The Journal of Validation Technology
Vol. 27, Issue 6, Dec 2021

Paul L. Pluta
Revision of the ICH Q9 Quality Risk Management (QRM) guideline was released for public comment in December 2021. In the EU, the public consultation period begins on mid December and will continue for 3 months. ICH Q9 is a key guideline associated with risk-based change management and validation. The original version of ICH Q9 was issued more than...
Ajay Babu Pazhayattil
This article provides a structured framework for professionals to apply a patient focused approach, in line with current regulator thinking, applying scientific principles while developing a qualification plan for critical aseptic parenteral manufacturing equipment and systems. The proposed model [Figure 2] can bring equipment qualification...
Paul L. Pluta
Cleaning is required in many applications, and numerous specialized topics are relevant to cleaning. Often the range of topics in cleaning is overwhelming. Some personnel cannot understand differences in cleaning – critical cleaning vs. general cleaning. Some subject matter experts (SME’s) have extensive expertise in certain aspects of cleaning...
Alan M Golden
This paper examines basic concepts in statistics and their application to validation. It explores the definition of statistics, why statistics are important in validation, and the regulatory requirements for statistics in processes. It further addresses the concept and measurement of variance, data distribution, and the relationship of variance to...
In GMP regulated environments maintaining proper records and documentation is critical to data integrity, regulatory compliance and GMP best practices. Starting with Part 11 more than two decades ago, we’ve seen an emphasis on good record keeping and a shift to paperless. Still, paper-based systems are prevalent around the world, but given our...
This week, Stacey chats with Rich Forsyth about understanding the results of testing, and reproducibility of test results under varying conditions allows for consistency across teams and lessens the risk of error in cleaning validation activities.
Alex Castro
Biases is a very interesting topic, and one that we take very seriously in life science manufacturing, as it can impact the quality of the product and add undo risk in this highly regulated environment. Interestingly, many do not consider their personal biases and the impacts on our decision-making and general ways of thinking.
Nuala Calnan
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Tim Sandle
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Valerie Mulholland
This week our series coordinator Nuala, is joined once again by a regular Risk Revolution contributor, Valerie Mulholland, to close out the year with a lively discussion with another old friend of the IVT network, Dr Tim Sandle.
Alan M Golden
In this episode we share a session from Validation Week on the topic of Integrating Risk into Change Control. Everything we do in this industry should take into account Risk. Our guest Alan Golden talks about changes driven by risk, and conversely risk updates driven by change, as well as risk integration.
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