Graham P. Bunn
January 31, 2019 Forthcoming
Reference - 376 Pages - 50 B/W Illustrations
ISBN 9781498732062 - CAT# K26222
Series: Drugs and the Pharmaceutical Sciences
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This book provides insight into the world of pharmaceutical quality systems and the key elements that must be in place to change the business and organizational dynamics from task-oriented procedure-based cultures to truly integrated quality business systems that are self-detecting and correcting. Chapter flow has been changed to adopt a quality systems organization approach, and supporting chapters have been updated based on current hot topics including the impact of the worldwide supply chain complexity and current regulatory trends.
Status and Applicability of U.S. Regulations: Current Good Manufacturing Practices in Manufacturing, Processing, Packaging, and Holding 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 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 Current Good Manufacturing Contracting and Outsourcing. Active Pharmaceutical Ingredients. Bulk Pharmaceutical Excipient GMPs. Recalls, Warning Letters, Seizures, and Injunctions: CGMP 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 Scale-Up and Post-Approval Changes to the Food and Drug Modernization Act 319. Worldwide Good Manufacturing Practices. Quality Approaches: ISO 9000, Malcolm Baldrige, and Six Sigma. Appendices.