Multivariate Spectroscopic Method Lifecycle Management as Part of the Quality Management System

Area of Science:

• Pharmaceutical Science
• Analytical Chemistry
• Chemometrics

Background:

• Multivariate model-based spectroscopic methods are crucial in pharmaceutical development.
• Model maintenance throughout the lifecycle is essential for these methods.
• Regulatory reporting for model changes poses challenges to routine use, as identified by a 2019 IQ survey.

Purpose of the Study:

• To introduce industry best practices for multivariate method and model lifecycle management.
• To address regulatory hurdles hindering the routine application of these techniques.
• To promote the use of multivariate methods in pharmaceutical development and commercialization.

Main Methods:

• Literature review of industry best practices.
• Analysis of survey data from the International Consortium for Innovation and Quality in Pharmaceutical Development (IQ).
• Case studies demonstrating the application of Established Conditions and Post-Approval Change Management Protocols.

Main Results:

• Identified regulatory reporting categories as a significant hurdle.
• Proposed best practices for lifecycle management within a Pharmaceutical Quality System.
• Demonstrated the utility of Established Conditions and Post-Approval Change Management Protocols for regulatory flexibility.

Conclusions:

• Implementing robust lifecycle management strategies is key to overcoming regulatory challenges.
• Leveraging Established Conditions and Post-Approval Change Management Protocols can facilitate regulatory flexibility.
• Adoption of these practices will encourage the routine use of multivariate spectroscopic methods in the pharmaceutical industry.