GB 50073 "Clean Plant Design Code"
GB 50457 "Pharmaceutical Industry Clean Plant Design Code"
GB 50591 "Clean Room Construction and Acceptance Specification"
GB/T 16292 "Pharmaceutical Industry Clean Room (Area) Suspended Particle Testing Methods"
GB/T 16294 Testing Methods for Sedimentation Bacteria in Clean Rooms (Areas) of Pharmaceutical Industry
Documents and Records Required for Verification
1 Company's General Layout Plan
2 Clean Plant Floor Plan
3 Air Ducts Plan
4 Air Supply and Return Outlet Plans
5 Exhaust Ducts Plan
6 Air Filter Distribution Plan
6 Air filter distribution plan
7 Lighting plan
8 Air-conditioning unit instruction manual
9 Clean plant engineering acceptance report
10 Clean area environmental monitoring records
11 Third-party environmental monitoring report
12 Clean room management system