Process Validation

Jul 17, 2014
By Pharmaceutical Technology Editors
Baxter investigates root cause of cellulosic fibers and/or plastics in four lots of IV solutions.
Jul 11, 2014
By Pharmaceutical Technology Editors
Baxter Healthcare has initiated a nationwide recall of more than 20,000 containers of a pre-mixed beta blocker due to the presence of particulate matter.
Jul 11, 2014
By Pharmaceutical Technology Editors
Sun Pharma, Forest Pharmaceuticals and West-Ward Pharmaceuticals issue recalls over dissolution issues.
Jul 02, 2014
Pharmaceutical Technology
The authors look at the cleanability of pharmaceutical soils from a variety of materials of construction to determine the relative ease of cleaning and explore potential grouping strategies as part of a comprehensive cleaning validation program.
Jul 01, 2014
By Pharmaceutical Technology Editors
Bristol-Myers Squibb issues a voluntary US recall of Coumadin (warfarin sodium) for injection due to presence of particulate matter.
Jun 26, 2014
By Pharmaceutical Technology Editors
GSK Biologicals receives warning about cGMP compliance issues at its Quebec facility.
Jun 18, 2014
PTSM: Pharmaceutical Technology Sourcing and Management
By Pharmaceutical Technology Editors
FDA inspection found cGMP violations in the Bangalore, India API manufacturing facility.
Jun 18, 2014
PTSM: Pharmaceutical Technology Sourcing and Management
By Pharmaceutical Technology Editors
FDA cites cGMP violations for API manufacturing at a facility in Tianjin, China.
Jun 17, 2014
By Pharmaceutical Technology Editors
ISPE Metrics Pilot Program is designed to demonstrate the feasibility and value of standard quality metrics.
Jun 06, 2014
By Pharmaceutical Technology Editors
Despite GMP deficiencies, EMA reinstates GMP certificate for Ranbaxy's Toansa facility, citing no threat to public health.
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