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.
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.
Please click here to download our TSE declaration.
"Specials" manufactured by Moorfields Pharmaceuticals are split into two Categories...
Category "A" Specials
The products supplied in this category have been manufactured to full current 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. All batches have passed the EP Test for Sterility.
Details of these tests are provided for each batch in a Certificate of Analysis which is approved by a qualified person.
These can be downloaded from our "Specials" login area - click here to find out more
Category "B" Specials
Category B products have also been manufactured to full current Good Manufacturing Practice under carefully controlled and monitored conditions, but the product has not been subjected to a sterility test or any analytical work.
Ultimately responsibility lies with the prescribing clinician and they prescribe in the full knowledge that this will be a special. Hence we are only able to provide you with a Certificate of Conformity confirming these details, if requested.
No Certificates of Analysis are availble for Category B "Specials"
