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The National Compulsory Engineering Construction Specification "General Specification for Pharmaceutical Production Water System" and "General Specification for Pharmaceutical Production Gas System" successfully passed the review.
Release time:2025-09-12 | Number of Views:8704

September 9-10, by the National Pharmaceutical Engineering as the first drafting unit to draft the national mandatory project construction specification "pharmaceutical production water system general specification" (submitted for review) and by the National Pharmaceutical Engineering Chongqing companyAs the first drafting unit, the national mandatory engineering construction specification "General Specification for Pharmaceutical Production Gas System" (draft for review) was held in Wuhan. The meeting was presided over by Miao, deputy secretary-general and director of the Standards Department of China Medical Engineering Design Association. Jiang Yu, Institute of Standard Quota, Ministry of Housing and Urban-Rural Development, xu Yunpeng, Engineering Construction Division, Planning Department, Ministry of Industry and Information Technology, state Drug Administration national drug production inspector (expert level) Zhai Tiewei, general Manager of Sinopec Shanghai Engineering Co., Ltd. and China Pharmaceutical Engineering Design Association president Shi Jingwei, song Yanjiang, Vice President and Secretary General of China Medical Engineering Design Association, secretary of the Party Committee of the National Pharmaceutical Engineering, director Chen Jinhui, party Secretary of Chongqing Company, chairman Hu Yu and representatives of all drafting units attended the meeting., from the pharmaceutical engineering construction design, construction, verification units, as well as pharmaceutical manufacturers. A group of nine senior experts attended the meeting.

President Shi Jingwei spoke on behalf of the organization unit of the standard drafting work, and Secretary Chen Jinhui spoke on behalf of the drafting unit.

In his speech on behalf of the Standard and Quota Department and the Standard and Quota Research Institute, Jiang Yu introduced the reform and drafting progress of China's mandatory project construction norms at the present stage, pointing out that mandatory norms are directly related to the bottom line requirements of ensuring people's health and life and property safety, ecological environment safety, and public safety. Pharmaceutical engineering construction is especially closely related to people's health and life safety, The specification should highlight the particularity of the pharmaceutical industry and coordinate with the current norms. Xu Yunpeng pointed out that the pharmaceutical industry is related to the national economy and people's livelihood., an important foundation for the construction of a healthy China, it is hoped that the water and gas use specifications will become mandatory general specifications that are systematic, advanced and operable. Zhai Tiewei introduced the preparation of China's sterile drug appendix (draft for comments) and the preparation of the "Guidelines for the Inspection of Pharmaceutical Water" (draft for comments), and asked the preparation team to do a good job of mandatory water use norms in construction. and the interface between the guidelines for the inspection of pharmaceutical water in terms of operation and maintenance.

At the review meeting, the expert group carefully listened to the report of the compilation group on the drafting process and main contents of the two specifications, and conducted in-depth discussion and review of the draft one by one. The expert group agreed that the two standards draw lessons from relevant laws and regulations, standards, guidelines and engineering practice experience at home and abroad, with sufficient basis, reasonable structure and comprehensive content, which fully reflects water for pharmaceutical production

, gas system professional attributes and quality control requirements, with strong operability, to promote China's pharmaceutical engineering construction and industry high-quality development has important guiding significance, agreed to submit the draft through the review.

the next step, the preparation team will be based on the review of the standard content to modify and improve, as soon as possible to form a draft for approval, according to the prescribed procedures to report, to promote the specification as soon as possible to promulgate and implement.


(Headquarters Scientific Research Management Department contribution)



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