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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.
June 16, 2016
The OMCL Network met increasing market demand for testing quality of medicinal products, blood-derived medicinal products, and vaccines in Europe.
The agency provides quality, development, manufacturing, and labeling recommendations.
June 15, 2016
Computerized systems can solve some of the data integrity problems with conventional paper-based systems.
The agency cited a Memphis drug compounder for misbranded drugs and a lack of appropriate sterile processes.
The issues cites the Taiwan facility with violations of current good manufacturing practice regulations.
FDA cited a Las Vegas compounding pharmacy for sterility violations.
FDA sent a warning letter to The Compounding Pharmacy of America for deficiencies in sterile manufacturing.
June 13, 2016
The agency published guidance on the nonclinical evaluation of osteoporosis treatments.
FDA approved Vaxchora intended for travelers who are at risk for the disease.
June 10, 2016
Mandatory use of the periodic safety update report repository becomes mandatory on June 13.