Process Validation

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.
May 19, 2014
By Pharmaceutical Technology Editors
Hospira has recalled one lot of labetalol hydrochloride injection, USP, due to visible particulates.
Feb 25, 2014
PTSM: Pharmaceutical Technology Sourcing and Management
By Pharmaceutical Technology Editors
Daiichi Sankyo announced suspension of API shipments from Ranbaxy's Toansa and Dewas plants; issues apology to stakeholders.
Jan 24, 2014
By Pharmaceutical Technology Editors
FDA adds Ranbaxy's Toansa, India facility to existing consent decree, prohibiting distribution of APIs from that location
Jan 22, 2014
By Pharmaceutical Technology Editors
Online portal accepts nominations for FDA advisory committee membership.
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