Quality Systems

Oct 02, 2018
Pharmaceutical Technology
A European task force outlines its upcoming efforts to combat drug shortages.
Oct 02, 2018
Pharmaceutical Technology
Susan Schniepp, executive vice-president of Post-Approval Pharma and Distinguished Fellow, Regulatory Compliance Associates, takes a look at the regulations around data integrity and how they relate to the concept of quality culture.
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.
Oct 01, 2018
FDA is joining with other federal health agencies and the biomedical research community to advance the science, regulatory policies, and reimbursement strategies to support innovation in antimicrobials.
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 has entered into an agreement with the National Academies of Science, Engineering & Medicine and has expanded agreements with the University of Maryland and Johns Hopkins University Centers for Regulatory Science and Innovation to conduct research on the compounding of drugs.
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 27, 2018
CDER director plans to start implementation of new review practices by the end of 2018.
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.
native1_300x100
lorem ipsum