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New EU GMP Directive published

The European Union has published its new Directive for pharmaceutical manufacturing sites that is to replace the existing Directive (Directive 2003/94/EC) for human medicines. From having an initial look at the new Directive, here are a few comments.

Update to EU GMP Chapter 8 – Complaints, Quality Defects and Product Recalls

Chapter 8 of European Union Good Manufacturing Practice (EU GMP) has been updated and came into operation on 1st March 2015. This post summarises the main changes.

Update to EU GMP Chapter 6 – Quality Control

A summary of the requirements of the new EU GMP Chapter 6 – Quality Control

Pharma Insights

Read our articles giving interesting insights into the pharmaceutical industry. The 3 most recent articles are shown in the slider and the rest are shown in date order below.

Routes of administration of medicines

A crude way of looking at how we get medicines into the body is this – “if there’s a hole then we’ll put medicines in it and if there is not a hole, then we’ll go and make one”! This article outlines how the intake of medicines is achieved either via absorption or direct injection.

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Clinical trial phases

I am often asked what the main stages of pharmaceutical Clinical Trials are.  In this post I will try and explain.  I should point out that I am not a Clinical Trials expert, but this is my understanding.

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History of the Orange Guide

Pharmaceutical manufacturing sites in the UK will be more than familiar with the “Orange Guide”.  This British publication has for decades contained the requirements of Good Manufacturing Practice.  This article provides a brief overview of the history of this book...

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The Devonport Incident 7th March 1972

Today (7th March 2012) is the 40th anniversary of one of the most infamous pharmaceutical disasters.  Commonly known as the Devonport Incident, this problem concerned the release of non-sterile dextrose infusion bottles onto the market.  It is thought that this...

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What is a medicine?

When I am running GMP training courses I often ask the delegates at the start of the course what a medicine actually is.  This always prompts some interesting discussion and gets people thinking - which is never a bad thing on a training course.  Typical answers...

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We help people in pharma organisations to continually improve their regulatory systems to gain competitive advantage and ensure compliance.

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03 Pharma GMP Lead Auditor

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