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.
Guidance on Quality Culture Standards
June 3rd 2025Matt Cushing, VP of Quality and Science, Nelson Labs, and Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, a Nelson Labs Company, discuss PDA/ANSI Standard 06-2025: Assessment of Quality Culture Guidance Documents, Models, and Tools, which was published in February 2025.
Ushering in Industry 4.0 with the IDMO Model to Solve the CGT Manufacturing Bottleneck
May 28th 2025Global scale-up requires developing replicable processes that work the same no matter where they are performed. This can be accomplished with smart factories that utilize fully automated manufacturing platforms.
