Quality Systems

Aug 14, 2015
BioPharm International
By BioPharm International Editors
The company is in discussions with Europe’s Adaptive Pathways Group on clinical trials that would evaluate its PLX cells for the treatment of specific diseases.
Aug 12, 2015
FDA determined the celebrity’s endorsement of Duchesnay’s morning-sickness medication Diclegis was misleading.
Aug 11, 2015
By BioPharm International Editors
The agency issues guidance for companies considering registering with FDA as an outsourcing facility.
Aug 07, 2015
European Union regulators said Pfizer must divest its infliximab biosimilar candidate and some sterile injectables for the merger with Hospira to be completely approved.
Aug 03, 2015
By BioPharm International Editors
FDA issues guidance regarding fees for drug compounding outsourcing facilities.
Aug 03, 2015
By BioPharm International Editors
FDA issues draft guidance on dissolution testing for immediate-release solid oral dosage forms.
Aug 01, 2015
BioPharm International
This article discusses cleaning validation of equipment dedicated to the production of a single API.
Aug 01, 2015
BioPharm International
FDA and industry support global framework and collaborations to secure the supply chain.
Aug 01, 2015
BioPharm International
Process maps and risk assessments are among the valuable tools operators can apply to reduce the risk of microbial contamination.
Jul 29, 2015
The broader aim of FDA's metrics initiative is to encourage quality manufacturing operations that will help avoid drug shortages.
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