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