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Re: Non PD sort of drugs
All the specifications for all approved drugs are compiled in the USP ( the United States Pharmacopeia), but the enforcement of these are left to the FDA. In Canada, if memory serves well, enforcement is the responsibility of the Food and Drug Directorate (may have changed the name) and each province, but the specs are from both the USP and the BP (British Pharmacopeia). In Europe, most countries have their own pharmacopeia as well as the European pharmacopeia. Michel Bob Anibal wrote: > Before I retired, I was working on a product requiring government > inspection. The inspector also covered a pharmaceutical company. Being a > curious ( some people think weird) person I asked him about the QC on > medicinals. As I remember tolerances were a function of the drug - its > effects and the bodies tolerance of variations. Some drugs where the dosage > is very critical have closer manufacturing tolerances than others. > Bob Anibal > >
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