Nally Good Manufacturing Practices for Pharmaceuticals

6. Auflage 2006
ISBN: 978-1-4200-2093-9
Verlag: Taylor & Francis
Format: PDF
Kopierschutz: 0 - No protection

E-Book, Englisch, 424 Seiten

Reihe: Drugs and the Pharmaceutical Sciences

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.

Zielgruppe

Pharmaceutical engineers; scientists involved in pharmaceutical manufacturing and control operations; GMP auditors; quality assurance and control professionals; contractors; industry consultants; and academics teaching in these subject areas.

Catalog no:

Autoren/Hrsg.

Nally, Joseph D.

Fachgebiete

• Wirtschaftswissenschaften Volkswirtschaftslehre Volkswirtschaftslehre Allgemein Industrielle Organisation

Inhaltsverzeichnis

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