A strategy for population pharmaceutical quality assessment based on quality by design

Area of Science:

• Pharmaceutical Science
• Regulatory Science
• Quality Management

Background:

• Drug quality consistency evaluation is crucial from a regulatory standpoint, necessitating consideration of diverse manufacturing processes for identical drugs.
• Existing methods often lack a comprehensive approach to population-level pharmaceutical quality assessment, particularly concerning process variations.

Purpose of the Study:

• To develop and validate an assessment strategy for population pharmaceutical quality evaluation based on Quality by Design (QbD).
• To integrate descriptive and quantitative analysis methods, including improved Statistical Process Control (SPC), for characterizing process attributes and indicators.
• To establish a framework for risk assessment, visualization, and trend tracking in pharmaceutical manufacturing.

Main Methods:

• Established a descriptive analysis method based on QbD to define Critical Evaluation Attributes (CEAs).
• Developed a quantitative analysis method using an improved Statistical Process Control (SPC) approach to investigate Process Indicators (PIs) like mean distribution and batch-to-batch differences.
• Defined rules for risk assessment based on SPC parameters and limitations, visualizing results for better understanding of population pharmaceutical quality.

Main Results:

• The developed strategy effectively characterizes processes through CEAs and investigates PIs within the process population.
• Risk assessment rules were established, and visualization of SPC parameters and PI risks provided insights into population pharmaceutical quality.
• The strategy was successfully applied to generic drug consistency assessment, process risk assessment, and quality trend tracking.

Conclusions:

• The proposed assessment strategy enhances the understanding of drug quality consistency through process control and risk assessment.
• It provides data-driven information for regulatory approval, early warnings, and reducing adverse reactions.
• Dynamic population pharmaceutical quality tracking offers valuable insights for regulatory decision-making and emergency preparedness.