Development of a Risk-based Quality System for CMC R&D Laboratories in Drug Development

Drug development requires extensive research and development (R&D), especially in Chemistry, Manufacturing, and Controls (CMC), to optimize manufacturing processes and meet regulatory requirements. While there are clear regulatory requirements for CGMP activities, specific guidance for non-CGMP studies in R&D laboratories is lacking. This leads to uncertainties regarding data integrity, regulatory acceptability and economic risks. Some companies apply unnecessarily strict CGMP/GLP requirements, while others use unstructured best practices, leading to quality risks.

An article in the Journal of Pharmaceutical Sciences proposed a risk-based quality system for CMC R&D laboratories to ensure the reliability and traceability of data. It is based on three quality tiers:

• Tier 0 includes exploratory studies with low regulatory relevance and few documentation requirements.
• Tier 1 includes non-CGMP-supporting studies used for process development, stability analyses and product characterisation, with increased documentation and standardisation requirements.
• Tier 2 comprises regulatory relevant studies used in validation and authorization documents with the highest requirements for reproducibility and data availability.

The implementation of such a system requires clear documentation standards, quality controls and the assurance of data integrity. Incorrect or incomplete data could lead to regulatory problems and financial losses. It should therefore be ensured at an early stage that regulatory requirements are integrated into R&D quality assurance.

In the light of accelerated approval procedures and increasing data quality requirements, structured R&D CMC quality assurance is essential. It enables the reusability of data, regulatory compliance and investment security. In this way, innovation and regulatory acceptance can be reconciled and long-term success in drug development ensured. Read the full article "Quality risk management and data integrity in R&D laboratories supporting CMC lifecycle of biological products" on the ScienceDirect website.