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1. Drugs industry must have sufficient qualified technicians and meet the standard of drugs production. Moreover, they must be responsible for the drug production and quality production and realize clearly what they should do.
2. Operators should be trained so that they can operate correctly.
3. The productions must be produced following the quality standard.
4. Enterprises must make production order according to production task, but not production plan.
5. All productions must be produced under the technological procedure, checked systematically and can be proved to meet the quality and specification standard.
6. Make sure that production factory, environment, production facility and hygiene meet the requirement.
7. Materials, packing containers and tags which meet specification standards.
8. Suitable storage and transporting equipment.
9. The whole production process must be controlled and managed rigorously and efficiently.
10. The key steps and main changes of processing production must be checked.
11. qualified quality inspectors, facilities and labs.
12. It must be recorded by man or recorder during the production so that all the production steps which are finished meet the specification and instructions and products meet prospective quantity and quality. Besides, any deviation must be recorded and investigated.
13. The danger which affect the storage and selling of the products must reduce to the minimum.
14. Set up an effective system that can withdraw any products through selling and supplying.
15. Know about the clients’ ideas and investigate the cause of quality problems so that we can put forward some measures to handle and prevent it.
16. New production process, productive technology, facility and material must be checked to achieve the anticipated results.
Osmunda, the only consulting organization which focuses on the field of medical device, has set up seven wholly owned subsidiaries in Guangzhou, Beijing, Shanghai, Shenzhen, Jinan, Suzhou and America. It has provided fully solutions to more than 1500 medical device factories successfully.
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