GMPs

Pharmaceutical Technology: Feb 24, 2015
By PharmTech Editors
The company voluntarily recalls product due to FDA observations of potential sterility problems.
Pharmaceutical Technology: Feb 23, 2015
By PharmTech Editors
The agency cites Apotex’s Bangalore facility with quality system failures.
Pharmaceutical Technology: Feb 02, 2015
Biosimilars, supply chain security, quality metrics, and elemental impurities headline guidance topics on FDA’s 2015 agenda.
PTSM: Pharmaceutical Technology Sourcing and Management: Dec 31, 2014
By PharmTech Editors
Analytical and procedural deficiencies result in FDA warning letter for Novacyl Wuxi Pharmaceutical.
Pharmaceutical Technology: Dec 02, 2014
The authors explore and define common industry approaches and practices when applying GMPs in early development.
Pharmaceutical Technology: Nov 01, 2014
The authors explore and define common industry approaches and practices when applying GMPs in early development.
Pharmaceutical Technology: 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.
Pharmaceutical Technology: 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.
Pharmaceutical Technology: Aug 31, 2014
Using a model quality risk-management process according to ICH Q9, the authors discuss ways to apply this guideline.
Pharmaceutical Technology: 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.