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GLP & GMP .

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GLP and GMP

GLP
GLP is a shortening for Good Laboratory Practice, which is the term for a quality system with regulations that applies to all non-clinical studies conducted for the assessment of the safety of chemicals to man, animals and the environment. The regulations concern the manner in which the studies are planned, performed, monitored, recorded, reported and archived.

GMP
GMP refers to Good Manufacturing Practice, which is a set of guidelines and regulations regarding the manufacturing of drug substances, medicinal products and foods. Among other things, GMP regulates the conditions around the manufacturing, the storage, and the distribution. An important part of the regulations consists of the demand for traceability regarding the documentation of the manufacturing process.

 

 

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