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Posts Tagged Q8

EMA Guideline on Process Validation – Consultation

  The EMA (CHMP/CVMP) have issued a consultation on an update to their Process Validation Guideline. The consultation is open until 31st October 2012 and can be found here. http://hometeambbq.com/docs/info/ This update incorporates the requirements and philosphies embedded in the ICH guidelines of Q8, Q9 and Q10, moving away

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ICH Q11 – Ready for Implementation

ICH Q11 – Ready for Implementation

  The guidance originally set out in ICH Q8 for Pharmacuetical Drug Development is now available, suitably amended, for Active Pharmaceutical Ingredients in ICH Q11. http://www.cork-screw.org/files/instant credit applicationloan mn On 1st May 2012 the Guideline on Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities) reached

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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?

Testimonials

"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.

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