PHRM3041 Lecture Notes - Lecture 8: Good Laboratory Practice, Chronic Toxicity
Document Summary
Before a drug or device gets to market: There needs to be a demand for it. A set of standards that form a quality system of management controls for research laboratories and organisations: quality assurance (qa) processes, people, sops, quality control (qc) sampling and testing, codes of practice (gxp) glp/gmp/grp/gcp. First defined set developed in usa in 1979 after widespread discovery of fraudulent research 70s-80s. Rudimentary standards first in nz and denmark then spread to the oecd countries and now global. More firmly established 1987/88 as eu adopts glp directives then 1990 japan. Further extended in 2007 with global co-operation group. To ensure the uniformity, consistency, reliability, reproducibility, quality and integrity of chemical research test results (including pharmaceuticals, medical devices, food additives, food packaging, colour additives and other non-pharmaceutical products or ingredients)
