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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....
Non-conformity – not following a procedure

Non-conformity – not following a procedure

A common finding when auditing is discovering that the organisation or department that you are auditing is not following their own internal procedure or policy.  This is a non-conformity, and should be raised as such.  The problem is – what clause of the...
Dealing with non-conformities

Dealing with non-conformities

When non-conformities are raised during audits a sequence of events needs to follow afterwards in order to deal with the non-conformity correctly.  This post highlights the main process that good auditors should use, as well as highlighting any potential problem...
Errors in procedures

Errors in procedures

The pharmaceutical industry is full of procedures.  This is why GMP is often jokingly re-named to Great Mountains of Paperwork.  Whilst the importance of having good quality procedures in place is vital I often see a focus on getting small problems with procedures...