The Journal of GXP Compliance
Vol. 24, Issue 2, Mar 2020

Tim Sandle
This paper reviews the new draft. In doing so the focus is on those aspects that are different to the 2017 draft, rather than spending much time comparing the 2020 draft with the current Annex 1 (which is dated 2009). Readers wishing to do this can refer to the 2018 Journal of GxP Compliance review. The reader should note that this paper contains...
Paul L. Pluta
Why is it important to contribute to industry publications? If you are curious about what is in it for you - this episode will offer some insight. We welcome Paul Pluta, Editor-In-Chief of the Journals of Validation Technologies and GXP Compliance sharing his thoughts on the professional and personal gain to be had by authoring or peer reviewing...
Jeanne Moldenhauer
In 2017, the European Union (EU) issued a draft revision to the EU GMPs Annex 1 – Manufacture of Sterile Products. This document generated a large response from pharmaceutical companies, and they provided many comments to the regulators.  Following the review of these comments the long-awaited changes were incorporated into a...
Stacey L. Bruzzese
<p>Interested in our member&#39;s and their interests, IVT Network has been granted an opportunity to represent you &mdash;&nbsp;relevant stakeholders, in the second consultation. Further, IVT has agreed to receive all the comments of this second consultation from our members, to compile and return to the European Commission....
Isi Veitia, Reinaldo Blanco, Dany Miranda, Odalys Pérez, Yeleiny Machín, Duniesky Martínez, Dayamí Dorta, Ronny Camacho, Adaleikys Marrero, Joel Pérez, Bárbara López, Enrique Pérez
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Rodolfo Valdés Véliz
This article presents data about the selection of stable hybridoma clone and the characterization of the monoclonal antibody produced by the sable hybridoma clone to be used in the Hepatitis B diagnosis in Cuba. In Cuba, this disease is routinely diagnosed by a validated UMELISA® HBsAg Plus test, the main component of this diagnosis kit is the...
Karolina Cieslak and Varanya Chaiyaperm
Medication errors associated with the use of epinephrine products and medical devices are a significant healthcare problem. Epinephrine is a high-alert medication; erroneous use of epinephrine bears a high risk of causing significant patient harm. Medication safety problems associated with the design and use of epinephrine products are described...
Karen R. Zimm and Renee King-Alliego
A field alert report (FAR) is an important mechanism by which a potential safety threat in a drug product can be quickly identified and managed. The overview of FARs and means of handling them is the theme of this Regulatory 101 article. Regulatory 101 is a regular column which provides "back to basics" information for industry...
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