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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.
February 02, 2019
Spectroscopic-based control methods were introduced as equivalent alternative methods, first to a gas chromatographic method to monitor an in-process solvent exchange step and second to a potentiometric titration method to release a process input material for drug substance manufacturing.
Getting to the root of the cause can prevent future problems, says Susan Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.
Policies emphasize the importance of ensuring data integrity in the United States and abroad.
Robotic isolators and single-use technologies are gaining ground, according to aseptic processing consultant Jim Agalloco.
The market for biosimilars in Europe remains consistently robust, with 16 new biosimilars approved in 2018.
February 01, 2019
A look at some best practices to ensure that quality control is maintained in the client–vendor relationship.
Only careful planning can prevent problems that stem from differences between a sponsor’s and a CDMO’s equipment, practices, and culture. This article highlights best practices and case studies.
January 31, 2019
The company is recalling three additional lots of Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 mL because of a higher concentration of ibuprofen.
In a statement, FDA Commissioner Scott Gottlieb announced the agency’s plans to publish guidance to promote the development of complex generic drugs.
FDA staffers will be hard-pressed to process and review the wave of new drug application submissions in pre-established timeframes for action.