A Risk-Based Approach To Validation Studies For Sterilizing-Grade Filtration And Single-Use Systems

Ensuring drug quality cannot rely solely on finished-product testing. Process validation is critical to provide scientific evidence that a process consistently and reproducibly produces a safe and effective drug.

Quality by Design (QbD) was introduced by the US Food and Drug Administration (FDA) as part of its initiative, "Pharmaceutical CGMPS for the 21st Century – A Risk-Based Approach." It was later reinforced through the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines, the EU Guidelines Good Manufacturing Practice (GMP) for Medicinal Products for Human and Veterinary Use, Annex 1: Manufacture of Sterile Medicinal Products), and the Chinese Guidelines for the Technology and Application of Sterile Filtration. These frameworks emphasize building quality into pharmaceutical development right from the start.

A central aspect of QbD and Quality Risk Management (QRM) is risk mitigation, and manufacturers are increasingly looking for ways to integrate quality into each stage of production to reduce risks. In aseptic processing, this involves a comprehensive understanding of the design space for sterile filtration and single-use systems.

A method to address risk related to product quality is by implementing a Question-based Review approach. Continue reading to learn more about this approach and its advantages.