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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 20, 2022
FDA has announced that bebtelovimab is not currently authorized for emergency use in any region of the US.
This article focuses on drawing parallels between ICH Q14/Q2(R2), United States Pharmacopeia (USP) , and International Organization for Standardization/International Electrotechnical Commission (ISO/IEC) 17025:2017.
December 16, 2022
Some manufacturers are developing smaller, more mobile drug manufacturing processes for point-of-use patient care.
December 08, 2022
FDA struggles to track shortages caused by a rise in demand.
The most safe and effective therapies demand the highest data quality.
December 07, 2022
Ferring Pharmaceuticals’ Rebyota was approved for the prevention of recurrence of Clostridioides difficile infection.
December 03, 2022
Overall industry growth conceals growing numbers of smaller, faster-paced, adaptable corporate structures.
QMM is an evolutionary advancement in FDA’s quality management maturity initiative that provides industry with a viable methodology to assess and improve manufacturing quality and supply chain reliability.
December 02, 2022
The European Human Medicines Directive and Regulation is due to be updated by the end of 2022, but what changes are on the cards?
Health crises, political tension, and budget concerns were major challenges.