Journal of Validation Technology (JVT)

JVT provides useful information on processes and systems associated with pharmaceutical and medical device validation. General information on validation topics applicable to both pharma and biotech products and medical devices is also provided. Subjects addressed include manufacturing and packaging processes; cleaning processes; analytical methods; equipment, facilities, utilities, control systems; computer system qualification; and associated topics. The Journal embraces a comprehensive approach to validation. This includes design and development information conducted preliminary to validation and qualification, conformance testing that confirms development, and subsequent maintenance of the validated state. Information may include basic concepts, strategic approaches, laboratory studies, practical applications, experimental or process data, case studies, and expert commentary. Technical papers are peer reviewed.

JVT current or pending regular features supporting editorial strategy include:

Pharmaceutical Validation

• Aseptic Validation: Topics associated with aseptic processing, coordinated by Ed White

• Benchmarking: Reader Q&A addressing pharmaceutical process validation and associated issues, coordinated by Paul Pluta

• Biotech Processes: Technical aspects of biotechnology processes, coordinated by Michael Fetterolf

• Pharmaceutical Solids: Technical aspects of pharmaceutical solids, coordinator pending

• Pharmaceutics: Topics in pharmaceutics applicable to pharmaceutical and biotechnology products, coordinator pending

• Pharmaceutical Product Design: Topics of interest, coordinator pending

Medical Device Validation

• Medical Device Topics: Medical device topics of interest, coordinator pending

General Validation

• Analytical Validation: Topics of analytical laboratory interest, coordinated by Robert Kirsch

• Auditor Tales: Experiences and discussions by a GMP auditor, coordinated by Michael Anisfeld

• Computer Validation: Computer validation topics, coordinated by Bob Stotz

• Global Regulatory Viewpoint: Topics of regulatory, validation, and compliance interest including interviews with global regulatory personnel, coordinated by Richard Poska

• New Perspectives on Cleaning: Comprehensive approach to cleaning validation, coordinated by Rizwan Sharnez

• Statistical Viewpoint: Applications of statistics to compliance and validation, coordinated by David LeBlond

• Validation Learning Center: Basic topics in validation, coordinated by Paul Pluta

• Validation Strategy and Planning. Topics associated with strategy and planning, with focus on Validation Master Plans, coordinated by Stephen Perry

• Variation. Topics associated with identifying, controlling, and reducing variation, coordinator pending