Continuing our blog series into the new draft PIC/S Annex 1 revision, (see part 1 here), part 2 looks at Chapters 3 & 4. As we move into the detailed chapters (chapter 4 and beyond), we will use categorization tables to identify and describe the significance of each change. The categories are: Brand New –…
This is part 1 of a series of blogs which will address the draft annex 1 in full. This series will be presented over the next few weeks, with a focus on individual chapters. For a quick overview and context, you can read our initial blog on the draft here. This first part discusses the draft…
Finally, nearly 3 years after it was announced, the New Annex 1 for Good Manufacturing Practice (GMP) has been released in draft form. The EU and PIC/S Annex 1 has long been the GMP bible for manufacturers of sterile medicines, but with more than 10 years now passed since its previous revision, it is fair…
GMP Annex 1 – sterile manufacture In January PIC/S and the GMP/GDP Inspectors Working Group (on behalf of the EMA) agreed on a concept paper regarding the long awaited update to Annex 1, the primary GMP guidance on sterile manufacturing for Europe and PIC/S member countries. The current version of Annex 1 dates from 2007,…
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