Drugs must be produced by enterprises. According to the Regulations on Quality Management of Pharmaceutical Industry, the details are as follows:
Article 9 Newly-built pharmaceutical production enterprises shall be approved by the pharmaceutical administrations (head offices) of provinces, autonomous regions and municipalities directly under the Central Government before they can be started. Upon completion, it will be inspected and accepted in accordance with the requirements of the Drug Administration Law. Those who pass the examination shall be issued a certificate of pharmaceutical production enterprise, and the enterprise shall apply to the administrative department of health for a license of pharmaceutical production enterprise and to the administrative department for industry and commerce for a business license.
Article 27 Quality accident reporting system. When quality accidents occur in pharmaceutical production and trading enterprises, they should be dealt with seriously and promptly, and reported to the competent authorities step by step in time. Quality accidents are divided into general accidents and major accidents. Scope of major quality accidents:
(1) Finished products are scrapped in batches due to quality problems;
(2) Drugs are returned in batches due to quality problems during the liability period or warranty period;
(3) The whole batch of drugs in the warehouse can no longer be used for drugs due to improper storage, such as moth-eaten, mildew, deterioration, pollution, damage, etc.
(4) The product is adulterated with drugs, seriously adulterated with foreign substances or other poor quality, which seriously threatens personal safety or has caused medical accidents.
Extended data:
"Regulations on Quality Management of Pharmaceutical Industry" Article 29 Responsibilities of the Quality Management Office of the Pharmaceutical Administration (head office) of all provinces, autonomous regions and municipalities directly under the Central Government:
(1) is responsible for implementing the national laws, regulations, guidelines and policies on quality, standards and measurement, organizing the implementation of total quality management, and formulating detailed rules and organizing the implementation in combination with the actual situation in the region.
(2) To supervise and inspect the establishment and perfection of quality control and quality inspection institutions for pharmaceutical production and operation enterprises in this region, organize the training of quality control and quality inspection personnel, and continuously improve their technical and professional quality;
(3) Organize standardization, measurement, merit appraisal and quality management group activities;
(4) To supervise and inspect the implementation of the Standards for the Administration of Pharmaceutical Production, the Standards for the Administration of the Quality of Pharmaceutical Commodities, the Measures for the Administration of the Quality of Chinese Herbal Pieces, the Interim Measures for the Administration of the Quality of Chinese Medicine Industry and the Measures for the Administration of the Quality of Medical Devices;
(5) To be responsible for organizing the issuance of the Certificate of Pharmaceutical Production Enterprise, the Certificate of Pharmaceutical Trading Enterprise and the Pharmaceutical Production License, and to be responsible for the examination of the application for the Pharmaceutical Product Production License by enterprises;
(6) To be responsible for organizing the investigation and analysis of major quality accidents, and put forward treatment opinions and preventive measures.
Baidu Encyclopedia-Some Provisions on Quality Management of Pharmaceutical Industry