Article: Analytical Quality by Design (AQBD) approach to support analytics optimisation strategy
Analytical procedures are necessary to develop products and manufacturing process, to measure critical quality attributes and to ensure the quality of final products.
In this article, we discuss the application of QbD to analytical method development ahead of the new ICH Q14 guideline, whose goal is to harmonize the scientific approaches of Analytical Procedure Development. This proposed new guideline aims to improve regulatory communication between industry and regulators, and facilitate more efficient, sound scientific and risk-based approval as well as post-approval change management of analytical procedures.
Related content from this organisation
- SGS ISL marks two-year anniversary
- Whitepaper: Changing regulatory environment for nitrosamine impurities
- Technical bulletin: Streamline your drug development pathway from preclinic to FIH/POC
- Whitepaper: Are nitrosamines a concern for biologic manufacturers?
- Whitepaper: Navigating nitrosamine impurity testing