Biomaterial Database

Auditing metabolism studies: a scientist's perspective. 1995

R G Nadeau

Environmental Science Department, Monsanto--Ceregen, St. Louis, MO 63132, USA.

Metabolism studies conducted for submission to regulatory agencies are notorious for presenting difficulties during QA audit. The problems result from many factors, most of which stem from the research nature of such studies. Monsanto-Ceregen's Environmental Science Department (ESD) management has organized a concerted effort to review and change the way our regulatory studies are conducted, especially metabolism studies, with the objective of making the work less expensive in time and money, yet more GLP compliant. The strategy employed toward this objective, which requires that the changes be both developed and implemented by study workers (as opposed to QA workers), is discussed. Examples are given of measures implemented thus far that affect the efficiency and GLP compliance with which our metabolism studies are conducted and audited. These measures fall in two categories: (i) excellent SOPs and (ii) techniques that permit efficient auditing of metabolism study Final Reports.

UI	MeSH Term	Description	Entries
D007221	Industry	Any enterprise centered on the processing, assembly, production, or marketing of a line of products, services, commodities, or merchandise, in a particular field often named after its principal product. Examples include the automobile, fishing, music, publishing, insurance, and textile industries.	Tertiary Sector,Industries,Sector, Tertiary,Sectors, Tertiary,Tertiary Sectors
D007753	Laboratories	Facilities equipped to carry out investigative procedures.	Laboratory
D011786	Quality Control	A system for verifying and maintaining a desired level of quality in a product or process by careful planning, use of proper equipment, continued inspection, and corrective action as required. (Random House Unabridged Dictionary, 2d ed)	Control, Quality,Controls, Quality,Quality Controls
D012015	Reference Standards	A basis of value established for the measure of quantity, weight, extent or quality, e.g. weight standards, standard solutions, methods, techniques, and procedures used in diagnosis and therapy.	Standard Preparations,Standards, Reference,Preparations, Standard,Standardization,Standards,Preparation, Standard,Reference Standard,Standard Preparation,Standard, Reference
D004282	Documentation	Systematic organization, storage, retrieval, and dissemination of specialized information, especially of a scientific or technical nature (From ALA Glossary of Library and Information Science, 1983). It often involves authenticating or validating information.	Documentations
D004341	Drug Evaluation	Any process by which toxicity, metabolism, absorption, elimination, preferred route of administration, safe dosage range, etc., for a drug or group of drugs is determined through clinical assessment in humans or veterinary animals.	Evaluation Studies, Drug,Drug Evaluation Studies,Drug Evaluation Study,Drug Evaluations,Evaluation Study, Drug,Evaluation, Drug,Evaluations, Drug,Studies, Drug Evaluation,Study, Drug Evaluation
D004364	Pharmaceutical Preparations	Drugs intended for human or veterinary use, presented in their finished dosage form. Included here are materials used in the preparation and/or formulation of the finished dosage form.	Drug,Drugs,Pharmaceutical,Pharmaceutical Preparation,Pharmaceutical Product,Pharmaceutic Preparations,Pharmaceutical Products,Pharmaceuticals,Preparations, Pharmaceutical,Preparation, Pharmaceutical,Preparations, Pharmaceutic,Product, Pharmaceutical,Products, Pharmaceutical
D005161	Facility Regulation and Control	Formal voluntary or governmental procedures and standards required of hospitals and health or other facilities to improve operating efficiency, and for the protection of the consumer.	Facility Control,Facility Regulation,Regulation, Facility,Control, Facility,Controls, Facility,Facility Controls,Facility Regulations,Regulations, Facility
D006801	Humans	Members of the species Homo sapiens.	Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D014481	United States	A country in NORTH AMERICA between CANADA and MEXICO.