Good Manufacturing Practices for Pharmaceuticals

Status and Applicability of U.S. Regulations. 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 Control (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. Quality Systems and Risk Management Approaches. Clinical Trial Supplies and GMPs. Contracting and Outsourcing. Active Pharmaceutical Ingredients. Bulk Pharmaceutical Excipient GMPs. Recalls, Warning Letter, Seizures and Injunctions: CGMP Enforcement Alternatives in the United States. Controlled Substances Safeguards. The Inspection Procedure for Compliance in the United States: The Regulatee Is Inspected; The Rationale for Inspection. FDA Pre-Approval Inspections/Investigations: The Road from SUPAC to the Food and Drug Modernization Act. Worldwide GMPs. Quality Approaches: ISO 9000, Malcolm Baldrige and Six Sigma. Appendix A: Center for Drug Evaluation and Research (CDER) List of Guidance Documents. Appendix B: ICH Guidelines. Appendix C: FDA / ORA Compliance Policy Guides