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 you what standard you should or could use when auditing your suppliers, so below is a list that may be useful.

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EU GMP Chapter 9: Self-Inspection – time for an update?


In the past few years eight of the nine chapters of EU GMP have been updated. However, Chapter 9 has not been updated at all. This is strange as GMP’s stance on Quality Management System thinking has evolved a lot of the past few years, so surely the requirements for the number one mechanism that you have to evaluate this system should be updated too? Here are my thoughts

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Data Integrity – why the fuss?

Computer Systems Validation

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. Let me give you an example of how keeping data accessible can become problematic with a non-pharmaceutical example from my own childhood.

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