GMP(Good Manlfacturing Practices) certificate is issued by the Pharmaceutical Supervise Bureau of the PRC, meanwhile it is the certificate for the pharmaceutical enterprise by the PRC, the certificate for the product technology of the pharmaceutical enterprise, and meanwhile it is a supervise system for the quality of the medicine. All these guaranteed the safe using of the medicine for people.
The company should meet the following requirements to get the GMP certificate: Requirements for employee: the responsibility for the employee should be clear; professional training for the employee and the employee must have the basic knowledge of the field and the practical skills and must pass the exam. The management people of all departments must have the formal professional knowledge for the pharmaceutical quality management of the PRC.
Requirements for the producion environment: the company must have the reasonable layout. The production area must classified by the production process and clean level. The air level, area level and water level of the equipment and the whole area of company must meet the requirements of the production quality management regulation.
Requirements for production and quality: every product must have a exact production process; every product must have a production record of every production part. The quality management department must report directly to the leader group and has the equipment and technician with requested by the quality testing. And the company should set up the document filing system.
(Click to big) |
(Click to big) |
|
