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Monthly archive for March 2012

FDA warns against phthalate use in medicines

FDA warns against phthalate use in medicines

See the article in InPharm magazine  http://www.inpharm.com/news/171935/fda-warns-against-phthalate-use-medicines and join in the new Twitter hashtag. Questions like this are being set @QPQuandary: Phtalates in medicines.  #QPQuandary – what are Phtalates and where would you find them in medicinal products? tweet back and use hashtag in your answers 🙂 Follow @QPQuandary for

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Differences in UK and Canada – recalls for product mix up

The most recent MHRA drug alert is a Class 1 recall (action within 24 hours) regarding one batch of Co-codamol 8/500 tablets which may contain rogue higher-strength Co-codamol 30/500 tablets.   http://www.mhra.gov.uk/Publications/Safetywarnings/DrugAlerts/CON146826   Pharmacists have been requested to contact patients and request return of any unused product.  All

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FDA takes action on shortage of medicines

  There has always been a requirement for Pharma companies to inform regulators when there is going to be a shortage of any medicine, particulalry when they are life-saving products, after all patient safety must be protected.  But recently the number of products being added to the

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FDA publishes draft guide on qualification of Heparin suppliers

quick cash direct lenders   http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291390.pdf   The FDA have asked for comments on this draft guidance within 60 days.  The document sets out five key recommendations, none of which will surprise those of us working in the EU.   Indeed, some may question why a guideline

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European Medicines Agency releases good pharmacovigilance practice modules for public consultation

finding one hour payday loan lendersfast cash americaloan people bad credit Released on 22nd Feb 2012 the first seven modules (confusingly I, II, V, VI, VII, VIII & IX) are out for consultation.  Follow the link above to find the draft GVP modules and the forms for

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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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