JVT Journal Articles
Vol. 13, Issue 1, Feb 2007

The purpose of this article is to define one of the design approaches that can be used to develop an autoclave cycle. The design approach discussed in this article is based on an overkill design approach from Parenteral Drug Association (PDA) Technical Monograph Number One and Six-Sigma Statistical Process Control. Many validation engineers in the...
The September 18, 2006 European edition of Time Magazine1 carried three interesting letters from readers on the subject of airline security and the related governmental risk control measures.
Paul L. Pluta, Ph.D.
JVT “Benchmarking” provides comments from respondents on questions or topics related to validation. Recent comments have indicated that validation and change control awareness – getting the elements of validation and change control considered in the daily activities of all levels in the organization – are areas of concern within the manufacturing...
This report summarizes the development and validation of an analytical procedure to support cleaning validation of pharmaceutical closures (stoppers). Based on current guidelines by regulatory agencies, a sensitive and quantitative test is needed to demonstrate the post-cleaning removal of cleaning agents from vial closures prior to their use....
Excellent responses to questions were received during the last months. Responses to Questions 11, 12, and 13 are reported below. Additional responses on questions from the last issues are requested; all questions and a brief summary of responses received to date are listed on the Website. The Website provides an easy method to respond to...
Although in theory, validation of Active Pharmaceutical Ingredients (APIs) may be the same as validation for dosage forms, in actual application they are not the same. The differences arise from the differences that exist between APIs and dosage forms in practicality. That is in their complexity, sheer size, robustness, and chemical or biological...