USP <1223> - Validation of Alternative Microbiological Methods

What it says

This chapter provides guidance on validating alternative microbiological methods, such as rapid methods, to show they are equivalent or better than the compendial method they replace. It covers validation parameters appropriate to qualitative, quantitative and identification tests, such as accuracy, precision, specificity, limit of detection, limit of quantification, linearity, range, ruggedness and robustness, and the comparison with the existing method.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• Adopting a rapid method requires evidence that it is at least as reliable as the method it replaces.
• The parameters needed depend on the type of test, so the validation plan should say which apply and why.
• The method must also be suitable for the product, so product-specific verification is often needed.

What inspectors look for

• Whether validation data show equivalence to the compendial method.
• Whether the method was shown suitable for the product tested.
• Whether the validation plan and acceptance criteria were set in advance.

Related regulations