Title: The Certified Pharmaceutical GMP Professional Handbook, 2nd Edition Author: Mark Allen Durivage ISBN: 8174890491 / 9788174890498 Format: Hard Cover Pages: 516 Publisher: ASQ/Infotech Year: 2017 Availability: In Stock Special Indian Edition Priced at Rs.1695/-. FREE Shipping within India. Delivery : Within 2 to 4 working days.
Description
Contents
The purpose of this handbook is to assist individuals for the Certified Pharmaceutical Good Manufacturing Practices Professional (CPGP) examination and provide a reference for the practitioner. The second edition reflects the Body of Knowledge which was updated in 2015. This edition has also incorporated additional information including updated references. The updates reflect the current trends and expectations of the evolving pharmaceutical industry driven by consumer expectations and regulatory oversight.
This handbook covers compliance with good manufacturing practices (GMPs), as regulated and guided by national and international agencies for the pharmaceutical industry. It covers finished human and veterinary drugs and biologics, and combination devices, as well as their component raw materials (including active pharmaceutical ingredients (APIs) and excipients), and packaging and labeling operations.
List of Figures and Tables
Acronyms and Abbreviations
Preface
Acknowledgments
Part I : Regulatory Agency Governance
Chapter 1 : Global Regulatory Framework Chapter 2 : Regulations and Guidances Chapter 3 : Mutual Recognition Agreements Chapter 4 : Regulatory Inspections Chapter 5 : Enforcement Actions Chapter 6 : Regulatory Agency Reporting Chapter 7 : Site Master File (SMF), Validation Master Plan (VMP), Drug Master File (DMF), and Site Reference File (SRF)
Part II : Quality Systems
Chapter 8 : Quality Management System Chapter 9 : Quality Unit (Site) Management Chapter 10 : Risk Management Chapter 11 : Training and Personnel Qualifications Chapter 12 : Change Control and Management Chapter 13 : Investigations and Corrective and Preventive Action (CAPA) Chapter 14 : Audits and Self-Inspections Chapter 15 : Documents and Records Management Chapter 16 : Product Quality Complaints and Adverse Event Reports Chapter 17 : Product Trend Requirements Chapter 18 : Supplier and Contractor Quality Management
Part III : Laboratory Systems
Chapter 19 : Compendia (US, Europe, and Japan) Chapter 20 : Laboratory Investigations of Atypical Results Chapter 21 : Instrument Management Chapter 22 : Specifications Chapter 23 : Laboratory Record-Keeping and Data Requirements Chapter 24 : Laboratory Handling Controls Chapter 25 : Stability Programs Chapter 26 : Reserve Samples and Retains
Part IV : Infrastructure : Facilities, Utilities, Equipment
Chapter 27 : Facilities Chapter 28 : Cleanrooms Chapter 29 : Utilities Chapter 30 : Equipment Chapter 31 : Qualification and Validation Chapter 32 : Maintenance and Metrology Systems Chapter 33 : General Cleaning, Sanitization, and Pest Control Chapter 34 : Automated or Computerized Systems Chapter 35 : Societal Security - Business Continuity Management Systems
Part V : Materials Management and Supply Chain
Chapter 36 : Receipt of Materials Chapter 37 : Sampling Processes Chapter 38 : Material Storage, Identification, and Rotation Chapter 39 : Shipping and Distribution Chapter 40 : Traceability and Sourcing Chapter 41 : Salvaged/Returned Goods and Destruction
Part VI : Sterile and Nonsterile Manufacturing Systems
Chapter 42 : Master Batch and Completed Batch Records Chapter 43 : Production Operations Chapter 44 : In-Process Controls Chapter 45 : Dispensing and Weighing Controls Chapter 46 : Requirements for Critical Unit Processes Chapter 47 : Contamination and Cross-Contamination Chapter 48 : Reprocessed and Reworked Materials
Part VII : Filling, Packaging, Labeling
Chapter 49 : Filling Operations and Controls Chapter 50 : Environmental Monitoring Chapter 51 : In-Process and Finished Goods Inspections Chapter 52 : Product Inspection Chapter 53 : Packaging Operations and Controls Chapter 54 : Labeling Operations and Controls Chapter 55 : Filling and Packaging Records
Part VIII : Product Development and Technology Transfer
Chapter 56 : Quality by Design Concepts Chapter 57 : Phase-Appropriate GMP Requirements Chapter 58 : Raw Materials, Packaging, and Infrastructure for Product Development Chapter 59 : New Product Development Studies and Reports Chapter 60 : Scale-up and Transfer Activities
Appendix A : At-a-Glance Comparions
Appendix B : 21 CFR 211 Pharmaceuticals GMP Overview
Appendix C : 21 CFR 820 Medical Device GMP Overview
Appendix D : Body of Knowledge - Pharmaceutical GMP Professional Certification (CPGP)
Glossary
References and Suggested Reading
Index