USP 1227适用范围

兜兜

各位大神，最近在做微生物方法验证，已知USP 1223和EP 5.1.6是药典替代方法的验证，那么USP 1227的适用范围是哪些，按照药典方法进行方法验证或者叫做方法适用性研究，是否应该按照USP 1227进行，或者可以参考哪些章节进行？

USP 1227前面简介部分
This chapter provides guidelines for the validation of methods for the estimation of the number of viable microorganisms,
for the detection of indicators or objectionable microorganisms, for the validation of microbiological methods used in antimicrobial
effectiveness testing, and for the sterility testing of Pharmacopeial articles. It is generally understood that if a product
possesses antimicrobial properties because of the presence of a specific preservative or because of its formulation, this antimicrobial
property must be neutralized to recover viable microorganisms. This neutralization may be achieved by the use of a
specific neutralizer, by dilution, by a combination of washing and dilution, or by any combination of these methods.
The tests under Antimicrobial Effectiveness Testing á51ñ, Sterility Tests á71ñ, and Microbial Enumeration Tests á61ñ and Tests for
Specified Microorganisms á62ñ require the validation of recovery methods. To ensure that the results of the tests are credible,
neutralization of antimicrobial properties of the test solution is required before estimating the number of viable microorganisms.

小金库

感谢分享。