The Journal of Validation Technology
Vol. 27, Issue 4, Aug 2021

Gabriella del Hierro, Emily Holz, Ed Contreras, Pauline Che, Shelley Elvington, Ho Young Lee, and Adeyma Arroyo
The calculation of cleaning carryover limits in multi-product facilities can be based on the inactivity of molecules after exposure to cleaning conditions if the inactivation of active molecules can be demonstrated. The demonstration of inactivation has been addressed in several publications that have shown degradation and/or denaturation using...
Yeong-Lin Chen
This article proposes a risk-based revalidation approach with a simple and pragmatic risk assessment method for mechanical-type medical device manufacturing. Use the risk assessment output in conjunction with initial validation approach as well as product, equipment and process characteristics, a risk-based revalidation approach can be determined...
Orlando Lopez
This article provides a breakdown of an interesting US FDA Warning Letter. This Warning Letter is an excellent example of the remediation activities required by the US FDA when inefficiencies are found around access authorization. On 5 December 2019, the US FDA issued a Warning Letter (320-20-10) to the Australian firm Tismor Health and Wellness...
Paul L. Pluta
A carefully written Validation Plan including thoughtful discussion in its respective sections ensures a logical and complete validation project. The following discussion proposes a simple and straightforward Validation Plan document structure that is applicable to all validation/qualification at a pharma manufacturing site.
Siegfried Schmitt
Regulations worldwide tell us that a Pharmaceutical Quality System has to be risk-based. In reviewing best practices and ICH Q9 guidelines on QRM, the author shares insights on what not to do, using examples the author has come across over the more than 30 years in industry.
Paul L. Pluta
This case study describes an abrupt and unexpected technical manufacturing problem caused by changes in the physical properties of a formulation ingredient. Manufacturing of a validated process could not be accomplished despite recently completed successful validation. Investigation determined a technical root cause, and also identified problems...
Jeremy M. Ebersole
Paul L. Pluta
Statistics Roundtable is a new IVT feature that will provide readers an opportunity to discuss information about statistics and demonstrate the application of statistics to pharmaceutical problems. The use of statistics is fundamental in regulated industries. The statistical basis for decision-making is an expectation. Any effort to increase the...
Tim Sandle
Coronavirus control measures remain a central concern for workplaces, especially with more employers encouraging a return to office (or some form of hybrid working). This article looks at the indoor climatic conditions most conducive to coronavirus survival and, based on these risk factors, considers the optimal mitigation measures that can be...
Tim Sandle
One of the dilemmas facing the quality risk management function is with a series of completed risk assessments and a series of multiple outcomes that require addressing, in the context of limited resources. When faced with multiple risks, how are these to be prioritized?
Tim Sandle
Contamination control encompasses all aspects of contamination such as particulate, microbial, product carryover, chemical (like cleaning material residues) as well as viral. Developing an effective contamination control strategy is important to patient safety and the integrity of the drug. Of course, any strategy that may be adopted starts with...
Lorianne Richter
Martin Lipa
Nuala Calnan
In this episode the Risk Revolution team speaks with guest Marty Lipa about the Risk Knowledge Infinity Cycle. As well as the ways Risk Management and Knowledge Management work together to provide a more effective Quality Management System, ultimately protecting the safety of our patients. Hear more on the two enablers to building an effective...
It’s an exciting time for women in STEM as opportunities from bench to boardroom abound. Pharma leaders are called upon to be the combined voice, lending strength and perseverance in support of diversity. Listen to a panel discussion which was recorded during a live LinkedIn session in collaboration with Woman to Woman podcast.
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