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Raising non-conformities

Raising non-conformities

by | Jan 12, 2023

Many auditors audit by going into areas, finding things that they don’t like and then announcing their non-conformities at a closing meeting at the end of the audit.  This is somewhat of an old-fashioned way of auditing and whilst it may be the way audits have...
Dealing with problems – for good

Dealing with problems – for good

by | Oct 30, 2022

Problems happen in work and in life.  Problems also happen within any quality system. GMP requires problems to be dealt with correctly: “any deviation  … should be avoided as far as possible.  If a deviation occurs, it should be approved in writing … (EU GMP...
CAPA – time for a rethink?

CAPA – time for a rethink?

by | Oct 16, 2022

All manufacturing sites have a CAPA system, usually a mechanism to deal with things that have gone wrong.  Despite the fact that a lot of focus has been given to CAPA in recent years, there is a great deal of misunderstanding and a clear lack of clarity on what CAPA...
Problems and deviations – avoid blaming the operator

Problems and deviations – avoid blaming the operator

by | Jun 13, 2016

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....