US FDA Training Up Inspectorate To Oversee Quality Of Novel Manufacturing Technologies
Agency is hiring contractor to identify gaps in the ability of inspectors, investigators and compliance officers to oversee manufacturing quality in the context of new and emerging technologies – and to identify organizations that could fill the gaps through training.
You may also be interested in...
Agency seeks bids to train biologics field personnel on relevant aspects of mRNA technology such as corralling stray plasmids or nanoparticles as the possibilities for the technology expand in the wake of the Pfizer/BioNTech and Moderna COVID-19 vaccine successes. Review documents suggest the first mRNA vaccine inspections focused on more traditional issues.
Alphabet soup of policy developments includes an answer to subjectivity in risk assessment, the unexpected industry benefit of the FDA’s quality rating plans, and some advice on testing for impurities that could be controlled substances.
CEO reacts to FDA untitled letter in interview, saying Valisure is no subpar GMP lab. Rather, it provides independent drug quality testing for buyers and could be part of a broader solution for steering them toward the highest quality drugs.