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CAPA – time for a rethink?

CAPA – time for a rethink?

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...
ISO 9001 versus GMP – Part 2

ISO 9001 versus GMP – Part 2

A lot has been said about ISO 9001 in the pharmaceutical industry.  This article tries to compare the two fairly.  You should read Part 1 first to get some idea of the differences.  One of the main problems of comparing GMP and ISO is that the two standards are not...
ISO 9001 versus GMP – Part 1

ISO 9001 versus GMP – Part 1

A lot has been said about ISO 9001 in the pharmaceutical industry.  With pros and cons and comparisons to GMP made all the time.  This will be discussed more in a later article, but as a starter I have listed the clauses of ISO 9001:2015 below.  Those in green text...
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...
Procedure or documented procedure?

Procedure or documented procedure?

In many standards that exist there are often statements such as “there must be a procedure to control training records”.  Whilst I am sure that none of you will disagree with a statement such as this there is an element of unclarity in the statement itself.  It...