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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 07, 2016
Regulatory agencies meet to discuss approaches to the development of antibacterial agents.
September 02, 2016
Siegfried Schmitt, principal consultant, PAREXEL International, discusses how to find the root cause of the problem.
Industry experts discuss recent trends in modular manufacturing.
Manufacturers and regulatory authorities seek coordinated lifecycle management policies.
Companies may potentially accelerate the approval of generic drugs by avoiding deficiencies in ANDA submissions.
The media blitz surrounding drug shortages has stopped, but critical medications that have no substitutes remain in short supply. Can new approaches turn this situation around?
Visual inspection of parenteral vials is the first step in a root cause investigation.
Swab recovery parameters are reviewed in detail to define best practices and highlight common mistakes to assure successful recovery studies using a risk-based approach.
The authors of "Common Deficiencies in ANDAs for Dermatologic Drug Products" provide some examples of commonly cited deficiencies cited by FDA.
September 01, 2016
Sound process understanding and having effective controls in place are crucial in ensuring that consistent product quality is obtained during API manufacturing.