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Good Manufacturing Practices (GMP) for Medicinal Products

7 good Manufacturing Practices (GMP) for Medicinal Products Jaya Bir Karmacharya Omnica Laboratories Private Limited Nepal 1. Introduction The term GMP was introduced to regulate Manufacturing and packaging operations in the pharmaceutical company. Until the mid-1960s, operating procedures for the manufacture of drugs consisted of formulae and the basic methods of making Products . Written procedures were often concise and often relied on the individual operator s skill and experience. As batches of medicines increased in number and size, the operating procedures were inadequate to produce consistent and reliable Products . Much attention had focused on the purity of Medicinal substances. Pharmacopoeias and codices specified formulae for mixtures and other preparation, but gave little detailed information on the methods of preparation.

7 Good Manufacturing Practices (GMP) for Medicinal Products Jaya Bir Karmacharya Omnica Laboratories Private Limited Nepal 1. Introduction The term GMP was introduced to regulate ma nufacturing and packaging operations in the

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