Quality Systems

May 16, 2018
By BioPharm International Editors
The company is recalling Piperacillin and Tazobactam for Injection, USP 3.375 Gram/Vial And 4.5 Gram/Vial strengths because of concerns of decreased potency due to elevated levels of impurities.
May 08, 2018
By BioPharm International Editors
The company received a complete response letter from FDA in response to the biologics license application for a proposed rituximab biosimilar.
May 07, 2018
By BioPharm International Editors
The data and analytics company reports on the anticipated uptake of Humira (adalimumab)‎‎ biosimilars in the EU once they are launched in 2018.
May 07, 2018
Smaller review divisions will bring experts closer to decision processes and reduce bottlenecks, FDA leaders say.
May 02, 2018
Public health authorities and the biomedical research community are seeking new strategies to address global health threats.
May 01, 2018
BioPharm International
Process understanding and careful assessment of risks are essential in developing viral clearance programs.
May 01, 2018
BioPharm International
The National Institute of Standards and Technology (NIST) has developed Standard Reference Material (SRM) 2082 as a pathlength standard for UV absorbance measurements for use with the new generation of microvolume spectrophotometers and short-pathlength cuvettes.
May 01, 2018
BioPharm International
A validation plan developed to support a process unrelated to bio-pharmaceutical manufacture is applied to biopharmaceutical processes and systems.
May 01, 2018
BioPharm International
FDA’s commissioner addresses opioid abuse, drug costs, and manufacturing quality.
May 01, 2018
BioPharm International
Monetary benefits will outweigh the hassle of batch record harmonization, says Siegfried Schmitt, principal consultant at PAREXEL.
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