Xavier Initiative Aims to Develop Good Supply Practices
Executive Summary
When Xavier University convened a group of pharmaceutical manufacturing supply chain quality experts to find out why they have such problems with their suppliers, they discovered a surprising root cause: their own companies. Now they’re identifying steps the industry can take to improve the situation.
You may also be interested in...
User Fee Bill Puts Industry, FDA to Work on Supply Chain Risks
The user fee legislation Congress approved June 26 makes quality risk management a GMP requirement, further pressuring pharmaceutical manufacturers to make sure they are protecting their global supply chains. The bill directs FDA to inspect based on risk rather than time or location, and to rely on trusted foreign inspectorates, while adding new user fees for generic drugs that will boost funding for further expansion of the agency’s inspectorate.
‘Shadow’ Factory Challenges Continue For US FDA
Agency wants more information about API suppliers as it winds up case against KV Tech for hidden use of Dr. Reddy’s plant and seeks to find disappearing manufacturer of contaminated OTC eye drops.
US FDA, USP Raise Questions About Valisure’s Assertions Of Benzoyl Peroxide’s Benzene Risks
The US drug regulatory authority and standard-setting organization are evaluating the drug-screening venture’s findings regarding stability and potential carcinogenic risks associated with the widely used acne treatment, which includes Rx formulations.