug Administration (FDA) published a new draft guideline which extends the requirements on the separation of penicillin also on other beta lactam antibiotics. Read more here.