The EDQM announced on May 17, 2011 the availability of the revised policy document 'Suspension or Withdrawal of a Certificate of Suitability'. The EDQM also annouced information about new CEP suspensions and withdrawals due to failures to comply with the GMP requirements. Read more here.
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.
EDQM requires more Information on the Manufacturer's Localisation (DUNS/GPS) for CEPs
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
Amended Directive 2001/83/EC includes stronger Guidance on GMP for APIs and Excipients
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.
ICH Q11 Draft Gelling On Lifecycle/Change Management and Control Strategy Components
The lifecycle management section of the newest working draft of ICH's Q11 guideline on drug substance development and manufacturing provides allowance for applicants to include change management proposals in their original submissions. Read one here.
Revision or Renewal of CEPs: Requirements for Notifications to the EDQM
The EDQM has to deal with an increasing number of deficiencies in the notifications regarding revisions or renewals of CEPs which makes the procedure inefficient and which could be easiliy avoided. Here you can read more about the most common deficiencies found in the documents submitted to the EDQM.