The quality of any given ‘Special’ is the sum of its extrinsic and intrinsic qualities.
Extrinsic quality derives from the environment within which a ‘Special’ is manufactured. Licensed ‘Specials’ manufacturers are all regulated and inspected by the MHRA but not necessarily to the same quality standards. For example, batch manufactured ‘Specials’ are inspected to more rigorous standards than extemporaneously prepared ‘Specials’. Intrinsic quality derives from the design, specification and subsequent validation and end product testing of a given ‘Special’. Intrinsic quality is not obligatory and is therefore not enforced.
Extemporaneously manufactured ‘Specials’ fall into the category of extrinsic quality only ‘Specials’. Many ‘Specials’ manufacturers supply to this minimum standard simply because they are allowed to do so always provided they follow the ’28 day’ shelf life convention. A serious but little understood consequence of a purely extemporaneous service is that without end product testing, not only is it not possible to verify the quality of the finished product, but it is also more difficult to monitor and therefore adequately manage the competence of the quality systems in operation and their compliance with GMP.
Certificates of conformity or conformance (C of C) are an expression of extrinsic quality only and are of minimal value other than to confirm that a ‘Special’ was manufactured in a licensed facility. Certificates of analysis (C of A) incorporating a statement of GMP compliance provide an enhanced level of assurance because they encompass both extrinsic and intrinsic quality.
Mandeville Medicines is committed to the supply of quality ‘Specials’ and as such, some 95% of its products are supported by certificates of analysis incorporating a GMP compliance statement and this commitment is exemplified by a continued programme of product development and investment, not only in extrinsic quality, but more importantly, in intrinsic quality which is that part of QUALITY that is most likely to have an impact on safety and efficacy.