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Update to the EU’s Good Distribution Practice guidelines

Update to the EU’s Good Distribution Practice guidelines

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...
Auditing abroad

Auditing abroad

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...
Good auditing techniques

Good auditing techniques

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...
Management Review – what is it for?

Management Review – what is it for?

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. Reasons for performing In order to...
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...