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home > pmps > summer 2003 > good manufacturing practice - an overview
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Pharmaceutical Manufacturing and Packing Sourcer

Good Manufacturing Practice - An Overview

Good manufacturing practice (GMP) is one of those ideas that is widely recognised throughout the pharmaceutical industry, but is not necessarily well understood by everyone whose daily working lives are affected by its principles. This knowledge gap is something that manufacturers need to be aware of since GMP is fundamental to the safe production of pharmaceutical products and, as is often the case, the 'devil is in the detail'. Inspections by the regulatory authorities frequently reveal non-compliances that could easily have been avoided by better training of staff and a greater awareness from managers and supervisors of what is actually required.
History

In the UK, GMP is currently monitored by the Medicines & Healthcare Products Regulatory Agency (MHRA). This new organisation has recently been created following the merger of the Medicines Control Agency (MCA) and the Medical Devices Agency (MDA). The MHRA is an Executive Agency within the Department of Health, and is therefore self-funding through fees for licence submissions and performing inspections.


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By Dominic Parry, Head of Training at Reading Scientific Services Ltd (RSSL Pharma)

Dominic Parry BSc (Hons), CBiol, MIBiol has worked in the pharmaceutical industry for the past 10 years. Initially he worked for Evans Medical, before moving to the quality assurance department of Hoechst Marion Roussel.

Dominic has been principally involved in production, development and quality assurance activities, as well as process improvement projects, auditing and GMP training. He has spent the last four years working for Reading Scientific Services Ltd (RSSL), where he is the Head of Training.

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Dominic Parry
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