Validating the analytical method of drug quality control aims for proving that the method in use is suitable for the corresponding detection requirements.

In the quality control of biological products, bioactivity/potency is a key quality attribute reflecting the effectiveness of biological products. To ensure the applicability of the corresponding detection methods, the premise is to validate the methods in compliance.

The Guidelines expounds the requirements for formulating validation plans, specific strategies for each validation indicators, recording the validation results, and monitoring and re-validating the methods, in an effort to standardize and guide the validation of new or revised bioactivity/potency determination methods for biological products.

Bioactivity/potency determination in the Guidelines mainly refers to the relative potency determination, which compares the biological reaction of the test product with the reaction produced by the known standard product, so as to quantitatively determine the potency of the test product in comparison to the standard one.