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6th April 2022
ICH guideline Q2(R2) on validation of analytical procedures - Public Consultation
This guideline applies to new or revised analytical procedures used for release and stability ICH Q2(R2) Guideline testing of commercial drug substances and products (chemical and biological/biotechnological). The guideline can also be applied to other analytical procedures used as part of the control strategy (ICH Q8-Q10) following a risk-based approach. The scientific principles described in this guideline can be applied in a phase-appropriate manner during clinical development. This guideline may also be applicable to other types of products, with appropriate regulatory authority consultation as needed.