Analytical Quality by Design: A Tool for Regulatory Flexibility and Robust Analytics

Table 2

Conventional approach versus product development QbD versus analytical QbD.

Parameter	Traditional	Product QbD	AQbD
Approach	Based on empirical approach	Based on systematic approach	Based on systematic approach
Quality	Quality is assured by end product testing	Quality is built in the product and process by design and scientific approach	Robustness and reproducibility of the method built in method development stage
FDA submission	Including only data for submission	Submission with product knowledge and process understanding	Submission with product knowledge and assuring by analytical target profile
Specifications	Specifications are based on batch history	Specifications are based on product performance requirements	Based on method performance to ATP criteria
Process	Process is frozen and discourages changes	Flexible process with design space allows continuous improvement	Method flexibility with MODR and allowing continuous improvement
Targeted response	Focusing on reproducibility, ignoring variation	Focusing on robustness which understands control variation	Focus on robust and cost effective method
Advantage	Limited and simple	It is expended process analytical technology (PAT) tool that replaces the need for end product testing	Replacing the need of revalidation and minimizing OOT and OOS