GMPs

May 11, 2015
By Pharmaceutical Technology Editors
FDA issues a Form 483 following inspection of Impax Laboratories' Hayward, CA facility.
May 04, 2015
PTSM: Pharmaceutical Technology Sourcing and Management
By Pharmaceutical Technology Editors
FDA cites Yunnan Hande Bio-Tech for cGMP violations related to data collection and security.
May 01, 2015
The revised "21st Century Cures” proposal includes provisions for research for continuous manufacturing, biomarker development, and NIH funding.
Apr 16, 2015
Pharmaceutical Technology
By Pharmaceutical Technology Editors
At the request of FDA, US Marshals seize unapproved prescription drugs from Florida distributor.
Apr 10, 2015
Pharmaceutical Technology
By Pharmaceutical Technology Editors
FDA issues a Warning Letter to Hospira S.p.A. for GMP violations at the company’s Liscate, Italy facility.
Apr 02, 2015
Pharmaceutical Technology
Process design experimental data and risk assessments are used to predict expected process performance and establish process performance qualification acceptance criteria.
Mar 30, 2015
PTSM: Pharmaceutical Technology Sourcing and Management
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.
Mar 02, 2015
Pharmaceutical Technology
Cleanability is crucial when choosing components for GMP manufacturing areas.
Feb 24, 2015
Pharmaceutical Technology
By Pharmaceutical Technology Editors
The company voluntarily recalls product due to FDA observations of potential sterility problems.