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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,...
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....
Launch of short on-line GDP course

Launch of short on-line GDP course

We are pleased to announce that following a close partnership with one of our clients we now have available a one-hour on-line course designed to provide people new to the pharmaceutical industry with an appreciation of the main requirements of Good Distribution...
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...