Specials manufacturers
In order for a company to manufacture a Special in the UK they must hold a Manufacturer's Specials (MS) licence issued by the Medicines and Healthcare products Regulatory Agency (MHRA). This licence guarantees that the manufacturer adheres to regulatory standards at all stages of production. This includes the sourcing of ingredients, the development, labelling and packaging of the product and the manufacturing and supply processes.
Under the terms of the licence the manufacturing site and its operations are inspected by the MHRA for compliance with Good Manufacturing Practice (GMP) and the relevant provisions of the Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 2005.4 These require that the manufacturing is carried out under the supervision of appropriately qualified staff, including a named quality controller and production manager.In addition, the inspector will also take account of product specifications, labelling, stability data and expiry dating.
The release of a Special is authorised by the quality controller who must ensure that the product is of the quality required for its intended purpose and that it complies with any relevant pharmacopoeial monograph standards. Written records of the manufacture and supply of a product are kept for five years and must be made available to the MHRA on request.
Products manufactured under an MS licence must state on the label the manufacturer's specials licence number as well as batch number and expiry date.
The MHRA maintains a Register of Licensed Manufacturing Sites which includes manufacturers with an MS licence.