Medical network - May 19 December 21, the CFDA website business consistency evaluation production site inspection four guiding principles such as draft, and on January 20, for the end of the comment. On May 18, the CFDA website issued a "quality of generic drugs and curative effect evaluation and guiding principles to develop the inspection consistency of the quality of generic drugs and curative effect evaluation consistency production site inspection guidelines" the quality of generic drugs and curative effect evaluation of clinical trial data consistency check guiding principles "the quality of generic drugs and curative effect evaluation have guiding principles for checking consistency of a formal draft. 

 

The quality of generic drugs and the consistent evaluation of the effectiveness of curative effect were evaluated by the inspection guiding principle 

 

For the implementation of the general office of the state council about the opinions of the consistency to carry out the quality of generic drugs and curative effect evaluation "(countries do hair [2016] no. 8), and further standardize the quality of generic drugs and curative effect evaluation (hereinafter referred to as the consistency evaluation) consistency for inspection requirement, ensure the quality of drug inspection, these guidelines are formulated. 

 

One purpose 

 

The inspection is a specific examination of the problems, questions, and complaints that have been found in the work of conformance evaluation. 

 

Second, organization 

 

(1) the state food and drug administration shall be responsible for the overall coordination and supervision and administration of the nationwide conformance assessment. 

 

(2) the administration of state food and drug supervision and administration of the food and drug audit inspection center (hereinafter referred to as the inspection center) to be responsible for guiding the national consistency evaluation field inspection work, is responsible for organizing the implementation of national and overseas for inspection; The supervision and administration of the state administration of food and drug administration has been carried out by inspection organizations for inspection. 

 

(3) the provincial food and drug supervision and administration department shall be responsible for the organization to accept the development of domestic generics site, production site, clinical trial carried out for inspection; The administrative areas of the state administration of food and drug administration, or the inspection center, shall be examined for inspection. 

 

Procedures and requirements 

 

(1) program 

 

The office of the department of pharmaceutical supervision and administration may initiate a check on the following circumstances: 

 

(1) the problems found in the evaluation of the conformance evaluation; 

 

(2) conformance evaluation and related reporting problems related to drug registration; 

 

(3) the pharmaceutical supervisory and administrative department or the conformance evaluation office considers the other circumstances required for verification. 

 

The inspection agencies shall be responsible for the examination of the risks of the inspection tasks and the timely organization of the inspection. The inspection team shall be composed of two or more inspectors, and shall be equipped with sufficient inspectors with relevant professional experience for the tasks examined. 

 

The inspection may be carried out in advance notice or in a manner not told, but also in the form of flight inspection. 

 

At the time of necessity, the sample will be drawn from the site to review the inspection agency designated by the office. 

 

The inspection of the cause of the initiation may be carried out for examination, and the necessary extension inspection may be carried out without the inspection of the comprehensive system. 

 

(2) basic requirements 

 

The unit that is inspected should cooperate with the inspection, and the inspection unit shall be deemed to refuse or evade inspection in any of the following circumstances: 

 

(1) to delay, limit, and refuse to inspect personnel into the place of examination or area, or limit the inspection time; 

 

(2) not providing or delaying the provision of materials such as documents, records, bills, vouchers, electronic data, etc. 

 

(3) to cheat, mislead or evade the inspection by means of not being able to claim the staff's absence or deliberately stop the production and operation; 

 

(4) refusing or restricting the work of photographing, duplicating, sampling, etc.; 

 

(5) other circumstances that do not cooperate with the inspection. 

 

The examination group shall make a written record of the refusal of the inspected unit to avoid the inspection, and shall be ordered to make corrections and promptly report the dispatched units. If the person who has been ordered to correct the situation remains uncorrected and cannot complete the inspection, the conclusion shall be deemed to be inconsistent. 

 

2. Have a local agency for inspection, inspectors and other related personnel shall check flight information, whistleblower information, such as by examination unit business secret information confidential. 

 

Four, result decision 

 

Have for inspection should be around "because", carried out with reference to the evaluation and guiding principles to develop the inspection consistency "consistency evaluation production site inspection guidelines" inspection guiding principles of clinical trial data consistency evaluation of corresponding check points and determination principle. 

 

If the conclusion of examination is "not through", the corresponding inspection conclusion should be deemed "not passed".