The Journal of Validation Technology
Vol. 25, Issue 3, Jun 2019

Stacey L. Bruzzese
This publication is made for the Quality Control, Assurance and Validation experts concerned with best practices and continuous improvement in their respective fields. Our featured authors are industry experts themselves, and generously share their insights and experiences for the benefit of all.
Paul L. Pluta
CQV #6 is part of a series of articles addressing the detail-oriented processes necessary for compliance. In this article learn more about the Validation Approval Committee in pharmaceutical manufacturing.
Yeong-Lin Chen
The medical device industry faces cumbersome process validation requirements making the Operational Qualification process a challenge in both manufacturing and testing. This article provides some simplified approaches to relieve some of the burden.
Tim Sandle
This paper looks at how acclimatization might be achieved, in the context of method verification. The paper begins by looking at the objectives of method verification and then considers the appropriateness of environmental isolates in expanding microbial test panels. The paper then considers the how it can be ensured that environmental isolates...
Ivan Soto
This article discusses the latest guidelines on how to implement a risk-based analytical instrument qualification process in alignment with USP <1058>.
Paul L. Pluta
“PQ Forum” provides a mechanism for validation practitioners to share information about Stage 2 Process Qualification PPQ in the validation lifecycle. Information about supporting activities such as design and development, equipment, and analytical validation will also be shared. The information provided should be helpful and practical so as to...
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