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Design Specification for Pharmaceutical Industry Clean Room

| 2017-12-12

Editorial department: State Pharmaceutical Administration Shanghai Medical Design Institute

Approval Department: State Pharmaceutical Administration

Date of implementation: January 1, 1997

Preparation instructions

In order to further implement GMP in China's pharmaceutical industry and to meet the needs of the construction of clean industrial buildings in the pharmaceutical industry, the State Pharmaceutical Administration has decided to organize the preparation of the "Code for Design of Clean Industrial Buildings for Pharmaceutical Industry" by the GMP.

This code is edited by Shanghai Medical Design Institute, Comrade Mu Dehua, Wuhan Medical Design Institute, Chongqing Medical Design Institute and other units. In the process of preparation, he paid extensive attention to the opinions of relevant parties in the pharmaceutical industry. He successively organized experts in pharmaceutical design institutes and large and medium-sized backbone enterprises to make serious lectures and revisions, and implemented the GMP.GSP Committee Fables in principle and passed in principle. Afterwards, the Bureau of Comprehensive Economic Affairs (original plan) consulted the experts and leaders of the Pharmaceutical Administration and the Drug Administration Office of the Ministry of Health on the main contents of the norms and got their understanding and support. On this basis, the Bureau GMP Design Code professional group made a revision of this specification finalized.

This standard compilation work with the progress of GMP at home and abroad and the construction and use of clean industrial plants in the pharmaceutical industry, put forward the basic requirements for the design of clean industrial buildings in China's pharmaceutical industry. All units in the new construction, renovation and expansion of engineering design in accordance with the implementation. And seriously sum up experience, put forward amendments to make this specification more and more perfect.

State Pharmaceutical Administration

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