Compliance with Current Good Manufacturing Practices Regulations and Selected Characteristics of Drug Manufacturers

摘要

The paper explores the relationship between compliance with Current Good Manufacturing Practices (CGMPs) and selected characteristics of drug manufacturers. The study is based on CGMP inspections conducted by the Food and Drug Administration during the period FY 1978--FY 1982. The characteristics explored include: dosage form of drugs manufactured; establishment size; number of products manufactured; the inspection and sampling history of the establishment; and corporate affiliation.