The U.S. Food and Drug Administration regulates the manufacture of pharmaceuticals, foods, medical devices and laboratory protocols according to a set of rules called Good Manufacturing Practices (GMP). GMP regulations are extensive and complex, and most laboratories and manufacturers employ specialists trained in GMP compliance to handle the associated record-keeping and reporting. GMP training programs are available from a number of for-profit, non-profit and free sources, offered as self-paced correspondence courses, web-based training, and on-site seminars and workshops.
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Private Sources of GMP Training
GMP training is offered by a variety of private, for-profit businesses. Most offer a choice of on-site seminars, computer or web-based training programs, so that clients can choose the delivery method best for them. GMP training varies in duration, from weeklong conferences to self-paced training generally broken down into hour-long segments. GMP training programs vary, depending upon the depth of knowledge clients require, but should include a history of GMP legislation, regulations, detailed modules on pharmaceutical, food, or medical topics, and certificates of completion. GMP training programs should be formally accredited.
International Society for Pharmaceutical Engineering
The International Society for Pharmaceutical Engineering (ISPE) is a non-profit organisation offering a variety of online GMP training courses. Curriculum includes U.S. FDA GMP inspection approaches for various systems, including: quality, facilities and equipment, materials and production, laboratory control, and packaging and labelling. ISPE also provides books, manuals, guidance materials, knowledge briefs and regulations handbooks, articles and links to additional training programs.
World Health Organization Basic GMP Training
The World Health Organization (WHO) offers free basic GMP training delivered as downloadable powerpoint presentations. WHO programs include two modules divided into topics covering quality management, sanitation, handling complaints, contracts and analysis, personnel, premises, equipment and materials, documentation, quality control, sterile production, pharmaceutical ingredients and inspections. WHO programs provide a bibliography, trainer's notes, suggested further reading and additional free modules on validation, water and air handling systems. Printed matter can be ordered for a fee.
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