RT Journal Article
SR Electronic
T1 A Guide to Navigating Quality Control Requirements for Alternative and Rapid Microbial Methods in Sterility and Mycoplasma Testing Across the Asia Pacific Region
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP pdajpst.2024-003031.1
DO 10.5731/pdajpst.2024-003031.1
A1 Gutierrez, Juliana
YR 2025
UL http://journal.pda.org/content/early/2025/09/16/pdajpst.2024-003031.1.abstract
AB While alternative and rapid microbiological methods (ARMM) have gained broader acceptance in Europe and the United States, where guidance on their validation and implementation has been made available by the European Pharmacopoeia and United States Pharmacopoeia and their use has been supported by both regulators and industry groups, their adoption in other regions such as Asia Pacific has been more limited. This article aims to review the regulatory landscape for ARMM in the Asia Pacific region, focusing specifically on sterility and mycoplasma testing. It will examine relevant pharmacopoeial chapters and local guidelines in key pharmaceutical markets, including China, Taiwan, Japan, South Korea, India, Indonesia, Thailand, and Vietnam. The analysis will be limited to markets with their own pharmacopoeia, providing a comprehensive guide to navigating the landscape of existing and future regulations while assessing the readiness of these markets to adopt these new technologies.