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Sanam replied to the topic No GMPs in the forum Quality Systems Management 7 years ago
GMP regulations require a quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mixups, and errors. This in turn, protects the consumer from purchasing a product which is not effective or even dangerous. The purpose of these regulations is to assure the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations. GMP Manufactured Products cost more than non-GMP Manufactured Products. The requirements for QA review, process validation, stability studies, and recurring personnel GMP training add to the cost of most GMP manufactured products. Without such GMP , even well-designed drugs and medical devices may become ineffective and unsafe from defects, contamination, mislabeling, and other errors.It is important to have GMP