The Journal of Validation Technology
Vol. 26, Issue 6, Dec 2020

Emma Ramnarine
,
Richard Rolke
This One-Voice-of-Quality (1VQ) position paper is part of a series of industry case studies intended to demonstrate the standard application of the principles of One-Voice-of-Quality (1VQ) Solutions. This paper describes changes to analytical equipment that are considered ‘like for like’ or equivalent. The conclusion drawn from this case study is...
Paul L. Pluta
Validation documents are critical documents. Validation documents are the permanent record of site technical development supporting the manufacturing and commercial distribution of pharmaceutical products that are administered to patients. They must be carefully written in a logical format for reading by internal and external reviewers including...
Kevin Lombardi
,
Nasir Egal
This 1VQ paper is part of a series of industry case studies and available to non-members here http://blog.cbinet.com/one-voice-of-quality. In this case study, the risk associated with the extension of shelf-life was evaluated. The conclusion drawn is that shelf-life extension changes when controlled effectively as described in this paper, present...
Allan Marinelli
Work life in pharma and many other industries has been significantly affected during the past year. COVID-19 has caused organization changes, working remotely, virtual meetings, civic lockdowns, service interruptions, and other changes intended to minimize health risks associated with the pandemic. All participants connected with project team...
Ivan Soto
The Coronavirus has impacted for all businesses in the pharmaceutical and biotechnology industry across every functional area including validation. The pandemic this year allowed for fewer staff onsite supporting validation activities. These challenges and more, in the wake of COVID, are compounded by the threat of infection in essential workers....
Paul L. Pluta
A revision to ICH Q9 Quality Risk Management (QRM) has been recently approved by the ICH Management Committee (1). ICH Q9 is a key document associated with change management and validation. The original ICH Q9 was issued more than 10 years ago. The following manuscript's key points associated with the revision as expressed in ICH documents.
Ghada Haddad
,
Lorianne Richter
,
Nuala Calnan
,
Vivian Rowland
Another episode of Risk Revolution, a monthly series of the Voices in Validation podcast, brought to you by the IVT Network. The goal of this series is to advance the maturity of risk management practices within the industry, by covering topics that challenge quality professionals to seek opportunities to improve and advance the ways in which they...
Tim Sandle
Throughout history humankind has found ways to modify and adorn themselves allowing for unique identification within their tribe, or society as a whole, and taken comfort in shared activities with kin. This has never been more popular than it is today with adornments such as various piercings, tattoos, nail and hair extensions, tanning and more...
Emma Ramnarine
This is a follow-up to Part 1 of this series, where we introduced the concept of One-Voice-of-Quality to our listeners and had a chance to really lay out the ramifications of failure to change, not only in the Post Approval Change process, but the mindset around the implementation of a global regulatory framework. In this latest episode - Part 2,...
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