GMP News and Articles
Read our articles on pharmaceutical GMP regulatory developments as well as news about our pharmaceutical training courses. The 5 most recent GMP news articles are shown in the slider and the rest are shown in date order below.
If you have some GMP news you would like us to publish then please contact us.
The MHRA’s GXP data integrity guide was published in March 2018. ‘GXP’ refers to the various good practices regulated by the UK MHRA, including the Good Laboratory Practice Monitoring Authority (GLPMA). These are Good Clinical Practice, Good Distribution Practice,...
This free GMP video lasts less than 2 minutes and you can download it for your personal use OR as a part of any refresher/compliance training programme you are running in your organisation providing you leave the opening and closing credits part of the video.
In this article we explore the controls needed to both approve Pharma suppliers and to control the purchasing of materials from them
We are very pleased to announce that the Royal Society of Chemistry has just approved our suite of online Pharma compliance/refresher training courses
In this video, we look at “The roles of the Heads of Production & QC and the Qualified Person” and what GMP’s requirements are when it comes to roles and responsibilities as well as the specific duties of these three individuals.
The video in this article is part of a unit in our online QMS courses that looks at how to implement a Quality Management System and, in this video, we look at the first principle associated with such implementation – that of adequately assigning roles and responsibilities.
Now Available - online Data Integrity training for your team Our 20-minute online Data Integrity training course will ensure your entire team understand the importance of Data Integrity and their role in meeting the expectations of EU Inspectors (such as the UK’s...
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.
According to pharmaceutical cGMP (current Good Manufacturing Practice) guidelines, pharma companies need to conduct regular instrument calibration as part of their validation and qualification activities. This article gives an overview of what is involved.
What is the difference in meaning between these words in the context of GMP?, In this post I explain, using EU GMP as my point of reference, although as you will find out, there are occasions within EU GMP where the incorrect terms have been used.
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