Three, fill out the "Application for Administrative License" requirements
1. Fill in the content is complete and accurate;
2. "Applicant" name shall be consistent with the industrial and commercial administration issued by the "Business Name Pre-approval Notice" or "Business License" name;
3. "Legal representative" or "Business License" on the same;
3. Enterprise Name Pre-approval Notice" or "Business License" on the name of the same;3. "Legal representative" or "person in charge of" shall be consistent with the board of directors' resolutions, bylaws or appointment documents;
4. "Production and business address" shall be consistent with the "registered address"; and with the certificate of property rights or lease contract (including proof of property rights) or business premises on the address of the same;
5. Production mode fill in the production, sub-assembly.
6. Production items fill in sanitary products, disinfectants, disinfection equipment.
7. Product categories according to the "production category classification catalog" (see the annex) listed in the category to fill out.
Four, the standard format of the application materials
(a) list of production equipment.
×××× unit production equipment list
Equipment No. Equipment name Model specification Quantity Use Manufacturer
(b) Inspection equipment list.
×××× Unit Inspection Equipment List
Equipment No. Equipment, Instrument Name Model Specification Quantity Purpose Manufacturer
(c) Proposed production catalog.
×××× Unit Product Catalog
Serial No. Product Name Object of use or scope of use Formulations/models
(D) Quality Assurance System Documentation.
1. Standard operating procedures for the production of sterilization products.
2. Personnel job responsibility system.
3. Personal hygiene system for production personnel.
4. Equipment procurement and maintenance system.
5. Hygiene and quality inspection system.
6. Sampling system.
7. Material procurement system.
8. Raw material and finished product storage management system.
9. Sales registration system.
10. Product complaint and handling system.
11. Unqualified products recall and handling system.
V. Requirements for test reports
Producers should provide 1 year of production environment and production of water test reports, test reports should be issued by the measurement of certified inspection agency.
(A) sanitary products manufacturers test items.
1. Production workshop environment:
(1) purification requirements of the production workshop: detection of purification workshop temperature, relative humidity, air inlet wind speed, indoor and outdoor pressure difference, the number of dust particles in the air ≥ 0.5 μm and ≥ 5 μm, the workshop air, the total number of bacteria on the surface of the workbench, the total number of bacteria on the surface of the worker's hand colonies and pathogenic bacteria.
(2) No purification requirements of the production workshop: detection of production workshop bench surface, workshop air bacterial colony total number of workers hand surface bacterial colony total number and pathogenic bacteria.
2. UV lamp radiation intensity: the use of ultraviolet light to disinfect the workshop air production enterprises.
3. Disinfection and sterilization effect verification: self-provided disinfection sterilizer disinfection of the production of disinfection products for sterilization treatment of production enterprises.
4. Production of water: contact lens care products and antibacterial (inhibitory) preparation of water for the production of water in accordance with the "Chinese People's *** and the State Pharmacopoeia," the second part of the purified water testing of the whole project, contact lens care products should also be done in the production of water aseptic test.
(B) disinfectant manufacturers test items.
1. Purification requirements of the production plant: detection of purification workshop temperature, relative humidity, air inlet wind speed, indoor and outdoor pressure difference, the number of dust particles in the air ≥ 0.5 μm and ≥ 5 μm, the total number of bacterial colonies on the surface of the bench.
2. UV lamp radiation intensity: the use of ultraviolet light for workshop air disinfection of production enterprises.
3. Production water: sterilizers, skin and mucous membrane disinfectants production water in accordance with the "People's Republic of China *** and the National Pharmacopoeia," the second part of the purified water test the whole project.