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WHO-The World Health Organization version
 

The World Health Organization pharmaceutical industry in over one hundred countries worldwide, primarily in the developing world. The GMP (EU-GMP) enforces more compliance requirements than the WHO GMP, as does the Food and Drug Administration's version in the US. Similar GMPs are used in other countries, with Australia, Canada, Japan, Singapore and others having highly developed/sophisticated GMP requirements. In the United Kingdom, the Medicines Act (1968) covers most aspects of GMP in what is commonly referred to as "The Orange Guide", because of the colour of its cover, is officially known as The Rules and Guidance for Pharmaceutical Manufacturers and Distributors.

Since the 1999 GMPs for Active Pharmaceutical Ingredients, by the International Conference on Harmonization (ICH), GMPs now apply in those countries and trade groupings that are signatories to ICH (the EU, Japan and the US), and applies in other countries (e.g., Australia, Canada, Singapore) which adopt ICH guidelines to the manufacture and testing of active raw materials.

GMP is designed to help assure the quality of drug products by ensuring several key attributes, including correctness and legibility of recorded manufacturing and control documentation. Data transfers must be performed in specific ways to avoid mistakes (e.g., writing down a reading on a balance and requiring a second person to also check the balance reading to assure accuracy). Methods have been developed to make this process easier (e.g., links between equipment and central data storage facilities for direct transfer of important data).

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