About the Book:
Cleaning validation is not performed only to satisfy regulatory authorities. The safety of patients is the primary objective, and product contamination presents serious liability issues for any pharmaceutical manufacturer or contract organization.
The problem is that there are few formalized requirements for cleaning validation, and the supporting literature has been scarce as well. Setting up internal programs for cleaning validation involves a multitude of products and equipment; time, money, and people resources; and strong guidelines for getting started and following through with a comprehensive cleaning validation process.
Cleaning Validation: A Practical Approach offers a detailed, step-by-step guide for understanding and building an effective program by helping you define your objective, determine your approach, set policy, organize a program, and allocate adequate resources. From discussions on contamination types and control, you'll learn the basic concepts of cleaning, including mechanisms and levels of cleaning; the recommended procedures, materials and tools; how to set validation policy, including selecting appropriate groupings and sampling methods; contamination acceptance limits; program planning and execution, including accepted protocols; monitoring and maintaining your validation program; and special contamination issues and how to address them.
This "hands-on" practical approach to cleaning validation includes discussions on trends in control, procedures, cleaning agents and tools, sampling techniques, analytical methods, and regulatory issues, both now and in the future. More important, it provides practical examples, database formats, and valuable standard operating procedures, work instructions, protocols, and reports. Cleaning Validation will give you the tools you need to develop a clear and manageable program that will be acceptable to both U.S. and non-U.S. regulatory authorities. |
Contents: Part One - Developing a Cleaning Procedure 1. Contamination Control 2. Regulatory Requirements 3. Cleaning Basic Concepts 4. Cleaning Procedure Part Two - Developing a Cleaning Validation Program 5. Cleaning Validation Policy 6. Contamination Acceptance Limits 7. Cleaning Validation Planning & Execution 8. Cleaning Validation Monitoring & Maintenance 9. Special Cleaning Validation Issues 10. Cleaning Validation Trends Appendices: Cleaning & Cleaning Validation Procedures |
About the Authors:
Gil Bismuth, Senior Director in the Global Operations Unit of TEVA Pharmaceutical Industries Ltd., Israel, is responsible for Quality Management. He has a M. Pharm. degree from Hebrew University and previously served as the Head of Pharmaceutical Development, Responsible Pharmacist, and Director, Quality Assurance of TEVA's Pharmaceutical Operations Division. He co-authored a book on compliance auditing and is the president of the Israeli chapter of the Parenteral Drug Association.
Shosh Neumann, Director, Quality Assurance of TEVA Pharmaceutical Industries Ltd. Pharmaceutical Operations holds a B.S. in chemistry and physics, an M.S. in physical chemistry, and a PhD in applied chemistry from Hebrew University. Dr. Neumann's previous positions were Project Manager and Head of the Clinical Supplies Unit in the Innovative R&D Division, and Quality Assurance Manager of the solid dosage forms plant of TEVA's Pharmaceutical Operations Division. |
