The manufacturer or assembler of “specials” must hold a Manufacturer’s “Specials” Licence granted by the MHRA. The manufacturing/assembly site and its operations will be inspected for compliance with Good Manufacturing Practice (GMP) and the conditions of the licence. These require that manufacture or assembly is carried out under the supervision of appropriately qualified staff, including a named quality controller and production manager, who are acceptable to the Licensing Authority.
Stockton QC Laboratory can assist units in meeting these standards by providing specialist advice and testing services.