BioPhorum publishes Guidance for ICH Q2(R2) and Q14 Implementation

BioPhorum recently published a new document entitled "Best practices for the development, validation and registration of analytical procedures—Implementation of ICH Q2 (R2) and Q14 for biologics." This publication from the end of March 2025 provides recommendations for aligning analytical procedure development and validation practices with the recently updated International Council for Harmonisation (ICH) guidelines Q2(R2) and Q14, which were adopted in late 2023.

The guidance focuses on the integration of Quality by Design (QbD) concepts into analytical procedure development. A central element is the Analytical Target Profile (ATP), which defines the intended purpose of the procedure, the attributes to be measured, and the associated performance criteria.

The 58-page document is structured into the following main chapters:

• Introduction
• Implementing ICH Q14 for the development of analytical procedures
• Validation of analytical procedures
• Conclusion
• Summary tables, glossary, and references

Key aspects discussed in the document include:

• Definition and documentation of the ATP
• Technology selection and the role of the ATP in technology selection
• Analytical procedure development
• Analytical procedure lifecycle management (APLCM)
• Validation strategies
• Use of platform technologies and prior knowledge

The document also provides practical examples and documentation templates to support implementation, such as examples of ATP formulations, technology selection scoring systems, and documentation for parameter range determination.

The authors conclude that "the implementation of ICH Q2 (R2) and Q14 guidelines for the development, validation and registration of analytical procedures represents a significant advancement in the biopharmaceutical industry. By adopting a systematic, risk-based approach, these guidelines ensure that analytical procedures are robust, reliable and fit for their intended purpose throughout the product lifecycle."

The full document is available for download on the BioPhorum website.