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