The Journal of GXP Compliance
Vol. 25, Issue 1, Jan 2021

Tim Sandle
This article assesses the content of EN 17141: 2020 and discusses the points of importance, focusing on those which add value to those who are tasked with ensuring effective biocontamination control, as well as describing some areas of ambiguity, contradiction, and potential inaccuracy. These latter issues, in the context of pharmaceuticals and...
Siva Samy, Ajaz Hussain and Alton Johnson
In and beyond the COVID-19 pandemic, there is high uncertainty, anxiety, and eroding trust. Supply chain disruptions are juxtaposed with constrains on regulatory oversight, emergency use authorization, and unprecedented efforts by the life science sector to find therapeutic and vaccine solutions. The assurance patients and the public derive from...
Richard C. Wedlich and Kurt L. Moyer
The research worker is not left on their own to deal with the hazards they encounter daily in the chemical laboratory. Nor do they enter into such research without a minimum of safety training. Rather, they are part of a team that typically includes a lab manager or principal investigator and a Chemical Hygiene Officer. They receive continuous...
Tim Sandle
There is a continuing interest in the established and potential therapeutic properties of medical cannabis (1). These properties are due to cannabinoids, which are a group of compounds present in cannabis. As this interest continues, the quality of medicinal cannabis needs to be strengthened and the same standards applied as they would to any...
Marisol Avalos
Paul L. Pluta
Drug name errors occur in printed and written documents, in electronic systems, and in spoken words. Problems occur with both proprietary names and generic names. This discussion addresses drug name problems with the USA valproic acid family of drug products.
Karen R. Zimm
This paper builds on information provided in FDA Q&A on cGMPS. Additional information is provided to further explain and clarify CGMP policy regarding Preservative Effectiveness Testing. Questions and Answers on Current Good Manufacturing Practices, Production and Process Controls.
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 outlined in the publication “Effective Management of Post-Approval Changes in the Pharmaceutical Quality System (PQS) - Through Enhanced Science and Risk-Based Approaches Industry; One-Voice...
Kevin Lombardi
Nasir Egal
Post-approval changes (PACs) are inevitable and necessary throughout the lifecycle of pharmaceutical products - to implement new knowledge, maintain a state of control, and drive continual improvement. This 1VQ paper is part of a series of industry case studies and available to all industry professionals.
Tim Sandle
In this IVT Network blog we take a look at personalized medicines, citing some examples, and considering some of the technologies that help to make them happen. The author discusses advanced technologies such as biomarkers, big data analytics, genomics, 3D printing, and quantum computing.
Richard Forsyth
Given the current environment, there is a heightened global awareness around the need to sanitize our surroundings and practice, with diligence, our approach to cleaning. This process has always been a regulated and essential part of drug manufacturing, one the requires planning, validation and documentation. In this episode we learn some...
Chris Wubbolt
Working in a data driven industry, as life science leaders we understand that their decisions are only as good as the quality of their data. Ensuring data accuracy and consistency throughout its life cycle is was data integrity is all about. As we are all swimming in data, we must recognize that not all data is good data, nor is it necessarily...
Ghada Haddad
Lorianne Richter
Nuala Calnan
Vivian Rowland
Here our Risk Revolution team, Lori Richter and Nuala Calnan once again host their colleagues Ghada and Vivian for a robust conversation around the concept of risk curious and expand into the whys and hows with overviews of this practice under PICs. The group also reviews the need for training and development around risk, formalization of a risk...
Willis H. Thomas
In this episode of Voices in Validation we are talking about Human error in life science manufacturing. Human error is a major cause of GMP violations and deviations in pharmaceutical manufacturing - accounting for nearly 30% of quality defects. Efforts to investigate root causes are typically incomplete or poorly performed.
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