GMPs

Jul 20, 2015
By Pharmaceutical Technology Editors
Baxter has initiated a voluntary recall of two lots of IV solutions due to the potential presence of particulate matter.
Jul 02, 2015
Pharmaceutical Technology
Heightened regulatory scrutiny of data integrity highlights the need for comprehensive procedural reviews and strategies for managing mission-critical information.
Jul 02, 2015
Pharmaceutical Technology
Siegfried Schmitt, principal consultant, PAREXEL, discusses how to handle internal audit reports during inspections.
Jul 01, 2015
Pharmaceutical Technology
An ISPE guidance document, four years in the making, brings risk-based thinking, statistics, and Lean Six Sigma to cleaning validation.
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.