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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.
April 22, 2022
FDA is requesting comment on draft document “Pharmaceutical Quality/Chemistry Manufacturing and Controls Data Exchange.”
FDA has approved commercial production at Kite’s new CAR T-cell therapy manufacturing facility in Frederick, Maryland.
April 20, 2022
New guidance from FDA and legislation from Congress promote clinical trial diversity.
April 15, 2022
Mylan Pharmaceuticals is issuing a voluntary recall of one batch of insulin glargine injection due to the potential for a missing label in the batch.
April 13, 2022
Swissmedic grants conditional marketing authorization for Novavax COVID-19 vaccine for individuals aged 18 years or older in Switzerland.
Exhibitors display primary packaging, secondary packaging, and machine innovations at this year’s INTERPHEX.
April 12, 2022
FDA is reviving efforts to establish a Quality Management Maturity program.
Pharmaceutical Technology asked Jeff Elton, PhD, CEO of ConcertAI, about the role technology plays in performing CAPAs.
Orchard Therapeutics announces reimbursement agreement, which will make Libmeldy available for all eligible MLD patients in Italy.
Dupixent has been approved by the EC for children aged 6 to 11 years with severe asthma with type 2 inflammation.