Quality Assurance/Quality Control

Oct 02, 2018
Pharmaceutical Technology
Experts blame the recalls, not on cGMP failures, but on inadequate risk assessment of processes that can generate toxic impurities.
Sep 28, 2018
By Pharmaceutical Technology Editors
The agency sent a warning letter to the Indian company after an inspection found CGMP violations that included a lack of written procedures and analytical testing.
Sep 28, 2018
By Pharmaceutical Technology Editors
This pharma insight briefing from Agilent Technologies will cover the application of Raman and infrared spectroscopy for pharmaceutical quality control (QC).
Sep 27, 2018
By Pharmaceutical Technology Editors
The agency announced that differences in strength expression on product labels of compounders and conventional manufacturers may lead to dosing errors.
Sep 25, 2018
By Pharmaceutical Technology Editors
Cell-line quality has a significant impact on biologic drug quality; learn more about this and other upstream challenges at the new bioLIVE launching this year adjacent to CPhI Worldwide 2018.
Sep 17, 2018
By Pharmaceutical Technology 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 Pharmaceutical Technology Editors
FDA testing has found an additional impurity, N-Nitrosodiethylamine, in the API valsartan.
Sep 12, 2018
Pharmaceutical Technology
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 Pharmaceutical Technology 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.
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