The Journal of Validation Technology
Vol. 27, Issue 1, Feb 2021

Tim Sandle
Taking the real-world struggle to validate an ionized hydrogen peroxide system and seeking evidence to explain why this might be the case, it is evident there is a lack of peer reviewed literature discussing this technology for decontamination and its application within the pharmaceutical sector. This article looks at ionized hydrogen peroxide, in...
Ivan Soto
The coronavirus has impacted all businesses in the pharmaceutical and biotechnology industry across every functional area including validation. The pandemic has prevented resources from being onsite to support routine validation activities. Although most companies in the industry have Business Continuity Plans, most of them were not detailed or...
Sanjay Sharma, Amol Galande, Ajay Babu Pazhayattil, and Jordan Collins
This paper delivers structured techniques for science- and risk-based continual process improvement decision making with Stage 3 heightened sampling and testing of oral powder for suspension products. The prognostic study uses sound pharmaceutical manufacturing science principles along with proven statistical tools. The methods are applicable for...
Paul L. Pluta
Validation documents are critical documents in a pharma manufacturing facility. They are the permanent records of site technical work supporting the manufacturing of drug products and medical devices. These documents must be carefully written for internal and external reviews including audits by regulatory inspectors. Validation documents may be...
Allan Marinelli
Conducting a risk analysis on systems is more pertinent today than ever. Companies cannot afford to test every single attribute as part of the process/system design with results having little or no significant impact on quality and/or on GxP systems. Whether control systems, computerized systems, automation systems, information technology...
Ivan Soto
The traditional change management process is riddled with inefficiencies and duplication. Change management processes that are intended to be different in nature end up being significantly similar and overly restrictive. To align with current industry guidance and standards companies should consider implementing a risk-based change management...
D. Abreu Remedios, M. Delgado Rigo, Y. Machin Leon, D. Dorta Hernandez, M. Suarez Pedroso, Y Sordo Puga, Y. Cabrera Artiles, O. Valdivia Perez, E. Perez Cruz, and C. Hernandez Diaz
Classical swine fever (CSF) is a highly contagious viral disease of domestic pigs and wild boars which causes great economic losses, due to high mortality rates Vaccination is a key strategy for the prevention and control of Classical Swine Fever in developing countries. To validate the efficacy of the vaccine, a simple and rapid routine test is...
Paul L. Pluta
This review describes the recently-published Principles of Parenteral Solution Validation, A Practical Lifecycle Approach, edited by Igor Gorsky and Harold S. Baseman. This book is part of the Expertise in Pharmaceutical Process Technology series published by Academic Press (Elsevier) and edited by Michael Levin. Igor Gorsky is a member of the...
Ajaz S. Hussain
,
Alton Johnson
,
Steven D. Thompson
As we continue to face business impacts of COVID, a new normal may be emerging in regulated industries, such as pharma and medical devices, when it comes to site visits and audits. As agencies like the FDA continue to rely on the virtual inspection, we need to take a look at the process, including review of documents and processes. How can these...
Harsha Chulki
,
Stephen Cook
Validation documents are critical to both the internal processes, and external communications, in regulated industries such as pharmaceutical and medical device organizations. Properly recording and managing data is necessary to ensure the integrity and reliability of records. Good Documentation Practices (GDP) lay down the guidelines for...
Lorianne Richter
,
Nuala Calnan
,
Valerie Mulholland
This week our series coordinators, Lori and Nuala, will engage their guest Valerie Mulholland in a lively discussion on a critical aspect of Risk Management, namely the skills and confidence necessary to making effective and timely risk-based decisions.
Rick Rhoads
Traditionally, compounding pharmacists have relied on professional experience and published data to determine product stability. Based on this knowledge, compounders have extended beyond use dates when deemed safe and effective. With rapidly changing guidelines, these kinds of judgement calls are no longer allowable in some states such as...
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