IVT is offering a new Special Edition on Facility Qualification. This exclusive book with over 135 pages of information that you cannot find anywhere else is now available for the first time. Issues reviewed in this edition include: validation policy, required documentation for the validation of manufacturing equipment, validation master plan, project master plan, equipment qualification, prospective qualification, retrospective qualification, analytical methods, and cleaning validation.  

The Special Edition: Facility Qualification includes the following articles:

• Validation Concept for a Plasma Fractionation and Parenteral Drug Manufacturing Facility
• Validation of a Consumer Healthcare Facility
• Validation without Tears: Getting Started
• Front-End Planning for cGMP Facility Expansion
• Global GMP Regulations for Designing a Solid Dosage Form Facility
• Facility Validation: Management Issues
• Performance Qualification of a Cleanroom from a Quality Perspective
• Validation of Existing Facilities: A Systematic Approach to Facility Qualification
• Validating Building Controls Systems
• Validation Commissioning Documents: A Checklist Approach for Facility Validation
• Validation/Qualification and Commissioning Strategies for Major Capital Projects: A Case Study
• Commissioning Issues and Considerations
• Facility Validation: A Case Study for Integrating and Streamlining the Validation Approach to Reduce Project Resources
• Qualification of Environmental Chambers
• Facility Validation: Validating USP Purified Water, Compressed Air, and HVAC Systems

This Special Edition on Facility Qualification is full of examples, charts, graphs, and articles written by leading validation professionals from such companies as:

• Alcon Laboratories, Inc.
• Almedica Services Corporation
• Eli Lilly and Company
• Genetic Systems Corporation, a Division of Sanofi Diagnostics, Inc.
• ZLB Central Laboratory Blood Transfusion Service SRC
• Pfizer Global Manufacturing
• SmithKline Beecham Consumer Healthcare
• Research Institute for Industrial Pharmacy