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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.
January 02, 2018
A new algorithm uses a statistical approach to critical process parameter assessment, allowing for faster, more consistent, and less subjective critical process parameter quantification, visualization, and documentation.
December 28, 2017
The biotechnology company has filed for FDA approval of a new plasma manufacturing facility in Covington, GA, to support its immunology franchise.
The recall was initiated due to a product complaint in which white particulate matter, identified as mold, was discovered in a flexible bag from one batch.
December 20, 2017
Implementation of the Packaging Serialization Standard cuts serialization costs, shortens deployment time, and expedites compliance with anticounterfeiting regulations.
New tax legislation may result in savings for biopharma companies.
The company is voluntarily recalling one lot of Pantoprazole Sodium for Injection 40 mg per vial because of glass particles found in a vial.
FDA has approved a new gene therapy for treating patients born with a rare, inherited vision loss.
FDA sent a warning letter to Deserving Health International Corp. after inspectors found CGMP violations including failure to prevent microbiological contamination.
December 19, 2017
Sanofi Genzyme and its partner, Alnylam Pharmaceuticals, have filed a marketing authorization application with EMA for an investigational RNAi therapeutic for treating a genetic-based disease.
EMA recommends suspending the marketing of modified- or prolonged-released products containing paracetamol due to a difficulty in managing overdose.