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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.
January 28, 2019
The investigation into the root cause of the NDMA impurity found in API is still ongoing, but the agency believes the impurities may be caused by specific chemicals and reaction conditions in manufacturing processes.
The guidance describes how to develop a REMS Assessment Plan, discusses the impact of REMS on patient access to drugs, and gives recommendations on reporting REMS findings to FDA.
January 25, 2019
The company is voluntarily recalling six lots of Losartan potassium and hydrochlorothiazide tablets, USP because of the impurity, NDEA.
Full commercial launch of the drug is underway in the United States, with Europe to follow.
January 16, 2019
The Qualit-e Cloud web portal allows for secure uploading and sharing of quality documents for raw materials.
January 15, 2019
Industry investment and regulatory support combined to move many important new medicines to market.
January 11, 2019
The plan details five goals to guide the development of Sentinel, a national electronic system for medical product safety surveillance established as part of the FDA Amendments Act of 2007, over the next five years.
January 08, 2019
Sun Pharmaceutical Industries, Inc. is recalling lots of Vecuronium Bromide for Injection because of glass particulates.
January 07, 2019
The company is recalling 5 lots of Ceftriaxone for Injection, USP, 250mg; 10 lots of Ceftriaxone for Injection, USP, 500mg; 24 lots of Ceftriaxone for Injection, USP, 1g; and 3 lots of Ceftriaxone for Injection, USP 2g because of the presence of particulate matter in reconstituted vials.
The Steritest NEO device from MilliporeSigma provides safer pharmaceutical product testing through additional features.