Rx-360 Reaffirms Compliance with NMPA Requirements Download the Position Letter
Rx-360 is committed to supporting the global pharmaceutical industry in meeting regulatory standards worldwide. In response to the National Medical Products Administration (NMPA) (China) release of Appendices One and Two of Article 310 of the Good Manufacturing Practice for Pharmaceutical Products (2010 Revision), we have outlined our position on Provision 10 regarding independent quality audits.
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Access Rx-360’s Summary and Translations of the New NMPA GMP Appendices
Our Joint Audit Program is fully aligned with NMPA expectations, ensuring audits are conducted by qualified professionals under robust governance and documented procedures. This includes clear qualification criteria, transparent selection principles, and formal approval processes—all designed to meet the highest standards of compliance.
Contact us to learn how Rx-360 can help your organization demonstrate adherence to these requirements and maintain regulatory confidence.
The development of this resource was supported by Rx-360’s Supplier Quality Working Group.