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GLOSSARY

GMP/cGMP (Good Manufacturing Practices)

DEFINITION

Good manufacturing practices, usually shortened to GMP, refers to a series of guidelines that have been put in place to regulate the sale and manufacture of a number of items including medical devices and pharmaceuticals. These practices are instituted by the FDA, and the goal is to ensure drug products are safe, effective, and easily identifiable. GMP regulations are designed to be flexible while also meeting a number of minimum requirements. A lot of drug development companies use unique approaches that surpass standards instituted by the FDA’s GMP requirements. Organizations that follow all GMP regulations typically have lower rates of contamination, errors, and mistakes during the manufacturing process.

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