Tag: Regulatory.

Abstract Essentially, the QbD approach identifies the quality attributes of the product based on scientific rationale as opposed to attempting to fit the proverbial square peg into a round hole through a trial - and - error approach. This rational design approach goes further to identify the limiting factors of each unit operation and provides the means of attempting to correlate how each unit operation affects the final product quality attributes. To apply QbD as a systemic approach, the company starts by understanding, step by step, the space design, the design of the dosage form, the manufacturing process, and the critical process parameters to be controlled in order to reach the new building block which is the expectation of variances within those critical process parameters that can be accepted. This approach allows the establishment of priorities and flexible boundaries in the process [avf_view name="Article Addons" view-id="66d98451c48e3"]