Quality Systems

Jul 21, 2017
By BioPharm International Editors
Updated ISPE guidance offers risk assessment guidance to avoid cross contamination in multiproduct pharmaceutical manufacturing facilities.
Jul 21, 2017
By BioPharm International Editors
The agency will lead an international team to create a Supply Chain Security Toolkit of resources to educate the pharmaceutical and healthcare industries on supply chain vulnerabilities.
Jul 12, 2017
By BioPharm International Editors
One day after Ocular Therapeutix sent FDA a detailed response highlighting manufacturing improvements, FDA rejected its application for Dextenza, a new drug designed to alleviate post-operative eye pain.
Jul 10, 2017
By BioPharm International Editors
FDA sent a warning letter to Shandong Analysis and Test Center for CGMP violations including data integrity issues and insufficient testing procedures.
Jul 01, 2017
BioPharm International
Short tandem repeat profiling is the most validated method to confirm cell line identity and avoid misidentified or cross-contaminated cell lines.
Jul 01, 2017
BioPharm International
Electronic systems can remove opportunities for individuals to make mistakes or to manipulate the data.
Jul 01, 2017
BioPharm International
Continuous processing of 100 g of monoclonal antibody in 24 hours has been demonstrated using lab-scale equipment.
Jul 01, 2017
BioPharm International
CDER’s Janet Woodcock endorses modern drug manufacturing to ensure access to safe and reliable medicines.
Jul 01, 2017
BioPharm International
Single-use bags containing toxic or hazardous materials required special handling.
Jul 01, 2017
BioPharm International
While the measurement of the toxicity of leachables is not always a required parameter, the information collected during these studies could inform future bioprocessing runs.
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