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
For Conferences Please Click Here
Don't miss this issue --SUBSCRIBE TODAY!