Highlighting key issues and differences among GMPs of Europe, Canada, and the WHO, this reference examines US law and governmental policy affecting domestic and multinational pharmaceutical manufacturing. The book recommend pragmatic ways to interpret and comply with FDA CGMP regulation and related criteria. They focus on geographical redistribution of manufacturing facilities, accommodation of a diversity of regulatory and statutory governance, adaptation to disparate human resources, and new growth areas of manufacture and distribution of homeopathic remedies and dietary supplements, in addition to the greater quality control required of pharmacists and other authorized dispensers.

Status and Applicability of U.S. Regulations: Current Good Manufacturing Practices in Manufacturing, Processing, Packaging, and Holdings of Drugs. Finished Pharmaceuticals: General Provisions (Subpart A). Organization and Personnel: (Subpart B). Buildings and Facilities: (Subpart C). Equipment: (Subpart D). Control of Components and Drug Product Containers and Closures (Subpart E). Production and Process Controls (Subpart F). Packaging and Labeling Controls (Subpart G). Holding and Distribution: (Subpart H). Laboratory Controls (Subpart I). Records and Reports (Subpart J). Returned and Salvaged Drug Products (Subpart K). Repacking and Relabeling. Bulk Pharmaceutical Chemicals. The Pharmacist and Total Quality Control. Recalls and CGMPs: Enforcement Alternatives in the United States. Controlled Substances Safeguards (21 CFR 1300, et seq.). The Inspection Procedure for Compliance in the United States: The Regulatee Is Inspected; The Rationale for Inspection (21 USC 373,374). FDA Pre-Approval Inspections/Investigations; The Road from SUPAC to the Food and Drug Modernization Act. Who is the Manufacturer? Some Additional Considerations for the Multinational. Other GMPs. Other Approaches to Quality. Import and Export of Pharmaceuticals and Other Products. Subject to CGMPs. Enhancement of Global Product Distribution. Appendices.