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GMP 资料,华纳的

GOOD MANUFACTURING PRACTICES RULES & REGULATIONS
1. Change to uniform and shoes provided by company before going into production areas.
2. Wear hair covering in all manufacturing and packaging areas. All hair must be contained as completely as possible. In warehousing area hair covering must be worn when opening raw material containers.
3. Keep uniforms, shoes, socks and gloves clean and ready for inspection at all times. Uniforms are to worn only in the promises and never to be worn outside.
4. Always wash hands before starting work and after each absence from the work area. Hands must be washed thoroughly with soap and water and dried thoroughly by hand blower. Never touch products with bare hands, use clean gloves.
5. Smoking in production area plant corridors and warehousing area is strictly prohibited.
6. Polish of all kind on fingernails are prohibited in manufacturing and packaging areas. Polish may chip and contaminate the product.
7. Watches, pagers and jewelry, such as fancy rings, dangling wrist jewelry, exposed necklaces and clip-on earring should not be worn in production areas.
8. No shirt pockets above the waist should have any items, such as tools, pens, glasses etc., that may accidentally fall into the product.
9. Gowns are provided for office staff and visitors to protect the product from street clothes which carries bacteria. Gowns and hair coverings are to worn in production areas. They are not allowed in canteen, outsides factory premises and toilets. Before going into toilets, gowns must be taken off and hung on provided hangers.
10. Food and drink are not permitted in manufacturing, packaging, warehousing areas and locker rooms. This is to prevent the possibility of contaminating the product. Food and drink are attractants for rodents and insects.
11. Production employees must notify their supervisor if you have septic cuts, spots, boils or skin problems or contagious and infectious disease i.e. respiratory infections such as sore throat, cold, bowel upsets which may adversely affect the safety of other employees or the quality of the product.
12. Keep doors closed to prevent air-born contaminants, birds, rodents and insects from outside which may affect our products.
13. Leave unnecessary items in your lockers before entering the production areas.
14. The Maintenance Department who is responsible for an ongoing preventive maintenance program must always be alert to possible product contamination by oil, metal chip, loose or small parts during repair.
15. All outside contractors need Work Permit.
16. Observe and remove any loose tools, screws, nut, bolts or small items near product contamination.
17. Equipment not in use may become a home for contaminants. Always clean and store equipment properly.
18. Store containers for raw materials off the floor to avoid contaminating our products.
19. All raw materials, product and packaging materials drawn from warehouse must be dusted and thoroughly cleaned before sending into production areas.
20. No raw materials, product, or packaging materials without Q.A. “Approved” label are to be used in production in all areas.
21. Manufacturing instructions must be strictly followed by production employees. No short-cut or changes of any kind to the process specified by the Company is allowed. Suggestion for changes may be made to your supervisor for trial before official change can be made.
22. Whenever you have a question about the manufacturing instruction, ask your supervisor. Do not guess.
23. Do not put unwrapped product that had fallen on the floor back to the batch.
24. Always keep your working areas clean and tidy. Clean up regularly and thoroughly.
25. Whenever you are not sure of the quality of the product you are producing, or suspect possible contamination of any kind, notify your supervisor immediately.



Prepare by: Q.A. Department
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colin (威望:0) (上海 徐汇)

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很好!可以参考!

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