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Posts tagged ‘Audit’

Update to the EU’s Good Distrubution Practice guidelines

March 13, 2013

Dominic Parry

Good Distribution Practice, or GDP, is the standard used to cover the movement and transport of materials.  Historically GDP covered the movement of finished product from the pharmaceutical manufacturing site to the wholesalers and retailers and strictly speaking this is still the case.  However with ever more complicated movements of starting materials, intermediate products and finished products then the principles of GDP can apply throughout the whole supply chain – covering the movement of all materials both to and from a pharmaceutical manufacturing site.GDP Read more

Auditing abroad

November 30, 2012

Dominic Parry

If you perform supplier audits then there are a few things that you should consider.  Firstly, ensure you received good training in how to audit.  This will make for a better audit and will help to ensure you represent your company professionally.  Secondly, try and shadow an existing auditor for a few audits first in order to get a feel for the audit process.  As your experience grows then you should get more confident.  Eventually though you may end up with a new challenge for all new auditors – being asked to perform an audit in a foreign country, where you don’t speak the local language!  How should this be tackled?Auditing foreign language 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

Management Review – what is it for?

September 10, 2012

Dominic Parry

In this post we look at the reasons for performing Management Review, where the idea of Management Review has come from, what should be discussed, what the outcomes should be, who should attend and how often they should take place.  Read more

Dealing with non-conformities

September 4, 2012

Dominic Parry

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 areas. Read more

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