PDA DHI Technical Books

GMP In Practice Regulatory Expectations for the Pharmaceutical Industry, Fourth Edition, Revised & Expanded

by: James Vesper

As manufacturing and distribution practices get more complex and more global, manufacturers cannot just focus on one or two sets of requirements – it is too difficult to operate a quality system that has a multitude of variations to meet the individual requirements of a particular national authority.  Most multinational firms and those supplying global markets have done what national authorities have not – they have created quality systems and quality system elements that internally harmonize GMP expectations.  Yes, there still are some unique requirements that need to be met, but having a majority of requirements harmonized reduces duplication and increases flexibility.

GMP in Practice, 4th Edition is intended to help with that harmonization.  In it, we will look at more than 30 elements that are typically included in a modern pharmaceutical quality system.  Each quality system element has an overview section, some risk-related questions, and 3-10 expectations.  Each expectation is explored in a bit more detail and examples from GMP references from the US FDA, Health Canada, the European Union, the World Health Organization, and the International Conference on Harmonization (ICH) are presented. 

In order to get a rich understanding of GMP, a person needs to have knowledge of what various national authorities expect.  This book is designed to help you achieve this goal.


Table of Contents:
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  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. Documents, 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. Aseptic Processing
  33. Clothing and Personal Hygiene

About the Author

James L. Vesper designs and develops instructional courses and workshops for the pharmaceutical and medical device industries. He established and is president of the firm, LearningPlus, Inc. and has had more than 30 years experience in the pharmaceutical industry. Mr. Vesper worked eleven years at Eli Lilly and Company, Indianapolis. His last assignment there was Project Leader of GMP (Good Manufacturing Practice) Education and Instruction, establishing the department and its mission.

Since 1991, Mr. Vesper has been creating innovative instructional products for pharmaceutical firms using leader-led, video, and computer technologies as more effective and efficient delivery media. Working as consultants with a wide variety of clients, his firm creates integrated curricula for personnel and customized training courses targeted to particular needs. He provides workshops at various international technical and professional meetings. In 2001, he was awarded the PDA`s Agallaco Award for Excellence in Training. He is also the author of Risk Assessment and Risk Management in the Pharmaceutical Industry: Clear and Simple

As an author, Mr. Vesper has written several books and is the principle writer on a training guideline for the World Health Organization (WHO) that was published in 2007. He continues to work with the WHO as a consultant and advisor to WHO`s Vaccine Quality/Global Learning Opportunities.


Date of Publication: September 2011
ISBN Number: 1933722541
Format:
Number of Pages: 618
Binding: Hardcover