Process Validation

Apr 25, 2016
By Pharmaceutical Technology Editors
The agency publishes draft guidance on assay development and validation for immunogenicity testing.
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 author discusses the collection and evaluation of data part of FDA’s definition of process validation.
Jan 01, 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.
Sep 02, 2015
Pharmaceutical Technology
Siegfried Schmitt, principal consultant, PAREXEL, discusses how to assure compliance for automated systems.
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 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 02, 2015
Pharmaceutical Technology
The author reports results of evaluations and concludes that a disinfectant composed of a low-concentration suspension of silver ions is completely sporicidal with only a one-minute contact time.
Apr 16, 2015
Pharmaceutical Technology
By Pharmaceutical Technology Editors
At the request of FDA, US Marshals seize unapproved prescription drugs from Florida distributor.
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