We discussed how and why target product profiles are established for biopharmaceutical products, as well as how the design control process impacts the high-risk medical device design process.

We discussed how and why target product profiles are established for biopharmaceutical products, as well as how the design control process impacts the high-risk medical device design process.  As we are taking a closer look at how quality assurance is involved in ensuring that not only biomedical product design is controlled, but also how manufacturing & supply chain management can dramatically impact the safety and efficacy of these products, even when designed properly for their intended use(s).  From what you have learned so far, and from your perspective what happens when the manufacturing arm of the organization does not create products according to their intended design?  What are the consequences from safety and efficacy perspectives?  Who should be responsible for ensuring that product specifications meet pre-defined acceptance criteria?