Process Validation

Apr 02, 2016
Pharmaceutical Technology
Visible residue limits have been shown to be a valuable tool in validated cleaning validation program.
Jan 02, 2016
Pharmaceutical Technology
The 10-ppm criterion for the acceptable concentration of potential API in cleaning validation to minimize cross contamination into next product has been employed for many years. This article describes why the 10-ppm criterion, which was established based on analytical limitations and estimates of acceptability, is no longer necessary and why a risk-based approach should be universally adopted.
Jan 02, 2016
Pharmaceutical Technology
The author discusses the collection and evaluation of data part of FDA’s definition of process validation.
Sep 02, 2015
Pharmaceutical Technology
Siegfried Schmitt, principal consultant, PAREXEL, discusses how to assure compliance for automated systems.
Jul 14, 2015
By Pharmaceutical Technology Editors
The new sizes follow the 2014 launch of the company’s fully disposable purifier.
Jul 01, 2015
Pharmaceutical Technology
An ISPE guidance document, four years in the making, brings risk-based thinking, statistics, and Lean Six Sigma to cleaning validation.
Jun 29, 2015
By Pharmaceutical Technology Editors
The new column features Natrix’s signature macroporous hydrogel.
Jun 17, 2015
Equipment and Processing Report
Presenters at IVT's Microbiology Week discussed best practices and recent guidance publications for microbial control in sterile and non-sterile pharmaceutical processes.
May 22, 2015
By Pharmaceutical Technology Editors
Pharmaceutical Technology spoke with Tim Kearns, pharmaceutical and medical devices manager at Videojet.
May 21, 2015
By Pharmaceutical Technology Editors
Medicago's new production facility will make plant-based vaccines and therapeutics.
native1_300x100
lorem ipsum