The Journal of Validation Technology
Vol. 25, Issue 6, Dec 2019

Eshetu L Haile, Birhanu Hurisa, Blen Girma, Sintayehu Ashenafi, Dejene Getachew, Bedasa Gidisa, Hailu Lema, Abebe Mengesha, Demise Mulugeta, Gashaw Gebrewold, and Dereje Nigussie
GMP compliance audit has impacted daily vaccine production processes which introduce quality assurance principles (3,4) into all steps involved in the manufacturing process. This article discusses the World Health Organization approach to quality and GMP as it pertains to vaccines and vaccine production.
Lorianne Richter; Anne Greene
This article represents the second, in a three-part series on overall effectiveness of the pharmaceutical CGMP training program. This second article focuses on how various training modalities discussed in the first article are fulfilling adult learning needs or creating shortcomings in the adult learning experiences, which likely result in a less...
Denise Diehr-New
Data Integrity is a timely and well-discussed topic in the pharmaceutical industry. The regulatory agencies demand it, the pharma companies aim to provide it, and the patient depends upon it. Although it may seem straightforward, there are many factors impeding the zero-findings review. Computerized Systems Validation (CSV) teams have a large...
Steven D. Thompson
FDA launched the Case for Quality in 2011 to achieve better patient outcomes by raising quality and safety levels among all medical device stakeholders. This program intended that organizations would advance beyond strictly complying with regulation towards achieving better sustained and predictive practices. You can foresee this requiring a...
Emma Ramnarine, Anders Vinther, Anne Greene, and Kevin O'Donnell
Product quality and patient safety have been foundational and at the core of pharmaceutical regulations and operations for decades. The history of quality management can be traced back to the Middle Ages, where the focus was for a finished product to meet all quality standards ensuring customer satisfaction. This article explores the evolution of...
Paul L. Pluta
This discussion addresses the writing of units of measure in validation and other technical documents. Writing units of measure may violate technical writing norms, be inconsistently presented within documents, and have grammatical mistakes. Basic technical writing rules for unit terms and examples of common errors are described. Rules for...
Ivan Soto
Shipping validation is another critical component of the entire product lifecycle. Shipping validation issues can have a negative impact on the business, patient, and compliance. Companies must have an adequate document hierarchy that aligns with current industry standards to accomplish an acceptable shipping validation process. This article...
Validation Master Plan Download banner