Regulatory/GMP Compliance

Aug 21, 2017
By BioPharm International Editors
The directors of FDA’s Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, and Center for Devices and Radiological Health praised Congress’ reauthorization of user fee programs.
Aug 18, 2017
By BioPharm International Editors
The agency published guidance on identifying trading partners under DSCSA.
Aug 14, 2017
By BioPharm International Editors
The agency sent a warning letter to Cellex-C International regarding GMP violations found at the company’s Toronto facility.
Aug 10, 2017
Efforts to establish an international system for identifying and tracing drugs through the global supply chain are moving forward.
Aug 08, 2017
The review of batch records creates a story of the materials, manufacturing, and packaging involved in the production of bio/pharmaceuticals, according to Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.
Aug 01, 2017
BioPharm International
Managing and prioritizing risk is essential to ensuring raw material quality. USP is developing new guidelines to make the work easier.
Aug 01, 2017
BioPharm International
Industry experts weigh in on best practices, challenges, and mutual recognition of cleaning validation standards.
Jul 25, 2017
By BioPharm International Editors
FDA sent a warning letter to Sage Products, Inc. regarding CGMP failures involving test methods, sampling, and sterilization procedures.
Jul 25, 2017
By BioPharm International Editors
Eli Lilly and Incyte face a roughly 18-month application delay for rheumatoid arthritis drug, baricitinib, in the US with a request from FDA for additional clinical data.
Jul 18, 2017
By BioPharm International Editors
The agency cited the Italian company for aseptic processing failures.
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