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Posts tagged ‘Quality Assurance’

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

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

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

The benefits of being IRCA registered

March 27, 2012

Dominic Parry

Our 5-day Pharmaceutical Lead Auditor course is registered with IRCA, the International Register of Certificated Auditors.  This is the world’s premier organisation for professional auditors and sets down minimum standards for auditors and auditor training courses.  Read more

Proposed update to EU GMP Chapter 2 “Personnel”

February 22, 2012

Dominic Parry

This article provides an overview of the current proposed changes to EU GMP Chapter 2 on Personnel.  As with similar blog articles before on Chapters 4, 5 and 8 readers are reminded that the proposed update is still in the DRAFT format (Chapter 2 Draft) and is therefore not yet a requirement of GMP at the time of writing.  Readers should also refer to the actual document for full understanding.

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