Critical quality and performance attributes

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. 

Performance parameters reflect the outcome of a given step and indicate that the process gave the desired result [14] or quality attribute. They are uncontrolled performance variables [15] without a control action [35]. Their natural variation is defined by operating history specifically, their variability is characterized from known historical data or estimated based on similar process performance [35]. Similarly, output variables reflect the step outcome and indicate performance was acceptable in terms of performance attributes for the step (e.g., titer and yield) or properties of the product stream (e.g., product homogeneity, purity, contaminant levels, and chromatography peak shape) [3,14]. Still another term used is critical Ys (analogous to dependent variables), defined as product and process output variables that relate to critical quality attributes (CQAs), which are measurable outputs of each process step that are used to provide evidence that the step performed correctly [37]. 

Personal quality pertains to the quality of personal attributes, trust, and characteristics that enable individuals to maintain excellent work ethics and performance. The critical factors in this area include personal attitude, skills, abilities, work habits, behaviors, integrity, trustworthiness, loyalty, dedication, and commitment to the successful achievement of organizational and personal mission and priorities. 

The milled extrudate s particle size is often a critical quality attribute for the drug product performance for many reasons. It is well known that the dissolution rate of a particle is determined in part by the particle s size and surface area. For polymer-based materials such as extrudate, particle size can influence phenomena such as swelling and gelling, which may or may not be desirable for the product performance. Particle size may also affect powder flow in feeders and hoppers and can result in segregation risks that impact content uniformity in the final drug product. 

Target Product Profile and Critical Quality Attribute The target drug profile consists of prospective and dynamic summary of the characteristics of a drug that should be achieved in order to reproducibly deliver the therapeutic benefit the target product profile (TPP) sets an important number of performance parameters that will be the... 

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