Introduction:
The article discusses the importance of continuous monitoring and validation of analytical test methods in the production of cGMP biopharmaceutical products. It emphasizes that validation is not a one-time event but an ongoing process that must be tracked and trended to ensure reliable method performance after the initial validation phase.
- Validation of analytical methods is essential for producing cGMP biopharmaceutical products, as it ensures consistent performance under expected operational conditions.
- Continuous Method Verification (CMV) and Ongoing Procedure Performance Verification (OPPV) are crucial for monitoring the reliability and accuracy of validated methods post-validation.
- The interpretation of ICHQ2 performance parameters varies significantly among different analytical methodologies, highlighting the technical challenge in method validation.
- Invalid test runs can indicate operational issues or flaws in the methods, thus necessitating corrective actions or improvements in laboratory practices.
- Tracking and trending method performance is vital for quickly identifying problems and implementing meaningful corrective actions to ensure consistent quality control.
Conclusion:
The article underscores the necessity of continuous assessment of validated analytical methods in cGMP environments. This ongoing scrutiny aids in quickly identifying deviations from expected performance standards, thus safeguarding product quality and regulatory compliance. The discussion by Nadine Ritter at the upcoming BioProcess International Conference is anticipated to provide further insights into practical strategies for implementing effective tracking and trending systems in laboratory settings.
