Resources

GMP

QMS

Raising non-conformities

Raising non-conformities

Many auditors audit by going into areas, finding things that they don’t like and then announcing their non-conformities at a closing meeting at the end of the...

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GDP & RP

Raising non-conformities

Raising non-conformities

Many auditors audit by going into areas, finding things that they don’t like and then announcing their non-conformities at a closing meeting at the end of the...

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Dealing with problems – for good

Dealing with problems – for good

Problems happen in work and in life.  Problems also happen within any quality system. GMP requires problems to be dealt with correctly: “any deviation  … should be...

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RPi Training

RPi Training

RPi Training Following a recent announcement by the MHRA this article highlights the importance of the RPi role after the transition period has finished and the...

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Inspired News

Pharma Insights

Annex 1 2022 Section 1: Scope

Annex 1 2022 Section 1: Scope

In the first article I summarised the background to the latest update to Annex 1. In this article I want to focus on sections 1, “Scope”. The scope of a document...

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QP

ISO 9001 versus GMP – Part 2

ISO 9001 versus GMP – Part 2

A lot has been said about ISO 9001 in the pharmaceutical industry.  This article tries to compare the two fairly.  You should read Part 1 first to get some idea of...

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ISO 9001 versus GMP – Part 1

ISO 9001 versus GMP – Part 1

A lot has been said about ISO 9001 in the pharmaceutical industry.  With pros and cons and comparisons to GMP made all the time.  This will be discussed more in a...

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