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EU Annex 1 Manufacture of Sterile Products Revision 2 – Comparison

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The second revision of the renewed Annex 1 has been published. This second revision boasts a number of smaller and larger changes which we will explore in this post. Overall a greater emphasis has been put on QRM, Contamination Control Strategy (CCS) receives a lot more attention in revision 2 and several small errors have been fixed. We make a side-by-side comparison of revision 1 and revision 2...

Tips & Tricks on Management Review & PQR – Part 1

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The product quality review in the GMP’s are an opportunity for the organization to review the performance annually, but perhaps more important, it provides management an opportunity to understand what the figures mean and the significance of any changes. In short, the PQR in a GMP environment contains; the consolidation of the produced batches and the products introduced to the market, an...

Conducting In-Depth GMP & GDP Audits

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When conducting GMP or GDP audits, you don’t have time to investigate everything in detail, you’ll usually have one or two days for an entire factory, it’s people and its Quality System. Most often you’ll get to glance at a document, a piece of equipment or the types of cleaning agents used in manufacturing. There are, however, times when you will want to investigate something in-depth during GMP...

EU, FDA and WHO Regulations Part Two, FDA Regulatory Requirements and Inspection Tips

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The FDA has always held a special place in our hearts and minds. The “guilty until proven otherwise” approach the FDA is infamous for has become slightly milder over the years, nonetheless we will provide you with some valuable information in this article. It explores why the FDA gained its infamous status and how its inspections are structured, how you can prepare and how the FDA organizes its...