Regulatory/GMP Compliance

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.
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 12, 2017
By BioPharm International Editors
The agency sent a warning letter to Vista Pharmaceuticals Limited for CGMP failures related to equipment cleaning and process control.
Jul 01, 2017
BioPharm International
Optimize practices and meet requirements using electronic data integrity systems.  
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
This article presents a general strategy for authorship of deviation investigations, with primary focus on regulatory inspection success.
Jun 06, 2017
By BioPharm International Editors
Yusef Manufacturing Laboratories, LLC received an FDA warning letter citing CGMP violations at its Clearfield, UT facility.
Jun 01, 2017
BioPharm International
How statistical methods and novel indices can be used to monitor and benchmark variability, to guide continuous improvement programs.
Jun 01, 2017
BioPharm International
As more companies decouple drug substance from finished drug manufacturing operations, an integrated approach can ensure safe, reliable logistics for frozen storage and shipping.
native1_300x100
lorem ipsum