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Monthly archive for February 2012

EU Commission publishes responses to GDP consultations

http://ec.europa.eu/health/human-use/good_distribution_practice/developments/2011_pc_gdp_en.htm Responses to the public consultation on the “Revised Commission guidelines on Good Distribution Practice of Medicinal Products for human use” have been published on the Eudralex website (link above). The feedback has been published as pdf copies with no attempt to collate or summarise.  There are 82 of

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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?


"The knowledge, guidance and advice provided by Alex was excellent. Alex has first hand knowledge of the requirements needed for candidates to be successful QPs and provides a level of training to meet these requirements. I can highly recommend QPQuandry as a service provider"
Alex Hern, Sanofi.


Contact Information

20 Playfield Close, Biggleswade, Bedfordshire, SG18 8JL
Phone: 07813 677741
Website: http://www.qpquandary.co.uk
Email: alex@qpquandary.com"