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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.
July 29, 2019
Bayer is voluntarily recalling two lots of Kogenate FS antihemophilic factor (recombinant) 2000 IU vials because they contain the incorrect product.
July 26, 2019
EMA has issued a recommendation that the multiple sclerosis drug, Gilenya (fingolimod), not be used in women who are pregnant.
July 17, 2019
MHRA has launched a consultation to gain a greater understanding of the potential application of AQbD in pharmacopoeial standards and the future of medicines standards.
The US Pharmacopeial Convention is partnering with the American Association of Colleges of Pharmacy to provide students with free access to quality standards.
Altaire is voluntarily recalling ophthalmic products because of concerns regarding quality assurance controls in the manufacturing facility.
FDA sent a warning letter to Ecometics, Inc. after the agency found CGMP violations at the company’s Norwalk facility.
The draft guidance describes how content should be organized in electronic submissions for all submission types under section 745A(a) of the FD&C Act.
July 12, 2019
Slovakia becomes the final European Union country to be recognized by FDA, and the mutual recognition agreement for inspections of manufacturing sites between the US and the EU is now fully implemented.
July 11, 2019
The new guidance offers information for new drug application and biologics license application sponsors regarding population pharmacokinetic analysis.
July 10, 2019
The FDA guidance defines changes to approved risk evaluation and mitigation strategies and clarifies submission guidelines.