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Update to the EU’s Good Distribution Practice guidelines

Update to the EU’s Good Distribution Practice guidelines

Good Distribution Practice, or GDP, is the standard used to cover the movement and transport of materials.  Historically GDP covered the movement of finished product from the pharmaceutical manufacturing site to the wholesalers and retailers and strictly speaking this...
Management Review – what is it for?

Management Review – what is it for?

In this post we look at the reasons for performing Management Review, where the idea of Management Review has come from, what should be discussed, what the outcomes should be, who should attend and how often they should take place. This article has been updated in...
Proposed update to EU GMP Chapter 2 “Personnel”

Proposed update to EU GMP Chapter 2 “Personnel”

This article provides an overview of the current proposed changes to EU GMP Chapter 2 on Personnel.  As with similar blog articles before on Chapters 4, 5 and 8 readers are reminded that the proposed update is still in the DRAFT format (Chapter 2 Draft) and is...