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 GMP guidelines are | | | | significant adverse comments this was withdrawn in |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