Developing World Class Quality Monitoring and Controls Systems

The pharmaceutical industry continually strives for the utmost quality in its products while ensuring patient safety. Manufacturers demonstrate quality control through a robust quality risk program, which can also serve as a proactive method for identifying and controlling potential risks throughout the product lifecycle. A quality system at its most practical is a roadmap to ensure that a company’s processes, SOPs and sub-systems act in coordination so that issues are appropriately identified, assessed, investigated and escalated for management information and remedial action. FDA’s CDRH Quality System and Quality System Inspection Management Program, as well as ICH Q10 Pharmaceutical Quality System guidelines, have become an industry norm for effective pharmaceutical quality systems, but can be challenging to implement on a real world scale. A properly designed and executed quality system will move products through the development process to commercialization more quickly than any other methodology. The fact that patient safety, product quality and compliance are integral to the quality system approach can also ensure rapid regulatory approval.