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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.
September 18, 2020
The EMA recommendations include a meningococcal vaccine and the biosimilar Nyvepria.
The agency sent a warning letter to Kalchem International for CGMP violations found at the company’s Lindsay, OK, facility.
September 15, 2020
GenSight Biologics has submitted a marketing authorization application to the European Medicines Agency for Lumevoq.
September 14, 2020
The temporary guidance discusses the resumption of normal manufacturing during the COVID-19 pandemic.
September 11, 2020
In an opinion article, FDA leaders commit to applying “the best science” to approval decisions.
September 09, 2020
PRAC has recommended the marketing authorization of ulipristal acetate for the treatment of uterine fibroids be revoked.
September 08, 2020
Industry leaders insist they will maintain high standards for clinical trials and regulatory submissions for new vaccines and therapeutics to combat COVID-19.
September 03, 2020
Risk-based decision-making is impacting all aspects of manufacturing quality from raw material supply to facility inspections.
September 02, 2020
Despite pharmacovigilance legislation being in place for nearly a decade, many companies are still struggling to fulfill obligations.
Processes, people, and tools are needed to comply with the pharmacopoeia and approved drug product registrations.