Risk Management of the Minimum CMC Regulatory Compliance Continuum

The challenge of control of the biopharmaceutical manufacturing process coupled with the complexity of the resulting biopharmaceutical products create pressure on meeting the CMC regulatory compliance requirements expected by regulatory authorities. Fortunately, the regulatory authorities accept a strategy that embraces a 'minimum CMC regulatory compliance continuum' for biopharmaceuticals (both protein-based and gene therapy-based). In this chapter, it will be discussed how the minimum CMC regulatory compliance continuum can be achieved by applying a strategic risk-based approach toward three interactive components – (1) CMC Regulatory, (2) cGMPs, and (3) the Quality System. A strategic risk-based approach recommended by the regulatory authorities – Quality by Design/Quality Risk Management (QbD/QRM) – will also be examined in detail.