Quality Assurance And Your CDMO

By Chantale G. Robles

It’s no longer just a cost of doing business; your outsourced manufacturing partner’s approach to QA can save you money and reduce time to market.

Like you and every other developer and manufacturer in our space, Grifols is held accountable to quality standards by a host of regulators with indisputable requirements and expectations. The scrutiny is constant and the standards high, but none of this is necessarily unique to Grifols. Compliance with industry guidance and client requirements is a fact of doing business in biopharma. (See sidebar: A Sampling Of Quality Standards And Requirements.)

There is an inherent advantage in having experience from different angles (both as a customer receiving services and as a CDMO providing services), multiple product platforms (diagnostics, reagents, instruments, therapeutics), and expertise in multiple global manufacturing and quality locations. These perspectives have contributed to the development of QA processes at Grifols that provide ample room for efficiency-enabling flexibility, differentiation, and cost savings.