Product design critical quality attributes

Quality by design Product validation Critical quality attributes Process parameters Product life cycle Target product quality profile Formulation... 

The basic concepts of stability data evaluation are the same for single- vs. multifactor studies and for full- vs. reduced-design studies. Data evaluation from the formal stability studies and, as appropriate, supporting data should be used to determine the critical quality attributes likely to influence the quality and performance of the drug substance or product. Each attribute should be assessed separately and an overall assessment made of the findings for the purpose of proposing a retest period or shelf life. The retest period or shelf life proposed should not exceed that predicted for any single attribute. 

This section is structured to provide the reader an overview of pharmaceutical applications of melt extrusion to enhance the delivery of pharmaceutical products. The first section on formulation design covers aspects related to the composition of pharmaceutical dispersions. It highlights the important properties of drugs and carriers to achieve the desired critical quality attributes while... 

Understanding quality perception. The starting point of a CQP-based quality assurance system should be the clear understanding of which product attributes are considered important and contribute to the quality perceptions of target consumers. This will help focus the system to control and assure only those attributes that are critical for quality perception. Decision-supporting tools can be found in the areas of consumer research, sensory studies, and new product design. 

Process characterization represents the methods used to determine the critical unit operations or processing steps and their process variables, that usually affect the quality and consistency of die product outcomes or product attributes. Process ranging represents studies that are used to identify critical process or test parameters and their respective control limits, which normally affect the quality and consistency of the product outcomes of their attributes. The following process characterization techniques may be used to designate critical unit operations in a given manufacturing process. 

To control the quality of the product, any relationship among the critical raw material attributes, process parameters, and quality attributes for each process should be established dining development. In addition, limits need to be specified for critical process parameters that define the design space where the quality of the product is guaranteed. 

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