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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...
Standards to use when auditing suppliers

Standards to use when auditing suppliers

If you are working to Good Manufacturing Practice (GMP) then you will need to audit many of your suppliers.  These could be suppliers of chemicals and packaging components, as well as suppliers of analytical testing or calibration services.  GMP does not really tell...
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...
Problems and deviations – avoid blaming the operator

Problems and deviations – avoid blaming the operator

In the manufacture of any form of product it is inevitable that, from time to time, things will not go to plan.  Problems and deviations from normal practice are a fact of life, and in GMP this is permitted, as long as they are controlled and dealt with correctly....
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 –...
New course on Data Integrity

New course on Data Integrity

This course has already run very successfully on an in-house basis for our clients who are increasingly concerned to ensure that they comply with the latest regulations from the EU and the FDA regarding the data integrity of their systems. On this one day course...