Harmonization in Microbial Limit Test of USP and EP | Abstract

Asian Journal of Pharmaceutical Technology and Innovation (ajpti)

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Harmonization in Microbial Limit Test of USP and EP


Dr. Dilip Maheshwari, Pragati Vanavi

The harmonized versions have been published and it’s continuing till both the country is ready for harmonization. Japan is also included in harmonization process. The harmonized chapters do not differ in most case from the drafts published in 2003 .This article briefly describes harmonized USP chapters {61} microbial enumeration , {62} absence of specified micro organism, {1111} microbiological attributes to no sterile pharmaceutical product .The format of USP chapters changes drastically with this harmonization whereas the microbial limit tests were two chapters in USP 29(5,6) they are now modified now in modified version to copy the European version. It is most important to the people who want to carry out the tests in both the country and want to export product in both country. The implementation of the tests was in different schedule in US and in Europe.

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