Quality by Design (QbD) is a modern, scientific approach that formalizes product design, automates manual test ing, and streamlines troubleshooting. It uses a system atic approach to ensure quality by developing a thorough understanding of the compatibility of a finished product to all of the components and processes involved in manufac turing that product. As stated in Q8, the International Conference on Harmonization (ICH) guidance document on pharmaceutical development, drug product should meet its intended product performance as well as meet the needs of patients.
Although the strategy for pharmaceutical development may vary from company-to-company and/or from product-to-product, Adsurgo can provide a systematic approach defined by enduring QbD principles.
- Design and analysis of experiments
- Analysis of Variance
- Statistical Process Control
- Process validation
- Process capability
