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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 19, 2016
The guidance discusses the implementation of CMC postapproval changes through a comparability protocol.
PRAC said it has plans to review both canagliflozin and several direct-acting antivirals, after new study data showed potential risks associated with the drugs.
April 18, 2016
The agency published guidance on data integrity as it is relates to CGMP compliance.
April 15, 2016
FDA explains the rewards that may be associated with switching from batch to continuous manufacturing.
The agency published draft guidance on prescription requirements, hospital pharmacies, and outsourcing facilities for compounders.
FDA’s breakthrough drug initiative is more popular and successful than ever.
April 14, 2016
The company has recalled one lot of 50% magnesium sulfate injection, USP due to particulates.
The agencies detail the results of their three-year collaboration.
The Office of Generic Drugs highlights the agency’s work to advance generic drugs.
April 12, 2016
The agency issues safety guidance to minimize medication errors relating to product design and container closure design.