Implementing scientifically sound practices during drug development: An industry perspective from analytical...

Area of Science:

• Pharmaceutical Science
• Analytical Chemistry
• Regulatory Affairs

Background:

• Analytical development is crucial for pharmaceutical technical development.
• Existing practices may not fully cover activities impacting regulatory submissions.
• Nine pharmaceutical companies collaborated to define minimum expectations.

Purpose of the Study:

• To establish a framework for Scientifically Sound Practices (SSP) in pharmaceutical technical development.
• To ensure data integrity and regulatory compliance for activities outside current Good Manufacturing Practices (cGMP).
• To promote a flexible, "fit for purpose" approach across the product lifecycle.

Main Methods:

• Expert consensus and collective experience sharing from nine pharmaceutical companies.
• Development of a comprehensive SSP framework outlining best practices and recommendations.
• Focus on activities supporting technical development and lifecycle management.

Main Results:

• The SSP framework provides a structured approach to analytical development.
• It covers diverse activities like product characterization, comparability, and process development.
• Emphasis on good documentation practices for data accuracy, completeness, and traceability.

Conclusions:

• SSP ensures high data quality and scientific scrutiny in analytical development.
• This approach supports robust control strategies and regulatory submissions (e.g., CMC, NDA/BLA/MAA).
• Adoption of SSP fosters a science- and risk-based pharmaceutical quality system, enhancing innovation and lifecycle management.