Outsourcing

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

Articles

Recent draft guidance from FDA on contract manufacturing and quality agreements highlights the importance of such agreements and define the roles and responsibilities of each party to be in keeping with quality risk-management principles.

Defining Quality Agreements

The author discusses how a CDMO helps in gaining process understanding and in developing robust, high-quality products and processes.

Quality by Design: A Contract Organization's Perspective

Susan J. Schniepp is a fellow at Regulatory Compliance Associates, Inc. and a member of Pharmaceutical Technology's Editorial Advisory Board.

The author describes an equation that can be used to define the Quality relationship between a contract manufacturing organization and a client, including how to factor in both party's needs and regulatory commitments.

Contract Services, Regulatory Consulting