what is gmp

what is gmp

5 hours ago 3
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GMP stands for Good Manufacturing Practice. It is a system of regulations and guidelines established by regulatory agencies such as the US Food and Drug Administration (FDA) to ensure that products-like pharmaceuticals, medical devices, food, and cosmetics-are consistently produced and controlled to meet quality standards that guarantee their safety, purity, and effectiveness

. Key aspects of GMP include:

  • Quality management systems overseeing manufacturing processes and personnel training
  • Sanitation, cleanliness, and environmental controls in facilities and equipment
  • Validation and verification of manufacturing processes to ensure consistency and reliability
  • Comprehensive documentation and record-keeping for traceability and accountability
  • Quality control testing of raw materials and finished products
  • Proper packaging and labeling to comply with regulatory requirements
  • Regular inspections and audits to ensure compliance with GMP regulations

GMP regulations are legally enforceable and are designed to minimize risks such as contamination, mix-ups, and errors that cannot be detected by testing the final product alone. The term cGMP ("current Good Manufacturing Practice") emphasizes that manufacturers must use up-to-date technologies and systems to maintain compliance with evolving standards

. Overall, GMP plays a crucial role in protecting public health by ensuring that products are safe, effective, and of high quality throughout their manufacturing lifecycle

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