Glossary · ICH guidelines
ICH Q2(R2) and Q14 (analytical procedures)
Also known as: ICH Q2, ICH Q14, Q2(R2), Validation of Analytical Procedures, Analytical Procedure Development, Analytical target profile (ATP)
ICH Q2(R2) and ICH Q14 are companion ICH guidelines on analytical procedures for medicines, both adopted in November 2023. Q14 covers the science- and risk-based development of analytical procedures and their lifecycle; Q2(R2) covers the validation of analytical procedures used for release and stability testing.
- ICH
- Pharma
In one sentence
ICH Q14 covers analytical procedure development and lifecycle; ICH Q2(R2) covers validating those procedures. Both were adopted in November 2023.
Example
A biologics developer defines an analytical target profile for a potency assay under ICH Q14, develops the assay against it, and then validates accuracy, precision, specificity and range under ICH Q2(R2) before using it for batch release.
How it applies
- ICH Q14: Describes a minimal and an enhanced approach to development. The enhanced approach can use an analytical target profile (ATP), a statement of what the procedure must measure and how well, and knowledge that supports post-approval changes under ICH Q12.
- ICH Q2(R2): Describes the performance characteristics to be validated depending on the purpose of the procedure, such as specificity or selectivity, working range, accuracy and precision. The revision extends the guideline to techniques such as multivariate and spectroscopic methods.
- Lifecycle: Development, validation, routine use and changes are treated as one lifecycle. Development data can be used in validation where justified.
- Scope: Procedures for release and stability testing of drug substances and drug products, chemical and biological, in marketing authorization applications.
- Technical documentation: Validation protocols and reports go into CTD module 3 sections on analytical procedures. Record the intended purpose and acceptance criteria before testing, and keep the raw data under data integrity controls.
Development (Q14) vs. validation (Q2(R2))
Development answers which procedure fits the purpose and why; validation demonstrates, against predefined criteria, that the chosen procedure performs as intended. This mirrors the general distinction between design work and validation: a well-developed procedure still needs validation, and a validated procedure is only as fit as the purpose it was developed for.