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

EU GMP Annex 1 update: The devil’s in the detail – part 2
12/07/2018

The current annex 1 already lists many of the technologies. The revised annex 1 expands on numerous of these technologies and there are a number of other technologies now included. I won’t say newer technologies; they just weren’t included in the current annex 1. There are technologies I have limited knowledge of which have been expanded/included such as separate sections for Form Fill Seal and Blow Fill Seal, previously covered in just two paragraphs now covering a couple of pages of detail.

Of interest to me from my NIBSC days is the new section on Lyophilisation. During my time working there, I tested many hundreds of freeze-dried vials for sterility, as well as performing environmental monitoring on those facilities. I saw at close quarters the technologies employed to keep the product free from contamination. The guidance offered will hopefully ensure that the process remains free from contamination at particular stages of the process, such as integrity testing of the freeze dryer, validated loading patterns to minimise disruption of air flow and what to ensure, that if seating of stoppers is not complete that they remain in a grade A environment.

Single Use Systems, although not new technology (I was using those over 10 years ago) gets its own dedicated and detailed section. A great deal of the section is dedicated to the measures used to ensure the integrity of these single use systems. Placing importance on making sure that there is no extractable and leachable material in the SUS system is also interesting. Contamination of the product can be chemical as well as biological. There is also a section on closed systems which ties in with similar advice to the other systems I have just mentioned.

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