09 02 21 -- EMA Publishes New Guidelines
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08 26 21 -- B Cepacian: A Case Study On Objectionableness In Drug Manufacturing
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07 29 21 -- FDA s New Guidance On CMC Changes To An Approved Application
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01.26.21 Top 10 Most-Cited MHRA GMP Inspection Deficiencies
Continuing our Cell & Gene series,
Business of Biotech features Dr. Bobby Gaspar, Orchard Therapeutics CEO, speaking on the challenges his company faces in the production of hematopoietic stem cells to treat neurometabolic disorders, primary immune deficiencies, and blood disorders. Listen now and subscribe so you never miss an episode.
Featured Editorial
By Barbara Unger, Unger Consulting Inc.
In Part 1 of this two-part article, we evaluated the U.K. Medicines and Healthcare products Regulatory Agency’s GMP inspection data for 2019 and addressed the critical and major deficiencies and the annexes and chapters with which they are associated. In this part, we take the 10 chapters and annexes with the highest numbers of deficiencies and do a deeper dive into the specifics of each.