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It is important to understand the differences between risk-based decision making and other decision making in a pharmaceutical quality system.
Validating computerized systems is required to demonstrate adherence to data integrity, says Susan J. Schniepp, distinguished fellow at Nelson Laboratories, LLC.
Quality-by-design risk assessment workflows can be laborious and have limited capacity to connect with vast volumes of prior knowledge generated by organizations. ecosystem.
December 02, 2018
Three hypothetical analytical target profiles (ATPs) are provided, reflecting the current thinking of the the European Federation of Pharmaceutical Industries and Associations Analytical Lifecycle Management Team.
GMP non-compliance can spill over and impact patient access to life-saving medications.
November 29, 2018
A new, high-throughput microplate reader cuts down on screening time and works faster than standard ultra-high-performance liquid chromatography processes.
The partnership, co-funded by Enterprise Ireland, will develop technologies for monitoring the quality of biopharma processes.
Despite ongoing efforts to address the problem, FDA now sees a rise in active shortages and in the duration of supply problems.
November 27, 2018
The agency has approved two new chemical entities, Daurismo (glasdegib) from Pfizer, and Vitrakvi (larotrectinib) from Loxo Oncology, for treating cancers.
FDA has issued a warning letter to Mylan citing GMP violations of finished pharmaceutical products manufactured at the company’s Morgantown, WV, facility.
November 16, 2018
The positive opinions included the first oral-only tablet for the treatment of human African trypanosomiasis.
After a review of serious side effects, the agency decided to suspend marketing authorizations for quinolone and fluoroquinolone antibiotics and restrict use of remaining fluoroquinolone antibiotics.
Moving forward with gene therapy development requires a “quantum leap” in manufacturing capabilities.