With global harmonization of regulatory requirements and quality standards and national and global business consolidations ongoing at a fast pace, pharmaceutical manufacturers, suppliers, contractors, and distributors are impacted by continual change. Offering a wide assortment of policy and guidance document references and interpretations, this Sixth Edition is significantly expanded to reflect the increase of information and changing practices in CGMP regulation and pharmaceutical manufacturing and control practices worldwide. An essential companion for every pharmaceutical professional, this guide is updated and expanded by a team of industry experts, each member with extensive experience in industry or academic settings.
Table of Contents
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
"…What is especially valuable about these chapters is the degree of explanation which the authors have brought, and the appropriateness of the examples which they have used….
"…There are ample illustrations....deserves to be read and digested by anyone whose job it is to keep an operation on the proper side of the law."
-Pharmaceutical Development and Technology (for fourth edition)
"The chapters are clearly and concisely written, and provide the reader with the current regulations and practical discussions relating to interpretation of the guidelines....
"…I am pleased to add this edition to my bookshelf!"
-European Journal of Pharmaceutics and Biopharmaceutics (for fourth edition)
"…an invaluable text….help[s] any individual or student learn the application of the CGMPs."
-Pharmaceutical Research (for Fifth Edition)
"…excellent in presentation and language….a value to anyone interested in drug manufacture."
-American Journal of Pharmaceutical Education (for Fifth Edition)