GMPs

Dec 02, 2014
The authors explore and define common industry approaches and practices when applying GMPs in early development.
Nov 01, 2014
The authors explore and define common industry approaches and practices when applying GMPs in early development.
Oct 01, 2014
A risk-based guard band surrounds a specification limit and is derived from the uncertainty of the reportable value of the analytical procedure, which includes the uncertainty in the reference standard. The author discusses requirements for generating a reportable value and calculating the associated measurement uncertainty.
Oct 01, 2014
The recovery of an occasional mold does not merit any particular concern. On the other hand, evidence of mold proliferation indicative of infection of facilities or equipment must be taken seriously and requires the prompt implementation of corrective and preventive actions.
Aug 31, 2014
Using a model quality risk-management process according to ICH Q9, the authors discuss ways to apply this guideline.
Aug 01, 2014
The latest revisions to the USP General Chapters <41> Balances and <1251> Weighing on an Analytical Balance aim to ensure weighing accuracy and eliminate unnecessary overtesting by simplifying previous descriptions and reflecting current state-of-the-art weighing practices.
Jul 15, 2014
By PharmTech Editors
Trifarma cited for significant deviations in data collection and security, and employee training.
Jul 01, 2014
The authors look at the cleanability of pharmaceutical soils from a variety of materials of construction to determine the relative ease of cleaning and explore potential grouping strategies as part of a comprehensive cleaning validation program.
Jul 01, 2014
Nitrogen dioxide can sterilize and depyrogenate an aseptic fill area in a blow-fill-seal process.
Jul 01, 2014
Siegfried Schmitt, Principal Consultant, PAREXEL International, discusses how to ensure data integrity.