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Quality

All Moorfields Pharmaceuticals products are manufactured in accordance with our MHRA licences and the Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2007, the Orange Guide.

The "Specials" Products are also controlled by the MHRA Guidance note 14, and then end with the Supply of Unlicensed Medicinal Products for Individual Patients.

Product Quality Certificates

Moorfields Pharmaceuticals Product Quality - Category "A" Specials

All Moorfields Pharmaceuticals items are manufactured as "Specials" in accordance with our Manufacturing Licence number MS 11412 or supplied in accordance with our Wholesale Dealer's Licence number WL 11412.

No application for a product Licence has been made for the products supplied. Full efficacy and toxicity tests have not been carried out and the products have not been assessed by the MHRA.

The products supplied have been manufactured to full Good Manufacturing practice and a representative sample of each batch is fully analysed and tested according to validated and documented procedures. They meet all compendial standards, where such standards exist, and our own in-house specifications where no such standard exists. Details of these tests are provided, if required by a member of the Medicines Inspectorate.

All batches have passed the EP Test for Sterility.

Moorfields Pharmaceuticals Product Quality - Category "B" Specials

No application for a product Licence has been made for the products supplied. Full efficacy and toxicity tests have not been carried out and the products have not been assessed by the MHRA

The products supplied have been manufactured to full Good Manufacturing Practice under carefully controlled and monitored conditions, but the product has not been subjected to a sterility test or any analytical work.