GDP & RP News and Articles
Read our articles on GDP and Responsible Person (RP) regulatory developments as well as news about our courses in this area. The 5 most recent articles are shown in the slider and the rest are shown below.
New course on Data Integrity
This course has already run very successfully on an in-house basis for our clients who are increasingly concerned to ensure that they comply with the latest regulations from the EU and the FDA regarding the data integrity of their systems.
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MHRA publishes new GMP Data Integrity Guidance
Hot off the press – find out more about new guidance from the MHRA on GMP data integrity expectations for the pharmaceutical industry.
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The main differences between GDP and GMP
The European Union’s guidelines on Good Distribution Practice (GDP) were updated at the end of 2013. This post covers an overview of the main differences between GDP and Good Manufacturing Practice (GMP).
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GDP and GMP training courses
Interactive and thought provoking classroom and online GDP and GMP training courses facilitated and developed by Pharma experts with great training abilities
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GXP / GMP Consultancy
Global projects successfully undertaken for some of the largest Pharma businesses
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Curriculum Vitaes in Training Records
I have been working with two multinational pharmaceutical companies recently and both have Corporate GMP requirements that all personnel have a copy of their Curriculum Vitae (CV), or résumé (if you are on the other side of the Atlantic), in individual’s training records. This at first seems a reasonable and simple requirement to implement – but I have seen a number of problems and a solution that may be of interest.
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Update to the EU’s Good Distribution Practice guidelines
The European Union’s GDP guidelines were updated on the 7th March 2013. This article is a simplified overview of the new GDP guidelines and features an opportunity to download a copy of the full Guide.
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Non-conformity – not following a procedure
A common finding when auditing is discovering that the organisation or department that you are auditing is not following their own internal procedure or policy. This is a non-conformity, and should be raised as such. The problem is – what clause of the standard actually states that you should follow your procedures? On investigation this is not as easy to find as you might like to think!
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Pharma compliance training
Use Inspired Pharma to deliver your next Pharma compliance training programme deploying either our effective online learning courses, our GMP experts or use both for maximum impact
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Procedure or documented procedure?
In many standards that exist there are often statements such as “there must be a procedure to control training records”. Whilst I am sure that none of you will disagree with a statement such as this there is an element of unclarity in the statement itself. It surrounds the use of the word “procedure” and what is meant by a procedure.
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November
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January 2019
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