EU GMP Annex 1 update: The devil’s in the detail – part 2

By Andrew Ramage

Writing a blog to cover the updates made to EU GMP Annex 1 – Manufacture of Sterile Medicinal Products was quite a challenge due to the sheer amount of new content. Previously I covered changes and updates to the control of personnel, premises and water systems. Now for the rest…

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

By Andrew Ramage

 

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...

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