The state food and drug administration about print and distribute to strengthen the supervision and administration of pharmaceutical excipients to the relevant provisions of the notice
The provinces, autonomous regions and municipalities directly under the food and drug administration (fda) :
In order to further strengthen the pharmaceutical excipients production and use of management, to ensure drug quality, on the basis of the pharmaceutical administration law of the People's Republic of China and its implementing regulations and other laws and regulations, the state food and drug administration to make the relevant provisions of strengthening the supervision and administration of pharmaceutical excipients. Printed and distributed to you now, please urge the relevant enterprises in the administrative areas to obey, and to do a good job of supervision and inspection.
The state food and drug administration
On August 1, 2012
To strengthen the relevant provisions of the supervision and administration of pharmaceutical excipients
Medicinal materials is an important part of the drug, a direct impact on the quality of the drug. In order to further strengthen the regulation of pharmaceutical excipients production and use, to ensure drug quality and safety, on the basis of the pharmaceutical administration law of the People's Republic of China and its implementing regulations, the state council on strengthening food and product safety supervision and management of special provisions, the drug supervision and administration of production
Method ", "drug registration management approach", "drug production quality management norms" and other relevant laws and regulations, special regulations are as follows:
A, medicine preparation production enterprise must guarantee the quality of purchased pharmaceutical excipients
(a) drug preparation production enterprise is responsible to drug quality. Must strengthen the management of pharmaceutical production quality, to ensure drug quality and safety. Must be strictly management of pharmaceutical excipients used, according to the approved by the drug regulatory agency of the prescription craft, use drug meets the requirements of pharmaceutical excipients production. In drug quality problems caused by illegal use of pharmaceutical excipients, pharmaceutical preparations production enterprises must bear the main responsibility.
(2) drug preparation production enterprises must improve the quality management system. Shall ensure that quality management department quality assurance and quality control duties effectively, enterprises and other departments, head of the personnel shall not disrupt or interfere with the quality control departments perform their duties. Supplier shall conduct audit and medicinal material was determined by the quality management department for approval.
(3) the drug preparation production enterprises should strengthen the medicinal supplementary material supplier audit. Should according to "drug production quality management standard (revised in 2010)" the relevant requirements, quality assessment on a regular basis to the pharmaceutical excipients production enterprise, the quality of pharmaceutical excipients production enterprise quality system audit and review, and establishing all buy pharmaceutical excipients and vendor quality files.
(4) drug preparation production enterprises shall strictly control the quality of the pharmaceutical excipients used. Every purchase of pharmaceutical excipients, must according to quality standards approved by the drug registration approval test, to ensure that conform to the requirements for medicinal use. For the national drug standards issued by pharmaceutical excipients, must conform to the requirements of the national drug standards.
(5) drug preparation production enterprises should sign quality agreement with main medicinal material suppliers. At any time to master the situation of pharmaceutical excipients, used to study and evaluate the effects of changes of drug quality, and in accordance with the requirements of the "drug registration management approach" to declare.
Second, the pharmaceutical excipients production enterprise must ensure that the quality of the products
(6) pharmaceutical excipients production enterprises must be responsible for the product quality. Should strictly carry out the quality control standard for pharmaceutical excipients production, improve the enterprise quality management system, strengthen the supplier audit on raw materials used in production, strict raw material quality control, organize production according to the prescription of approved by the product registration process, specification product batch number, to ensure product quality stability. For approval has been obtained and the historical use of pharmaceutical excipients, should according to deal with the quality of the pharmaceutical preparations production enterprise contract organization production.
(7) pharmaceutical excipients production enterprises must ensure the quality of products. Should be according to the approved by the registered or and drug production enterprise quality standards agreed in the contract, all items of inspection for each batch of products, qualified rear can put in storage, and marketing. For the national drug standards issued by pharmaceutical excipients, must comply with the relevant requirements of the national drug standards. Before the product release, all production documents and records, including the test data shall be review by the quality management department and meets the requirements, shall not release the factory does not comply with the requirements.
(eight) pharmaceutical excipients production enterprises should cooperate with drug preparation production enterprises to carry out the supplier audit. In case of production process, source of raw materials, such as the changes may affect the quality of medicinal materials, should be active in the corresponding assessment, timely notify the drug preparation production enterprises.
Three, the pharmaceutical supervisory and administrative department to implement classified management for medicinal materials
(9) pharmaceutical excipients implement classified management. For new pharmaceutical excipients and security risks of higher pharmaceutical excipients license management, namely the production enterprise shall obtain the pharmaceutical production license, varieties must be registered permission; Implements the record management on other materials, namely, production enterprises and their products for the record. The license management varieties catalogue shall be formulated by the state food and drug administration organization, released in batches.