The Journal of Validation Technology
Vol. 26, Issue 3, Jun 2020

Paul L. Pluta
,
Stacey L. Bruzzese
Pharma managers in the US and Europe have expressed that they simply do not have time to talk about management. They are too busy fighting fires in their plants, approving protocols, releasing batches, doing investigations, fixing problems, responding to emergencies, and so on - doing the activities essential to their respective site businesses...
Kevin O’Donnell, Deidre Tobin, Stephanie Butler, Ghada Haddad, and Donal Kelleher
Formality in Quality Risk Management (QRM) is an interesting concept. What makes a QRM activity ‘formal’ and what makes one ‘informal’? A simplistic viewpoint might be that formal is when a QRM tool is used to manage risks, and informal is when no such tool is used. But is it that simple? And are there different degrees of formality in QRM - is...
Paul L. Pluta
,
Richard Poska
This commentary was submitted to FDA in response to their publishing of the titled draft guidance. It is posted on the FDA website.  IVT also published a summary of the guidance (Poska, JGXP Volume 24. #3) that is reprinted in this issue of JVT. A link to the entire FDA draft guidance is also provided (Docket # FDA-2019-...
Richard Poska
The FDA previously published Guidance for Industry: Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products (1) in 2013. This document provided guidance on injector design, materials of construction, performance testing, sterilization, and labelling. FDA has now drafted Technical...
Daniel O'Regan and Cliff Campbell
This paper highlights the practical benefits to the industry, of adopting the concept of the ‘Spectrum of Importance’ (SOFI) an alternate approach to understanding and prioritizing process parameters. This approach represents a move away from the current binary critical/non-critical one that is widely used by many companies today; instead, it...
Tim Sandle
The COVID-19 pandemic (caused by the SARS-CoV-2 betacoronavirus) has forced many pharmaceutical companies to reorganize their operations and to foster in remote working.
Allan Marinelli
There are many methods or ways of writing a Periodic IT/Automation System Evaluation Report (PER or PSE) with respect to automated manufacturing equipment (Bioreactors, Centrifuges, Autoclaves, etc.), utilities systems (Water For Injection, Purified Water, Heating Ventilation and Air Conditioning) information technology platforms/software,...
Eric Kastango
On this episode of Voices in Validation we welcome Eric Kastango to the show. Stacey and Eric discuss the FDA's implementation of temporary guidances and how compounders can mitigate their risks to consumers and clinical sites. Included in the discussion are thoughts on pre and post-COVID guidances, the unique abilities of both 503A and 503B...
Mayte Quintana, Williams Ferro, Airela Llamo, Tatiana González, Miguel Castillo, Yenisley Medina, Yanet Villegas, and Rodolfo Valdés
This article presents data about the characterization of different ligand densities in the immune sorbents used in the immunoaffinity chromatography applied to purify of the active pharmaceutical ingredient of the Cuban Hepatitis B vaccines. This evaluation is very important to know the exact ligand density than should be used to bring down cost...
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