GMP – Good Manufacturing Practice
Good Manufacturing Practice (GMP) is a fundamental concept ensuring consistent production and control of products according to quality standards, aimed at minimizing risks in the production process. GMP encompasses all aspects of production, from initial materials to premises, equipment, and staff hygiene. Detailed written procedures are crucial for each process affecting the final product’s quality. Systems must be in place to provide documented proof that correct procedures are consistently followed throughout the manufacturing process, ensuring regulatory compliance and demonstrating a commitment to producing safe, quality products.
GLP – Good Laboratory Practice
In the realm of experimental (non-clinical) research, Good Laboratory Practice (GLP) establishes a quality management system for research laboratories and organizations, ensuring uniformity, consistency, reliability, reproducibility, and integrity of non-clinical safety tests. GLP applies to studies assessing the safety or efficacy of chemicals, including pharmaceuticals, on humans, animals, and the environment. It is a data quality system, distinct from laboratory safety standards, focusing on safety, consistency, high quality, and reliability in non-clinical and laboratory testing processes. GLP extends beyond chemicals to include medical devices, food additives, packaging, color additives, and other non-pharmaceutical products or ingredients.