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  • Basic Principles Of Good Manufacturing Practice Gmp - China

    price: contact company for price

    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.


    Company Contact:


    • Phone: 862062321333

    • Address: 7th Floor, Jingui Business Building, No.982 Congyu, Guangzhou, China

    • Email: Email


    Published date: January 9, 2013 -

    • Business Description: Osmunda Medical Device Consulting Organization

      (Guangzhou, Beijing, Shanghai, Suzhou, Shenzhen and Jinan) is the

      largest and most professional consulting company in the field of medical

      device in China. All Osmunda Consultant team members are from sizeable

      medical devices enterprises, well known notified bodies and testing

      organizations. We are well versed in global various medical device

      quality system certification and product registration, such as SFDA

      registration, QSR 820 system, FDA registration, ISO 13485 system, CE

      certification etc. Our service includes clean room design, clinical

      trail, third party audit, training of regulations and standards, etc.

      Our headquarters is in Guangzhou, and we have five branch offices (Beijing, Shanghai, Suzhou, Shenzhen, Jinan) which could provide high speed local services and communication. By far, Osmunda has successfully assisted nearly 1,200 domestic and foreign enterprises in achieving various medical devices registration and certification. We will be your trustful partner and your most professional guide.

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