1. Drugs production enterprises must h***e enough technicians who are qualified and meet the standard of drugs production. Moreover, they must resp***ible for the drug production and quality production and know clearly what they should do.
2. Operators should be trained so that they can operate correctly.
3. Enterprises must ensure the production are produced and controlled under the quality standard.
4. Enterprises must make production order according to production task, but not to production plan.
5. All production must produced under the technological procedure, checked systematically and can be proved to meet the quality and specification standard.
6. Ensure that production factory, environment, production facility and hygiene should meet the requirements.
7. Materials, packing containers and tags which meet specification standa***.
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 instructi*** 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 decrease to the minimum.
14. Set up an effective system that can withdraw any products through selling and supplying.
15. To know about the clients’ ideas and to investigate the cause of quality problems so that we can put forward some measures to handle it and prevent it not to happen again.
16. A new production process, productive technology, facility and material must be checked to achieve the anticipated results.
O***unda, the only c***ulting organization which focuses in the field of medical device, in which there are tens of top c***ultants who can provide GMP certification, GMP certification c***ulting, GMP system certification c***ulting for enterprises, has set up seven wholly owned subsidiaries in Guangzhou, Beijing, Shanghai, Shenzhen, Jinan, Suzhou and America, has provided fully soluti*** to more than 1500 medical device factories successfully.