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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 02, 2016
Early planning for the integration of clean-in-place systems for equipment cleaning is key.
FDA approved the Raplixa, the first spray-dried fibrin sealant, in May 2015 to help control bleeding in adults during surgery.
China and India are also increasing inspections and becoming more exigent about data integrity and cGMPs.
Data integrity and cGMP issues demand closer scrutiny of suppliers. Bribery and corruption may become the next supply chain flashpoint.
The impact of pharmaceutical manufacturing on the environment has triggered demands for tighter environmental controls in EU and national legislations.
June 30, 2016
The drug received breakthrough therapy and orphan drug designation as a monotherapy for the treatment of chronic graft-versus-host-disease.
June 28, 2016
The monoclonal antibody for the treatment of two forms of multiple sclerosis has a target action date of December 28, 2016.
June 27, 2016
ICH detailed the highlights of the council’s June 2016 meeting.
June 24, 2016
The agency is following up on a February 2016 inspection of the facility that found GMP violations.
The agency recommends Zalmoxis, a new cell-based therapy to support stem cell transplantation in patients with high-risk blood cancer.