GMPs

Aug 02, 2015
Pharmaceutical Technology
By Pharmaceutical Technology Editors
Mitigating risk in the bio/pharmaceutical sector demands a holistic approach.
Aug 02, 2015
Pharmaceutical Technology
Susan Schniepp, distinguished fellow, and Andrew Harrison, chief regulatory affairs officer and general counsel, both of Regulatory Compliance Associates, discuss the requirements for a successful corrective action and preventive action (CAPA) system.
Jul 31, 2015
PTSM: Pharmaceutical Technology Sourcing and Management
By Pharmaceutical Technology Editors
“Rough notes” documentation and data management failures lead to warning letter for Mahendra Chemicals.
Jul 31, 2015
PTSM: Pharmaceutical Technology Sourcing and Management
By Pharmaceutical Technology Editors
Baxter has recalled of one lot of IV solution due to the potential for leaking containers, particulate matter, and missing port.
Jul 28, 2015
PTSM: Pharmaceutical Technology Sourcing and Management
By Pharmaceutical Technology Editors
FDA’s quality metrics draft guidance details the types of data the agency plans to request and the quality metrics it plans to calculate.
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.