QRM Tools for Contract Biomanufacturing
Quality-risk management tools can assist biopharma companies in mitigating risks when outsourcing crucial elements of the drug-development process.
For decision making and overall program risk reduction, a quality-risk-management (QRM) program is an effective means for biotech companies to mitigate the risks associated with outsourcing crucial elements of the drug-development lifecycle. Risks only get larger when activities typically performed internally during the development process are outsourced to a contract service provider.
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BioPharm International’s 2015 Outsourcing Resources eBook.
Drug Shortages and Complying with FDA’s 21 CFR 211.110 Guidance
April 2nd 2025Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Rona LeBlanc-Rivera, PhD, principal consultant, Regulatory Affairs at Regulatory Compliance Associates, answer some questions about FDA’s January 2025 21 CFR 211.110 guidance document.
AES Clean Technology Launches Next-Generation OSM Utility Solution for Cleanrooms at INTERPHEX 2025
April 2nd 2025Officially launched at INTERPHEX 2025, the Omni ASCENT is a next-generation off-site manufactured vertical utility solution that offers optimized cleanroom flexibility and efficiency.
