In this video:
Session: Prabhaharan Sankaran, Technical Account Specialist, West Pharmaceutical Services
Topic: Application of Quality By Design in Development of NovaPure® Closures
Key Highlights:
● Pharmaceutical Quality by Design (QbD) is a systemic approach which is methodical and based on science based process. It focusses on process robustness-understanding and controlling variability
● FDA encourages risk-based approaches and adoption of QbD principle during the drug development and manufacturing
● Application of QbD in product development includes mitigating overall risk, low particulates level, high knowledge transparency and complete design history file
● QbD in product development also helps in low product to product variation, optimized functional profile and high visual quality.
● NovaPure® Closures by West Pharma are based on tested and proven stopper design