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Key GMP personnel and their duties

Key GMP personnel and their duties

Some of the most popular articles on our blog are the four we published some four years ago about  key GMP personnel and their duties. These can be found through these links: Part 1 – Production, QC and QP personnel Part 2 – QA personnel Part 3 –...
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. Reasons for performing In order to...
The benefits of being IRCA registered

The benefits of being IRCA registered

Our 5-day Pharmaceutical Lead Auditor course is registered with IRCA, the International Register of Certificated Auditors.  This is the world’s premier organisation for professional auditors and sets down minimum standards for auditors and auditor training...