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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.
February 01, 2018
Federal agencies have partnered to develop a roadmap that offers a new framework for the safety testing of drugs and chemicals without the use of animals.
FDA Commissioner Scott Gottlieb says FDA is committed to meet the challenges faced by the saline shortage during an aggressive flu season.
Chemical engineers and chemists each bring unique skills to API process development and optimization. Success depends on their close collaboration, at both sponsor and CDMO facilities.
CRLs put the brakes on drug development and damage corporate reputation and stock prices. Upfront investment and better sponsor oversight are ways to prevent them.
January 31, 2018
FDA and industry weigh broader use of prior knowledge in biotechnology testing and production.
January 26, 2018
The Fluent Gx Automation Workstation from Tecan is suited for a variety of clinical and regulated laboratory applications.
January 24, 2018
The revised Annex 1 on sterile manufacturing includes incorrect and ambiguous statements that must be fixed before implementation.
The agencies sent warning letters to several companies that the agencies say are illegally marketing unapproved products to treat opioid addiction and withdrawal.
January 23, 2018
The latest continuing resolution funds the government for three weeks.
The FDA center released its list of planned guidance documents for the rest of the year.