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New EU GMP Directive published

New EU GMP Directive published

New EU GMP Directive published The European Union recently published its new Directive for pharmaceutical manufacturing sites that will replace the existing Directive (Directive 2003/94/EC) for human medicines.  The new EU GMP Directive, Commission Directive (EU)...
Must, Shall and Should – the use of these words in GMP

Must, Shall and Should – the use of these words in GMP

Must, Shall and Should – the use of these words in GMP I am often asked what the difference between these words mean in the context of GMP, so in this post I try and explain, using European Union Good Manufacturing Practice (EU GMP) as my point of reference.  However,...
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...
EU GMP Chapter 9: Self-Inspection – time for an update?

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, EU GMP 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...