The biopharmaceutical industry is c

The biopharmaceutical industry is continuously undergoing organizational changes intended to better support the healthcare industries while maintaining quality and reducing cost. This article will illustrate how manufacturers can add value to their operations by using a quality validation risk management approach for the development of sampling plans. Establishing a quality validation risk management approach for all pharmaceutical processes would increase the probability of successful outcomes for both the companies producing the products — by helping to meet regulatory requirements — while better contributing to the quality of healthcare for patients.