| For any business in the medical and pharmaceutical | | | | a book entitled Rules and Guidance for |
| industry, it is an essential requirement to keep | | | | Pharmaceutical Manufacturers and Distributors 2007 |
| up-to-date with the latest regulations and comply | | | | that is sometimes referred to as the ‘Orange |
| with Good Manufacturing Practice guidelines or GMP | | | | Guide'. This is produced for the benefit of all |
| compliance. GMP compliance is a means through which | | | | pharmaceutical industry operators. |
| all companies in this industry are able to maintain | | | | In many other countries, the International Conference |
| quality whilst proving to be effective in the bigger | | | | on Harmonisation of Technical Requirements for |
| business of saving people's lives through healthcare | | | | Registration of Pharmaceuticals for Human Us (ICH) |
| and quality treatments. | | | | enables them to keep in line with GMP compliance |
| Across the world, different government and official | | | | practices which enable standards to be maintained |
| regulators enforce GMP compliance in different ways, | | | | across the world. Countries such as Australia and |
| but usually this is done using statutes in law. In the | | | | Canada have signed-up to this system of |
| US, the Food and Drug Agency enforces GMP | | | | harmonisation as well as countries from South East |
| compliance as part of its official remit, whilst in the | | | | Asia like Singapore. This is good news for patients |
| UK, the Medicines and Healthcare Products | | | | and end-users of medical device products because it |
| Regulatory Agency (MHRA) acting on the Medicines | | | | means safety and quality healthcare are always at |
| Act of 1968 has legal powers to enforce most | | | | the fore-front of the industry's many priorities. |
| aspects of GMP compliance. The MHRA also publishes | | | | |