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Food and Drug Administration (FDA)

The FDA is one of the America's oldest consumer protection agencies. It reviews the result of laboratory, animal and human clinical testing undertaken by companies to determine if the product they want to put on the market is safe and effective. To ensure the safety of marketed products, the FDA inspect domestic and foreign manufacturers, check shipments of imported products and collect and test samples for signs of contamination.

Medicines and Healthcare products Regulatory Agency (MHRA) [formerly the MCA]

The primary objective of the MHRA is to safeguard public health by ensuring that all medicines on the UK market meet appropriate standards of safety, quality and efficacy. Safety aspects cover potential or actual harmful effects; quality relates to development and manufacture; and efficacy is a measure of the beneficial effect of the medicine on patients.

Good Automated Manufacturing Practice (GAMP)

The GAMP Forum exists to promote the understanding of the regulation and use of automated systems within healthcare industries. GAMP was founded in 1991 by a core of pharmaceutical experts in the UK who were interested in meeting evolving FDA expectations for GMP compliance of manufacturing and related systems. In 1994, GAMP partnered with ISPE to publish the first GAMP guidelines. GAMP is the acknowledged expert body for computer system validation issues. GAMP 4 was released in 2002.

International Society for Pharmaceutical Engineering (ISPE)

The ISPE is a global, not-for-profit membership organisation that provides education, training and technical publications to life science professionals. The Society was founded in 1980 to improve efficiency and best practice in the pharmaceutical industry.

British Computer Society (BCS)

The BCS is the industry body for IT professionals, and a Chartered Engineering Institution for Information Technology. With members in over 100 countries around the world, the BCS is the leading professional and learned Society in the field of computers and information systems.

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