Article 8 To establish a pharmaceutical production enterprise, the following conditions must be met:

(1) Having qualified pharmaceutical technicians, engineering technicians and corresponding skilled workers according to law;

(2) Having factories, facilities and sanitary environment suitable for its pharmaceutical production;

(3) Having institutions, personnel and necessary instruments and equipment capable of quality management and quality inspection of the drugs produced;

(4) Having rules and regulations to ensure the quality of drugs.

Article 9 Pharmaceutical production enterprises must organize production in accordance with the good manufacturing practice formulated by the pharmaceutical supervisory and administrative department of the State Council in accordance with this Law. The pharmaceutical supervisory and administrative department shall, in accordance with the provisions, certify whether the pharmaceutical production enterprises meet the requirements of good manufacturing practice; Those who pass the certification will get the certification certificate.

The specific implementation measures and steps of good manufacturing practice shall be stipulated by the drug supervision and administration department of the State Council.

Extended data:

According to the Drug Administration Law of People's Republic of China (PRC):

Tenth in addition to the processing of Chinese herbal pieces, drugs must be produced in accordance with the national drug standards and the production process approved by the drug supervision and administration department of the State Council, and the production records must be complete and accurate. Drug production enterprises must report to the original approval department for examination and approval if they change the production process that affects the quality of drugs.

Chinese herbal pieces must be processed in accordance with national drug standards; If there are no provisions in the national drug standards, it must be processed in accordance with the processing standards formulated by the pharmaceutical supervisory and administrative departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government. The processing specifications formulated by the pharmaceutical supervisory and administrative departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government shall be reported to the pharmaceutical supervisory and administrative departments of the State Council for the record.

Article 11 The raw materials and auxiliary materials needed for the production of drugs must meet the requirements of medicinal use.

Article 12 pharmaceutical production enterprises must conduct quality inspection on the drugs they produce; Those that do not meet the national drug standards or are not processed in accordance with the processing standards for Chinese herbal pieces formulated by the pharmaceutical supervisory and administrative departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government shall not leave the factory.

Article 13 With the approval of the pharmaceutical supervisory and administrative departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government, pharmaceutical production enterprises may accept the entrustment to produce pharmaceuticals.

Baidu Encyclopedia-People's Republic of China (PRC) Drug Administration Law