QRM Tools for Contract Biomanufacturing

June 15, 2015
Bikash Chatterjee

Bikash Chatterjee is president and chief technology officer at Pharmatech Associates

BioPharm International, BioPharm International-06-15-2015, Volume 2015 eBook, Issue 1

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.