EU GMP Annex 1 update: The devil’s in the detail – part 1

Well, it’s almost here. The much anticipated, updated version of EU GMP Annex 1 – Manufacture of Sterile Medicinal Products was published for consultation in December. Over the last few years, Andrew Hopkins of the MHRA and project leader, promised a great deal more detail in the new version, mainly due to a loss of knowledge in recent years caused by experienced staff in the sector retiring. Hopkins is true to his word. The draft annex 1 is a far more detailed document, and arguably easier to navigate. An impressive feat considering the draft is a whopping 50 pages, compared to the current version a mere 16 pages long. I’m not going to mention every change made (bearing in mind this is still in draft some updates may be removed after the consultation period) but I am going to mention details that have caught my eye. Firstly, this is not a rewrite, it is a significant update. Much of the text and guidance from the current version makes it into the update. First up, there is a document map at the start and a glossary of terms at the end. It is an obvious thing to say but it is a lot easier to navigate and find information. Another promise from the many meetings I have attended was the reference to quality risk management (QRM) throughout, once again very much the case. There is a whole page dedicated to Pharmaceutical Quality Systems (PQS) which lists the expectations and goals in relation to the manufacture of sterile products. Moving onto the real detail, I’m not going to give a comprehensive run through of all the additions to Annex 1 but I will try my best to give you a proper taster of the new content. Of course, you can read the draft here for the full picture.

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