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Posts Tagged MHRA

UPDATE Transitional IMP QP – Important News

UPDATE Transitional IMP QP – Important News

Updated Guest post by Kastur Patel – Transitional IMP QP Many of you reading this will be aware that the new Clinical Trial Regulation No 536/2014 does not allow for transitional QPs. There are 2 types of transitional QPs, those who were ‘grandfathered’ in the 1970’s and

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GMP Deficiencies – MHRA update to top 10

If you were wondering what to add to your internal audit / inspection schedule for the second half of 2012 the MHRA have been very helpful in providing their top ten list of findings from April 2011 to March 2012.  If you look at nothing else this

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Latest QP Question

What are the requirements for unlicensed medicinal products in the UK, do you need QP certification? Where would you find guidance?

Latest QP Scenario Practice

Iron Oxide - used as an excipient in many of your products. You find that the supplier has been irradiating the material without your knowledge. What implication does this have for your product? What does this mean for the effectiveness of your supplier oversight and PQS?


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Alex Hern, Sanofi.


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