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Notification to MS licence holders due to compliance concerns

Posted by: , Posted on: - Categories: Compliance matters, Good manufacturing practice

In January 2015, MHRA published guidance to ‘specials’ manufactures, to provide an interpretation of the good manufacturing practice (GMP) requirements for specials manufacturers.

The GMDP Inspectorate have been concerned that some Specials manufacturers have not always been receiving written orders e.g. fax, email, from Pharmacists for supply of a ‘Special’, this mainly appears to apply to non-sterile specials.

MHRA  have consulted with the  General Pharmaceutical Council and the Royal Pharmaceutical Society and they point to the Professional Guidance for the Procurement and Supply of Specials published by the Royal Pharmaceutical Society in December 2015 where, on page 7, the following paragraph can be found:

  1. Pharmacists and their teams agree with the supplier what they require to meet the prescription, this includes strength, formulation and, where relevant, requirements for excipients e.g. sugar-free or alcohol-free formulations, and flavourings. This is based on the pharmacist’s understanding of the clinical needs of the patient. Where necessary the agreed formulation is confirmed to the manufacturer in writing.

The General Pharmaceutical Council and the Royal Pharmaceutical Society take the last sentence as requiring a written form of an order to confirm the formulation of the Special required and the General Pharmaceutical Council issued a clarification on this topic through Regulate on 14 April 2016.

MHRA recognise that MS holders have had difficulties in getting some customers to provide written orders and hope this will clarify the situation and ensure written orders are received for all Specials supplied.

GMDP Inspectors will be assessing the application of this guidance in all future inspections of specials manufacturers to ensure consistency in expectations for placing orders.

I would like to thank Graeme McKilligan and John Clarke, Senior GMDP Inspectors, for authoring this blog that I have posted on their behalf.

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