Yesterday the MHRA released their first two blogs;
Written by Mark Birse, Group Manager for the MHRA Inspectorate, the first blog covers the plan to bring blogs from all areas of GxP, including;
– Compliance management approaches
– Data integrity
– Preventing drug shortages
– Significant findings from our inspections
– Supporting innovation and our work with the MHRA Innovation Office
– Upcoming learning opportunities
Furthermore, and quite helpful, will be details on aspects of their inspectors roles, common inspection deficiencies and how to avoid similar pitfalls. The blog will also promises to keep us updated on upcoming conferences.
The second blog gives detail on “Being an MHRA inspector” and explains how the MHRA protect public health in the UK and Europe.
We are happy to see that the MHRA are now blogging… but will these blogs be useful?
It is certainly interesting for the uninitiated to see how the UK Competent Authority (MHRA) are protecting health, and also to see some of the other high-profile areas that the agency cover, but what do we think they should blog about next?
Personally we believe that the foundations of GDP (Good Distribution Practice) are critical to support compliance. With the change in regulations many sites are failing their responsibilities, as they don’t have the proper training or knowledge to keep abreast of these new regulations.
There are few resources of value, and the plethora of free online GDP training courses offer no real value.
Attend the MHRA Symposia, we hear you say? A number of customers who have had training with us have done exactly that, but found the level of detail too high for someone entering into the arena.
When challenged on this we were advised that an attempt had been made to hold an introduction to GDP/foundations of GDP day… but the same people attended.
How can this work better? Ban all of the experienced RPs and staff, especially those from big pharma, who attend the morning, have lunch, and sneak off early because the company are paying.
A little more about the MHRA;
The MHRA was formed in 2003 when the MCA (Medicines Control Agency) and the MDA (Medical Devices Agency) merged. In 2013 the MHRA merged with the NIBSC (National Institute for Biological Standards and Control) and was re-branded,.
The MHRA are an executive agency of the Department of Health and employs over 900 people. The MHRA are funded by the DoH (Department of Health) for the regulation of medical devices, but medicine regulation is funded by fees from the pharmaceutical industry.
Are you up to speed with the regulations, or are you concerned your next inspection will evidence a lack of compliance?
Contact us for a free, five minute consultation, and we can often help you for nothing!
Welcome to a new paradigm!
10 Mar 2020
2 Apr 2019
2 Apr 2019
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