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Top 20 posts from this blog

October 31, 2012

Dominic Parry

Here are the 20 most popular posts from this blog.  The most popular is first. Read more

Update to EU GMP Chapter 1 – Pharmaceutical Quality System

October 26, 2012

Dominic Parry

After a longer period of review and many draft versions published the final update to EU GMP Chapter 1 on “Quality Management” comes into operation on 31st January 2013. Here is a summary of the main changes. Read more

Good auditing techniques

October 25, 2012

Dominic Parry

When people talk about good auditing technique it is easy to immediately start covering how to ask questions, how to deal with people and how to make notes.  Whilst this is all true, it is easy to forget that there are 4 stages to the audit process and good auditing technique can be used at all of these stages – as we will see.  This makes for a better audit. Read more

Non-conformity – not following a procedure

October 17, 2012

Dominic Parry

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 standard actually states that you should follow your procedures?  On investigation this is not as easy to find as you might like to think! Read more

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