The structure of European Union (EU) GMP has been adjusted slightly as can be seen from the EUDRALEX web-site. A new Part 3 has recently been introduced.  For some time now GMP has been split into 2 Parts.  Part 1 covers conventional GMP for finished pharmaceutical products.  This consists of the 9 Chapters of GMP and 20 or so Annexes.  How these work together can be seen in a separate blog article entitled How GMP Works.

In the early part of the last decade Active Pharmaceutical Ingredients (API) GMP was introduced and was added as Annex 18 of EU GMP.  This was really a mistake as the Annexes add to the 9 Chapters of GMP where necessary.  API GMP (formerly Annex 18) is a stand-alone GMP guide for manufacturers of APIs and was not an Annex in the traditional sense.  As a result API GMP was removed from conventional GMP about 5 years ago and added to a new Part 2, where it now sits next to GMP rather than part of  GMP.  From this point GMP now had 2 parts – Part 1 containing conventional GMP for finished products (the Chapters and Annexes) and Part 2 containing API GMP on its own.

In the last 6 months a new Part 3 has been introduced.  This is entitled “GMP related documents” and includes the following sections.  The sections cover guidelines that support and compliment GMP.  Click on the documents to open.

Site Master File


ICH 10

MRA Batch Certificate

The Site Master File section covers explanatory notes on the preparation of a Site Master File.

The section on Q9 Quality Risk Management means that what was for some time Annex 20 on Risk Management has been moved out of conventional GMP (Part 1) and put into the new Part 3.

The section on Q10 Note for Guidance on Pharmaceutical Quality System means that the long-awaited guidance on pharmaceutical quality systems, which was expected to go into Part 1 as Annex 21, now also sits in Part 3.

The final section on MRA Batch Certificate gives guidance on the acceptance of finished products from one EU country to another.

UPDATE 30th March 2012

A good question has been raised by Yves asking if the Annexes are applicable to Part 2 (API GMP).

The annexes were originally written for finished product GMP (Part 1) and many were written with finished products in mind, such Liquids, Creams and Ointments (Annex 9) and Metered Dose Inhalers (Annex 10).  I have spoken to the UK Regulatory Authority (MHRA) and they have told me that for API GMP (Part 2) you should use the Annexes where relevant and appropriate, such as Annex 15 on Validation and Qualification.

I hope this clarifies.