The Journal of Validation Technology
Vol. 28, Issue 2, Apr 2022

Brad Bartels
,
Paul L. Pluta
Calculations Roundtable is a new IVT feature that will provide readers an opportunity to discuss typical calculations related to pharmaceutical compounding and product use. Correct product calculations are vital in product design, development, and analysis. After commercialization, calculations are equally vital in healthcare practice including...
Nishant B. Thakar
,
Paul L. Pluta
Compounding Forum (CF) is a new IVT feature that will provide readers an opportunity to discuss pharmaceutical compounded formulations, processes, problems, and related topics. Pharmaceutical compounding is a specialized skill based on principles of science. The New England Compounding Center disaster in 2012 alerted the entire world population...
The much-discussed revision to the EU GMP Annex 1 is expected to be published early this year, bringing some major changes to drug developers’ current process and manufacturing methods for sterile products. Although the draft revision has been widely shared and commented on, it is still unclear the total impact this document may have across...
David B. LaTart
The pharmaceutical quality control laboratory serves one of the most important functions in pharmaceutical production and control. Poor laboratory practices may yield compliance issues, higher costs, increased cycle time, and delayed product introductions. Avoiding all that means consistent lab review processes and good document controls. In this...
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