Quality Control/Quality Assurance

Sep 17, 2018
By BioPharm International Editors
FDA sent a warning letter to Lernapharm (Loris) Inc. detailing the company’s lack of procedures to prevent microbiological contamination.
Sep 14, 2018
By BioPharm International Editors
FDA testing has found an additional impurity, N-Nitrosodiethylamine, in the API valsartan.
Sep 12, 2018
FDA is revising its inspection process and seeks harmonization of standards for US and foreign regulatory oversight to ensure the safety of medicines.
Sep 10, 2018
By BioPharm International Editors
Gore’s new flexible freeze containers are designed to protect high-value drug substances from container breakage or leakage.
Sep 10, 2018
FDA, innovator companies, and biosimilar developers maneuver over exclusivity, naming, interchangeability, and more.
Sep 01, 2018
BioPharm International
The US Pharmacopeial Convention (USP) is developing a new chapter for rapid sterility testing of short-life products based on the recommendations of a panel of experts and stakeholders.
Sep 01, 2018
BioPharm International
This study was successful in establishing a reliable and effective method for evaluating cleaning processes based on risk.
Sep 01, 2018
BioPharm International
Viral vaccines and viral vectors used in biotherapeutic applications carry the risk of microbial contamination, which must be addressed.
Sep 01, 2018
BioPharm International
Trace elements in raw materials may impact the quality and safety of the finished biologic product, according to industry experts.
Sep 01, 2018
BioPharm International
Detailed process descriptions and robust documentation aid in compliance as well as training, says Siegfried Schmitt, principal consultant at PAREXEL.
native1_300x100
lorem ipsum