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Posts Tagged Quality

The beginning of the end for the UK QP?

How is your Annex 16 implementation going? Let us know by taking our survey: https://is.gd/zs9y64 What does new Annex 16 require of Pharmaceutical companies and Qualified Persons? Is the risk of being a QP in the UK now more than most people want to contemplate? The results

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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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EMA issues new guideline on IMPD for Biologicals

EMA issues new guideline on IMPD for Biologicals

The EMA have published the new guideline on what needs to be included in each section of the Investigational Medicinal Product Dossier (IMPD) [sometimes called the CMC section, stands for Chemistry, Manufacturing and Control; may also be called the CTD for Common Technical Dossier] of the Clinical Trial

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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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EMA – Consultation on quality guideline for Biosimilars

EMA – Consultation on quality guideline for Biosimilars

The EMA has released a revised guideline on the quality requirements for Biosimilars, technology has moved on since the last guideline was issued in 2006 and the industry has a better understanding of the development, manufacturing and quality requirements for biosimilars. All QPs need an understanding 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?

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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Website: http://www.qpquandary.co.uk
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