The Journal of Validation Technology
Vol. 22, Issue 2, Apr 2016

The revision to Annex 15 takes into consideration changes to other sections of the EudraLex, Volume 4, Part I, relationship to Part II, Annex 11, ICH Q8, Q9, Q10 and Q11, QWP guidance on process validation, and changes in manufacturing technology. This revised guidance describes the principles of qualification and validation which are...
Tim Sandle
In an aseptic process, the drug product and container/closure are subjected to sterilization methods separately, as appropriate, and then brought together. This takes place under an aseptic environment, where the aseptic environment is separated from the general environment by some form of barrier. The aseptic environment is ISO class 5 (EU GMP...
Tim Sandle
A new regulatory consideration has arisen that affects pharmaceutical facilities of a certain vintage: the risks associated with the aging plant. In many more established areas of the world, pharmaceutical facilities are passing various time marks: thirty years, fifty years and even longer. As many pharmaceutical companies seek to establish...
Shelly J. Asmussen, Ph.D.
David G. Stroz, M.S.
David LeBlond
Dennis A. Stephens, Ph.D.
This publication describes how to convert degree-hour measures of over-temperature (OT) allowances to hours within a defined temperature range. Additionally, it will be shown how to derive the appropriate Hour Conversion Ratio (HCR) to convert a number of hours in a higher temperature Tier to an equivalent number in a lower Tier for accounting...
Orlando Lopez
This article covers electronic records (e-records) integrity topics associated with data warehouse (DW) and business intelligence (BI) environments. The data integrity related definitions used in this article are based on MHRA recent guidance document.
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