GMPs

Jun 19, 2015
By Pharmaceutical Technology Editors
NIH provides an interim corrective action plan to correct deficiencies found in its Clinical Center Pharmaceutical Development Section.
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.
Jun 05, 2015
Drug quality issues have forced the National Institutes of Health to shutter its in-house facility for producing clinical supplies for certain clinical trials.
Jun 05, 2015
Agency officials visited China to meet with Chinese regulators and industry representatives about keeping the pharma supply chain safe.
Jun 04, 2015
By Pharmaceutical Technology Editors
FDA cites 17 observations including air handling, quality control, and deficient microbial monitoring at NIH’s Clinical Center Pharmaceutical Development Section.
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.