The Journal of Validation Technology
Vol. 21, Issue 1, May 2015

In recent years the industry has been moving towards the implementation of a risk based computer validation approach. This creates the challenge about how to implement a risk-based computer validation program. This article will discuss ideas about how to implement a risk based approach computer validation program.
Tim Sandle
This paper uses one example of a risk assessment approach to illustrate how risk assessment can be incorporated into good manufacturing controls. The specific activity assessed involves transferring a set of sterilised stoppers from an autoclave to a filling machine within a sterile manufacturing facility. The risk assessment approach adopted is...
Rizwan Sharnez, Angela To, and S. Ravi Annapragada
Methodologies for estimating experimental parameters for small-scale cleaning characterization are described in this series: dilution of process fluids during clean-in-place (CIP) operations was discussed in Part I (1); the effect of fluid velocity on the kinetics of cleaning is described in this part; the effect of humidity, hold time and soil...
Tim Sandle
This paper addresses some of the risk considerations that must be evaluated when replacing a steam sterilizing autoclave within a pharmaceutical processing facility. It demonstrates the application of Failure Modes and Effects Analysis (FMEA) for assessment of risk as part of quality risk management. Tables for classifying these aspects are...
Liem Ferryanto, Ph.D.
A practical step by step process on selecting and applying statistical sampling plans and acceptance criteria for the verification and validation is presented and then applied to some cases related to medical devices products and processes.
Paul L. Pluta
In partnership with the Journal of Validation Technology, the Journal of GXP Compliance is pleased to present this "PQ Forum" review. “PQ Forum” is an ongoing feature in the Journal of Validation Technology (JVT) that provides a forum for validation practitioners to share information about Validation Stage 2 Process Qualification (PQ)...
On March 18 at the 6th Annual EU Validation Week, IVT Network hosted a senior-level think tank entitled, “Strategies for the Advanced Validation Professional.” This session was hosted by Ivan Soto, contributing editor for IVT and associate director of QA Validation at Alexion.
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