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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 02, 2018
Quality by design highlights product and process understanding and control, integrating quality risk management, and is also considered a quality system for managing a product’s lifecycle.
June 01, 2018
The new kit is expected to detect a broad spectrum of pyrogens while offering high reproducibility and sensitivity as well as eliminating the need for live animal testing.
The company’s new UV-1900 UV-VIS spectrophotometer incorporates features that improve usability, regulatory compliance, and performance.
May 31, 2018
Ingenza, in partnership with the University of Dundee and Drochaid Research Services, will work on a project to recycle CO2 emissions from bioprocessing plants to serve as feedstock and energy inputs.
The agency published two guidance documents to address brand drug makers’ use of REMS to block generic-drug development.
May 30, 2018
The new draft guidance addresses the premarketing assessment of a drug’s effect on blood pressure.
FDA sent a warning letter to Jilin Shulan Synthetic Pharmaceutical Co., Ltd. after an inspection found CGMP violations including a lack of data integrity.
May 29, 2018
This marks the third FDA approval for the company’s second biomanufacturing plant in Incheon, Korea.
The European Commission has approved Zessly (infliximab), a biosimilar to Johnson & Johnson’s blockbuster Remicade (infliximab).
May 23, 2018
Right-to-Try bill sent to White House for President’s signature after passage by Congress.