On June 21, the National Pharmacopoeia Commission announced the draft standard of the sealing guidance principle of sterile drug packaging system. This is the second public announcement, and the publicity period is one month.

The sealing guidance principle of sterile drug packaging system focuses on the leakage mode, leakage risk, sealing test method selection, method verification and result evaluation of sterile drug non-porous packaging system.

The National Pharmacopoeia Commission requires relevant units to carefully review and verify. If there are any objections, they should promptly go to its official website (https://www.chp.org.cn) to provide online feedback, and attach relevant instructions, experimental data and contact information. The letter must be printed and stamped with the official seal, and the personal letter must be printed and signed by the person himself and mailed to the communication address of the National Pharmacopoeia Commission.

If no reply is made after the publicity period expires, it will be deemed that there is no objection to the publicized draft standard.

Contact: Chen Lei, Zhu Ran

Tel: 010-67079566, 67079581

Mailing address: Office of the National Pharmacopoeia Committee, Building 11, Fahua South Lane, Dongcheng District, Beijing

Postal code: 100061

Attachment: 9628 Company draft of the Guidelines for Sealing of Sterile Drug Packaging Systems (Second Edition)