GMP in Practice: Regulatory Expectations for the Pharmaceutical Industry, Fifth Edition, Revised & Expanded

Jul 2018
PDA Item Number
Hardcover: 17349 | Digital: 18054
Member Price
Nonmember Price

The Long-Awaited Revision and Update of GMP in Practice is Here!

Have you ever asked yourself, "Where in the Good Manufacturing Practices (GMPs) does it say I have to do _______?" If so, look no further than PDA's GMP in Practice: Regulatory Expectations for the Pharmaceutical Industry, fifth edition, Revised and Expanded.

As companies strive to harmonize global requirements for quality systems, the 5th edition of this text provides an overview of the 34 essential global cGMP requirements that are typically included in a modern pharmaceutical quality system, including data integrity and how they have evolved. Explore risk-related questions, delve into several expectations for each quality system element encompasses, and review real-world examples from cGMP regulations from the US FDA, Health Canada, the European Union, the World Health Organization, and the International Conference on Harmonization (ICH).

If you're looking for an enhanced understanding of GMP in practice, this text is a must-have for your reference collection.

Table of Contents

Table of Contents:
Click here to download >>>Detailed Table of Contents

  1. Management and Supervision Responsibilities
  2. Quality Risk Management
  3. Knowledge Management and Organizational Learning
  4. Quality Management and Quality Systems
  5. Product and Process Monitoring
  6. Discrepancy Observation and Investigation
  7. Complaints
  8. Qualification and Validation
  9. Learning, Training and Performance
  10. Documentation, Records and Recordkeeping
  11. Change Management
  12. Corrective Action and Preventive Action(CAPA)
  13. Materials and Packaging Components
  14. Vendors, Third Parties, and Outsourcing
  15. Sampling
  16. Sample Preparation and Analysis
  17. Testing and Analysis/QC Laboratory Operations
  18. Equipment Cleaning
  19. Sanitation
  20. Facilities and Utility Systems
  21. Warehousing and Storage
  22. Distribution Practices
  23. Maintenance, Repair, and Calibration
  24. Materials Receiving
  25. Equipment
  26. Manufacturing and Packaging: GMP Concepts
  27. Manufacturing and Packaging: Operations
  28. Identity Control
  29. Label Control
  30. Batch Release
  31. In-Process Controls
  32. AsepticOperations and Terminal Sterilization
  33. Clothing and Personal Hygiene
  34. Records and Data Integrity

About the Authors

About the Authors

James L. Vesper, Ph.D., MPH has worked in the pharma/biopharma industry for more than 35 years, starting out at Eli Lilly and Company where his last position was leading the GMP Training and Education group. For 24 years he was President of Learning Plus, a consultancy that provided training and performance solutions for industry. In 2017, he joined ValSource as Director of Learning Services. His professional interests are in the areas of learning/education, learning course design, risk management and incident investigations related to the category of "human error". Dr. Vesper has written numerous books. Book chapters and articles and also speaks and teaches at international conferences and workshops, as well as consulting for the World Health Organization. He holds a B.S. in Biology (Wheaton College, Illinois, USA), Masters of Public Health (University of Michigan School of Public Health) and Ph. D. in education (Murdoch University, Perth, Western Australia).

Tim Sandle, has over 25 years of experience in microbiological research and biopharmaceutical processing. He is Head of Microbiology at Bio Products Laboratory, U.K. and a visiting tutor with the School of Pharmacy and Pharmaceutical Sciences, University of Manchester. In addition, Dr. Sandle serves on several national and international committees relating to pharmaceutical microbiology and cleanroom contamination control, including the Pharmaceutical Microbiology Interest Group (Pharmig) and PDA technical working groups. He is also a member of several editorial boards for scientific journals. Dr. Sandle has written over 500 book chapters, peer reviewed papers and technical articles relating to microbiology. These include the PDA/DHI books Sterility Testing of Pharmaceutical Products, Risk Assessment and Management for Healthcare Manufacturing: Practical Tips and Case Studies, Cleanroom Microbiology as well as the book Pharmaceutical Microbiology: Essentials for Quality Assurance and Quality Control.