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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.
June 28, 2018
The new resin used a combination of “jetting” technology and a high-performance Protein A ligand.
June 27, 2018
FDA sent a warning letter to Henan Lihua Pharmaceutical Co. Ltd. after inspectors found the company failed to ensure the accuracy of its data.
June 25, 2018
The company’s next-generation ultraperformance liquid chromatography platform is designed to meet the evolving laboratory requirements for chromatographic performance.
June 22, 2018
The agency published guidance about requests for Prescription Drug User Fee Act waivers, refunds, and reductions in user fees.
The approval is intended to increase patient access to treatment for opioid addiction.
June 21, 2018
The contract development and manufacturing company has received an additional approval from Health Canada to manufacture monoclonal antibody drug substance at its first plant in Icheon, South Korea.
June 20, 2018
Legislators have requested that FDA do more to prevent drug shortages.
June 08, 2018
Regulatory authorities have published draft guidance on strategies to facilitate pharmaceutical lifecycle management.
June 07, 2018
The agency is encouraging team-based reviews and streamlined processes that will make the oversight process more efficient and consistent.
The company will provide the first FlexFactory manufacturing platform for cell therapy manufacturing.