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 roles of the Heads of Production & QC and the Qualified Person
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 importance of assigning GMP roles and responsibilities
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.
Ensure your team understand the importance of Data Integrity
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...
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.
What Pharma Companies Need to Know about Measuring Instrument Calibration
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.
Must, Shall and Should – the use of these words in GMP
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.
Management Review – who, what, where and when?
The idea of Management Review meetings has only been a formal GMP requirement for the past 5 years or so. In the many visits that I do to pharmaceutical manufacturing sites I see these done – but rarely done well, which is a real shame. So what are these GMP Management Review meetings, why do we have them, what should be discussed, who should attend and how often should we have them?
Standards to use when auditing suppliers
If you are working to Good Manufacturing Practice (GMP) then you will need to audit many of your suppliers. GMP does not really tell you what pharmaceutical supplier standards you should or could use when auditing your suppliers this post lists of all the key standards to use when auditing suppliers including links to all of the key documents and authorities.
EU GMP Chapter 9: Self-Inspection – time for an update?
In the past few years eight of the nine chapters of EU GMP have been updated. However, Chapter 9 has not been updated at all. This is strange as GMP’s stance on Quality Management System thinking has evolved a lot of the past few years, so surely the requirements for the number one mechanism that you have to evaluate this system should be updated too? Here are my thoughts
Data Integrity – why all the fuss?
The careful and secure control of data and records has become a hot topic at regulatory inspections recently. One reason for this is the increased use of computer systems to hold data in one form or another. Let me give you an example of how keeping data accessible can become problematic with a non-pharmaceutical example from my own childhood.
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2020
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