GMPs

PTSM: Pharmaceutical Technology Sourcing and Management: Mar 30, 2015
By Pharmaceutical Technology Editors
A consensus-based standard issued by NSF International incorporates regulatory and industry requirements into a single standard for the manufacturing and distribution of pharmaceutical excipients.
Mar 13, 2015
By Pharmaceutical Technology Editors
McNeil-PPC pleads guilty in connection with adulterated infants' and children's over-the-counter liquid medications.
Pharmaceutical Technology: Mar 02, 2015
Cleanability is crucial when choosing components for GMP manufacturing areas.
Pharmaceutical Technology: Feb 24, 2015
By Pharmaceutical Technology Editors
The company voluntarily recalls product due to FDA observations of potential sterility problems.
Pharmaceutical Technology: Feb 23, 2015
By Pharmaceutical Technology 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 Pharmaceutical Technology 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 02, 2014
The authors explore and define common industry approaches and practices when applying GMPs in early development.
Pharmaceutical Technology: Oct 02, 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.