Method lifecycle management
In modern drug development, an analytical method is a dynamic asset that evolves alongside your product. Both ICH Q14 and USP General Chapter <1220> establish a holistic framework for Analytical Procedure Lifecycle Management. This framework shifts the industry away from traditional, one-time validation exercises toward a continuous, Quality by Design (QbD)-driven process.
At Anabiotec, we implement robust Lifecycle Management strategies to ensure your analytical procedures remain fit for their intended purpose, consistently meeting regulatory expectations from early-stage clinical trials through to routine commercial release.
Our Phase-Appropriate Lifecycle Approach
We understand that a one-size-fits-all approach does not work in drug development. The principles of Method Lifecycle Management must be applied in a phase-appropriate manner, balancing scientific flexibility during early clinical phases with strict GMP compliance as you approach commercialization. It ensures methods remain fit for their intended purpose throughout their entire lifespan, supported by global standards like ICH Q14 and and USP <1220>.
Analytical procedure development (Phase 1) Analytical procedure Validation (Phase 2) Ongoing method performance verification (Phase 3)
Continuous verification at Anabiotec
To successfully maintain a method's validated state over years of routine operation, lifecycle management must control for analytical drift and reagent variability. At Anabiotec, we achieve this through two integrated operational pillars:
Reference standard management
- Reference stock management using GMP (LIMS) and monitoring of quantities in real-time.
- Periodical requalification according reference standards management program.
Statistical data trending and control
- Trending of acquired stability data using statistical software.
- Lifecycle management of analytical methods by continuous method performance monitoring.
- Monitor analytical procedure variability using control charts and statistical software tools.
Optimize Your Method Lifecycle Today
Ensure your analytical procedures meet regulatory expectations at every stage of the product development lifecycle.