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Current position:Home >> Products >> The provisions of the stateProducts

To strengthen the relevant provisions of the supervision and administration of pharmaceutical excipients

PubDate:2014/5/12 9:33:09   Category:Products > The provisions of the state [Print][Close]

On August 1, 2012, the state food and drug administration issued by the relevant provisions of strengthening the supervision and administration of pharmaceutical excipients. The "rules" drug preparation production enterprise must guarantee the quality of purchased pharmaceutical excipients; Pharmaceutical excipients production enterprise must ensure that the quality of the products; Pharmaceutical supervisory and administrative department to implement classified management for pharmaceutical excipients; Pharmaceutical supervisory and administrative departments must strengthen the supervision of pharmaceutical excipients production process using; Pay attention to basic data construction, establish the good faith management mechanism part 5, since February 1, 2013.

directory

1 the state food and drug administration

2 To strengthen the relevant provisions of the supervision and administration of pharmaceutical excipients

1 the state food and drug administration

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 drug safety office [2012] no. 212

Various 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

2 To strengthen the relevant provisions of the supervision and administration of pharmaceutical exMedicinal materials is an important part of the drug, directly affect 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, such as ", "drug supervision and administration of production method", "drug registration management method", "drug production quality management norms" and other relevant laws and regulations, special regulations are as follows:

1medicine preparation production enterprise must guarantee the quality of purchased pharmaceutical excipients

     1Drug preparation production enterprise is drug quality responsibility. Must strengthen the management of pharmaceutical production quality, to ensure drug quality and safety. Must be strictly management of pharmaceutical excipients used, according to prescription craft, approved by the pharmaceutical supervisory and administrative department to use drug meets the requirements of pharmaceutical excipients production. Illegal use of pharmaceutical excipients from drug quality problems, drug preparation production enterprises must bear the main responsibility.

     2Drug 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 management department to perform his duties. Supplier shall conduct audit and medicinal material was determined by the quality management department for approval.

     3Drug 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, quality of pharmaceutical excipients production enterprise quality system audit and review analysis, and establish all buy pharmaceutical excipients and vendor quality files.

4Drug preparation production enterprises shall strictly control the quality of the pharmaceutical excipients used. Every purchase pharmaceutical excipients, must according to quality standards approved by the drug registration approval test, to ensure that conform to the requirements for medicinal. For the national drug standards issued by pharmaceutical excipients, must conform to the requirements of the national drug standards.

5Pharmaceutical preparations production enterprise should with main medicinal material supplier quality agreement. 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 approachto declare.

2Medicinal materials production enterprises must ensure that the quality of the products

6Medicinal materials 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 the contract and drug preparation production enterprises organize production quality agreement.

7Medicinal materials 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.

8Medicinal materials 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 drug preparation production enterprises.

3Pharmaceutical supervisory and administrative departments implement classified management for medicinal materials

9Pharmaceutical 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; For other accessories a filing management, that is, 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.

 The licensing management of pharmaceutical excipients, production enterprise shall submit relevant materials as required. By the pharmaceutical supervisory and administrative departments at the provincial level in accordance with the requirements of the quality control standard for pharmaceutical excipients production for production site inspection, the dynamic sampling test, and after qualified by the state food and drug administration to be registered. The state food and drug administration of complementary makings registration audit should be associated with corresponding pharmaceutical preparations.

Pharmaceutical excipients on the management of implementation for the record, by the production enterprise to submit relevant information, submitted to the local pharmaceutical supervisory and administrative departments at the provincial level for the record. Pharmaceutical supervisory and administrative departments at the provincial level may, when necessary, conduct site inspection and sampling inspection.

The requirements of the relevant pharmaceutical excipients permission and registration shall be formulated separately. Import of medicinal materials with reference to the regulations, submitted to the state food and drug administration approval or for the record.

10Strict drug registration filing requirements for pharmaceutical excipients. Pharmaceutical preparations of production enterprises to declare the drug registration, it shall submit the pharmaceutical excipients used type, supplier, quality standard and supplier audit results and data; Pharmaceutical excipients kinds of the supplement of the change, should carry on the corresponding research, submit a research materials and supplier audit results, submitted to the state food and drug administration approval rear can use. On without changing materials species only changes its suppliers shall submit the relevant research materials and supplier audit results, can be used only to the pharmaceutical supervisory and administrative departments at the provincial level for the record.

11Strengthen the management of pharmaceutical excipients standard. National pharmacopoeia committee, the state food and drug administration group pharmaceutical excipients quality standard system revision work, release pharmaceutical excipients national drug standards, research to develop pharmaceutical excipients recommendation. Pharmaceutical supervisory and administrative departments at all levels in accordance with the national drug standard for the supervision and inspection.

4Pharmaceutical supervisory and administrative departments must strengthen the supervision of pharmaceutical excipients production use

12Local pharmaceutical supervisory and administrative departments at all levels shall implement the supervision responsibility. To strengthen drug preparation production enterprises within their respective administrative areas daily regulation, focusing on whether pharmaceutical preparations production enterprises according to the approved process prescription; Whether on medicinal materials production enterprises according to the requirement of the supplier audit to audit; Whether according to the requirements of the pharmaceutical excipients used inspection according to the relevant quality standards; Whether changes without approval pharmaceutical excipients; Supplier change whether the record in accordance with requirements, etc.

13The local pharmaceutical supervisory and administrative departments at all levels should strengthen the supervision of medicinal materials production. Medicinal materials production enterprises within their respective administrative areas to carry out the daily supervision, or according to the drug preparation found problems in the supervision and inspection of production enterprises, extended check on medicinal materials production enterprises. Review the production of medicinal materials in compliance with the quality control standard for pharmaceutical excipients production; Whether strict control of raw material quality. Whether or not carried out in accordance with the approved or registered technology production; Whether to establish a perfect batch management system and inspection system. To not accept check, drug preparation production enterprise shall use its production of pharmaceutical excipients.

14Pharmaceutical supervisory and administrative departments at all levels should strengthen the supervision of pharmaceutical excipients to sample. According to the supervision and inspection of the condition, clear and oversee focus, refinement of proper scope and requirements. Sample range shall cover pharmaceutical excipients production enterprises and pharmaceutical preparation manufacturing enterprises such as pharmaceutical excipients used units. For supervision and inspection and found problems in the sample of the enterprises and institutions, to increase the intensity of sample frequency and inspection.

15The pharmaceutical supervisory and administrative departments at various levels shall increase the investigation dynamics. Found drug preparation production enterprises, pharmaceutical excipients production enterprises in respect of medicinal materials production, using illegal, should by the pharmaceutical administration law of the People's Republic of China, the state council on strengthening food and product safety supervision and management of special provisions "and other relevant provisions of the relevant enterprises and those responsible for investigation, if the circumstances are serious, shall be given heavier processing strictly in accordance with the law. If the case constitutes a crime, transferred to public security organs, shall be investigated for criminal responsibility according to law.

5Pay attention to basic data construction, establish credit management mechanism

16Pharmaceutical excipients databases. Drug preparation production enterprise shall be approved according to the pharmaceutical supervisory and administrative department of pharmaceutical excipients usage, fill in the use of information products of pharmaceutical excipients, and notify and assist pharmaceutical excipients production enterprise fill in pharmaceutical excipients production information, submitted to the respective local pharmaceutical supervisory and administrative departments at the provincial level. The state food and drug administration and the pharmaceutical supervisory and administrative departments at the provincial level summary information, establishing database of pharmaceutical excipients, comprehensive grasp the dynamic situation of medicinal materials production and use.

17Establish credit files of medicinal materials production enterprises. The pharmaceutical supervisory and administrative departments at the provincial level shall establish pharmaceutical excipients production enterprise credit files, open of proper inspection, the condition of medicinal materials production enterprises, reference for drug preparations when choosing medicinal materials production enterprises.

18Encourage the public to participate in the supervision and administration. Support industry association, the third party and the public on medicinal materials production using the violation behavior in the process of monitoring and reporting, jointly safeguard the quality and safety of drugs and pharmaceutical excipients. The relevant industry association shall strengthen industry self-discipline, promote the good faith construction industry, promote the classification management, guide pharmaceutical production preparation and pharmaceutical excipients production enterprises integrity of law-abiding, operating in accordance with the law.

 

These provisions by the state food and drug administration shall be responsible for the interpretation, since February 1, 2013.

 

 

 

 

 

 

 

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