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.
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.
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Eudralex = The rules governing medicinal products in the European Union
Volume 4 – GMP Human & Veterinary – represents THE European GMP for medicinal products.
The annexes apply, as appropriate, equally to Part I and Part II (not only to Part I). Part II is part of the GMP (and not outside/beside the GMP).
Part III contents a collection of supporting (not binding) documents but recognized by regulators as an acceptable way of thinking, in particular to Quality Risk Management (Q9) and to Pharmaceutical Quality Management System (Q10).
Hi – not sure about this, i.e the annexes are applicable to API GMP. Will check out and get back to you. Dominic
Hi Yves,
Thanks for you comments. I have checked this out and updated the blog. Regards, Dominic
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.
Hi Dominic,
I appreciate your open-mind.
My “knowledge” about this particular topic relies on discussions I had with regulators early 2006 (just after the move from Annex 18 to Part II).
As we can observe, this point is still causing troubles by API manufacturers and especially for the auditors in charge of API. Many companies are still refusing to apply as appropriate the annexes to their manufacturing processes.
Hi Yves, I thought this might happen. I am not sure that this is fully understood. Dominic
Thanks, I’ve seen your blog before during my, all of the ex-pats are linked together, which is really cool. Thanks for the mention and I put your link up here too.