This all-inclusive special edition discusses the technical, regulatory, and validation aspects of facility, utility, and equipment qualification.

This all-inclusive special edition discusses the technical, regulatory, and validation aspects of facility, utility, and equipment qualification. 

A Practical Guide to Applying Impact and Risk Concepts to Equipment Qualification for Non-Critical Processes for Topical and Oral Product Applications
Miguel Montalvo

Design, Qualification, and Validation of Water Systems
Vineet Sharma

Recent FDA and International Regulatory Efforts Affecting Facility and Utility Systems Design and Qualification
Miguel Montalvo

A Practical Approach to Validation of HPLC Methods Under Current Good Manufacturing Practices
Ghulam A. Shabir

Equipment Qualification Toolkit
David M. Stephon

Basic Operating Principles and Validation of Electron Beam Irradiation Systems
Jorge A. Sugranes

Commissioning Issues and Considerations
Louis A. Angelucci, III

Validation of Time Synchronization
Rich Colvin

Qualification and Validation of Quality Control Laboratories
Mowafak Nassani, Ph.D.

Commentary – The Cubic Case Study: The Qualification/Validation of Equipment Under Changing Business Conditions
Charlie Neal