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March 16, 2021
Many biologic drug manufacturers encounter similiar challenges; precompetitive collaboration can help resolve these issues. Representatives of the IQ Consortium’s Biologics CMC Leadership Group describe efforts to address the safe handling of biologic drugs in closed-system transfer devices in healthcare settings and the need for phase-appropriate specifications.
Extrapolating data from adult clinical trials to a pediatric population is a proven method to avoid unnecessary pediatric clinical trials. Representatives of the Pediatric Working Group of the IQ Consortium share case studies that demonstrate how adult clinical trial data can be used to support the dose selection and regimen—or waive the need for a placebo control arm—for pediatric studies.
Maintaining a quality culture across the diverse functions in a bio/pharmaceutical company is difficult. Representatives of the Quality Coordinating Committee of IQ Consortium report on collaborative efforts to address data integrity and the modernization of FDA’s good laboratory practice regulations.
A plant inspection backlog caused by COVID-19 restrictions threatens innovation and public health. Now pressured to step up on-site inspections, will FDA embrace new methods?
March 03, 2021
The need for real-time monitoring and control has spurred the development of new analytical tools.
March 02, 2021
Auditing distribution suppliers provides understanding and documentation of the services performed, says Siegfried Schmitt, vice president, Technical at Parexel.
February 10, 2021
Pharma companies find ways to maintain quality standards, despite pandemic-related restrictions.
FDA sent a warning letter to Allay Pharmaceuticals for inadequate written procedures; inadequate out-of-specification testing; inadequate stability testing; and inadequate quality control oversight.
The importance of characterizing excipients, supply chain security, and the role of novel excipients are explored.
February 04, 2021
The company recently installed a fully validated visual inspection system that uses artificial intelligence in an automated inspection machine.