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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...
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...
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...
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...
Auditing closing meeting template

Auditing closing meeting template

  Here is a free template for things that you should include in an auditing closing meeting. Thank the auditees for their time Thank them for allowing you to audit them Remind the auditees of the reason for the audit Remind the auditees of the standard that you...