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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 28, 2017
FDA sent a warning letter to Shandong Vianor Biotech Co., Ltd. that claimed the company failed to follow proper data integrity and quality control procedures.
The agency will require training for healthcare providers who prescribe immediate-release opioids.
September 27, 2017
The FDA commissioner made a statement about the agency’s efforts to ensure patient access to safe compounded medicines.
September 26, 2017
Staff survey on the relocation of EMA indicates that the future of public health in Europe is at stake.
September 25, 2017
Pharmaceutical companies should prepare for the impact of recalls to minimize risk to consumers and the company.
Biopharmaceutical companies developing new competitive biotech therapies have pressed hard for clarity on the testing and data required by FDA to gain market approval of biosimilars that can be filled by a pharmacist without prescriber preapproval.
FDA participated in a global operation to combat the sale and distribution of unapproved and illegal drugs.
September 21, 2017
The agency sent out 13 warning letters on Sept. 19, 2017 to companies selling drug products online.
September 19, 2017
Validation and batch testing failures were among the violations found by the FDA at the company’s Jiangsu facility.
September 15, 2017
Continued industry investment in advanced biologics will raise further regulatory challenges and require innovative manufacturing systems.