subject: Gmp Synthesis [print this page] Good Manufacturing Practice (GMP) is a term for the control, management of manufacturing and quality control applied to pharmaceutical substances intended to be used in Human clinical trials. GMP guidelines are continually evolving and the prefix c (meaning current) in cGMP is occasionally used but inferred in the acronym GMP. GMP guidelines affect the aspects of production that would affect the quality of a product. For example the manufacturing process is clearly defined and controlled, operators are trained, records are made, retained and are traceable. In addition, systems are in place that includes recall for a non conforming product.
The phrase 'GMP Manufacture' is typically used for Phase 3 clinical trial production and beyond. 'GMP Synthesis' is an alternative label that is frequently used for the smaller scale production for Pre-Clinical and clinical phases 1 and 2.
In July 2008 the US Food and Drug Administration (FDA) announced that it was exempting Phase 1 drugs for the requirements of GMP after preparing the market in 2006. However, after receiving significant adverse comments this was withdrawn in February 2009.
In the UK, companies can become certified to manufacture new drug substances and offer GMP synthesis, by the UK Medicines and Healthcare Products Regulatory Agency (MHRA). Certification is evidence that the company has the necessary expertise and systems to offer GMP synthesis.
Specialist suppliers to the pharmaceutical industry who offer GMP synthesis also offer process development and other chemical services as GMP synthesis doesn't just happen in isolation but is part of a programme. Keeping up with the FDA and other national authorities is an important part of offering the best service and meeting the needs of the customer, the patient.
