The European Compliance Academy's (ECA) GMP Guideline Manager CD is a very useful tool, providing all relevant guidelines on a single CD. It is distributed to all members of the ECA. This year the CD was issued in its 15th edition. Read more.
Written Confirmations: Time is running out - new EU Progress Report
The EU Commission has published a progress report giving an overview on 20 major countries and their status of preparation for adhering to the new rules. It seems there are still quite a few challenges. Read more.
FDA publishes GMP Requirements for "Combination Products"
As of 22 July 2013, cGMP requirements on combination products will apply in the USA as 21 CFR Part 4. But what are combination products? These are composed of medical products, medicinal products, and ... Read more here.
Sample Documentation on EU Site Master File published
The introduction of the EU Site Master File (Part III of the EU GMP Guide) has significantly changed the requirements on the creation of a company description. The very precise instructions have all disappeared. New requirements have been added. A sample documentation shows how to take into account the new requirements in a SMF. Read more here.
Written Confirmations - How is the EU pharmaceutical Industry dealing with that?
To find out how pharmaceutical companies in the EU are seeing the challenges with the Written Confirmations, the European QP Association conducted a brief survey amongst its members beginning of this year. Almost 300 QPs gave answers to the questions. Read more.
One often wonders which differences do exist between the US American cGMP regulations (21 CFR 211) and the EU GMP Guide - and which parallels they have. What's the place for ISO 9001 in these phama specific regulations? In order to support answering the questions, the ECA developed a Good Practice Guide "GMP Matrix" a few years ago. Now, this matrix has been completely revised. Read more.
The National Institute for Biological Standards and Control (NIBSC), currently part of the Health Protection Agency (HPA), will officially become a new 'centre' of the Medicines and Healthcare products Regulatory Agency (MHRA) alongside the Clinical Practice Research Datalink (CPRD). More details can be found here.