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Management Review – who, what, where and when?

Management Review – who, what, where and when?

GMP Management Review meetings The idea of Management Review meetings has only been a formal GMP requirement for the past 5 years or so.  In the many visits that I do to pharmaceutical manufacturing sites I see these done – but rarely done well, which is a real...
Data Integrity – why all the fuss?

Data Integrity – why all the fuss?

Data Integrity has become a ‘hot’ topic The careful and secure control of data and records has become a hot topic at regulatory inspections recently.  One reason for this is the increased use of computer systems to hold data in one form or another.  That...
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 –...
Who should review batch records?  The mistake in GMP

Who should review batch records? The mistake in GMP

It is a requirement of European Union GMP (EU GMP) that batch records are reviewed prior to batch release. But European Union GMP is no longer clear about who should do this, and with recent updates to EU GMP Chapter 2 on Personnel it looks like a big omission has...
Qualified Person – study anytime, anywhere

Qualified Person – study anytime, anywhere

Qualified Person/QP Training courses Our online Qualified Person training is receiving rave reviews. Designed for busy Pharma professionals who find it difficult to be away from the workplace for days at a time. On-line Qualified Person / QP training  Are you thinking...