What can you do to ensure control over outsourced processes?

Most medical device companies will find themselves at some time having to consider outsourcing, whether it is the entire manufacturing or a specific process for which the company does not have the expertise or resources. Developing a comprehensive quality agreement with the subcontractor is critical to a successful relationship, and provides a medical device company with confidence that the subcontractor can meet their requirements. The quality agreement provides a standard to which the medical device company can evaluate the subcontractor’s performance and demonstrate control over their outsourced processes under their Quality Management System.

What information should be included in a subcontractor quality agreement?

The quality agreement should clearly define the responsibilities of both parties, and performance requirements and expectations. Depending on the scope of the agreement and nature of the activities involved, items included in the quality agreement can range from specifying a date of delivery to defining quality and/or industry standards and/or regulations applicable to services provided by a subcontractor. Requirements for performance should be clearly defined to prevent any misinterpretation, be specific, measurable and periodically subject to an audit.

Jerry Holatko, H.B.Sc., Chem.
Senior Director, Consultative Services
PharmEng Technology Inc.
Suite 201 3760 – 14th Avenue
Markham, ON L3R 3T7
jerry.h@pharmeng.com
www.pharmeng.com

Do you have questions on Regulatory issues? Send your questions to Katherine Taverner