1, level
Drug Administration
The full name of the State Food and Drug Administration, is the State Council comprehensive supervision and management of pharmaceuticals, medical devices, cosmetics, health food and food safety in the catering sector of the directly under the organization.
Pharmaceutical Inspection Institute
It is a secondary organization under the FDA.
2. Functions
Drug Administration
Responsible for drafting draft laws and regulations for the supervision and management of food (including food additives, health food) safety, drugs (including traditional Chinese medicines and ethnic medicines), medical devices and cosmetics,
Developing the implementation of administrative licensing of food products and supervising their implementation, and organizing the development and promulgation of the National Pharmacopoeia, such as pharmaceuticals and medical devices standards, Classification management system and supervise the implementation,
Develop the food, drugs, medical devices, cosmetics supervision and management of the inspection system and organize the implementation of the organization to investigate and deal with major violations.
Pharmaceutical Inspection Institute
As a technical support organization of the Drug Administration, medical device testing, food and drug safety supervision and inspection. In order to cooperate with the national adjustment of the functions of the drug supervision and management department, nowadays each drug testing center is constantly expanding the parameters of the projects covered by the functions of food (including health food), cosmetics, pharmaceutical packages and other items.
Expanded
Pharmaceutical inspection quality assurance system
1, the drug testing center should establish a quality assurance system, which involves the following aspects:
(1) testing process quality assurance (such as acceptance of the inspection procedures, test bases and the implementation of the standard operating procedures, records and reports of the writing, checking, Audit, processing of test data, the issuance of reports, etc.);
(2) testing environment and instrumentation quality assurance;
(3) standard substances and laboratory animals, laboratory reagents, quality assurance;
(4) test personnel technical quality assurance.
The quality assurance system should have a clear hierarchical responsibility system to ensure the quality of the whole process of drug testing work to ensure that drug testing, new drug review, standard review, scientific research results and other reports of the accuracy and reliability of the report.
2, in order to check, supervise the implementation of the quality assurance system, drug testing laboratories should be set up quality assurance supervision and inspection (hereinafter referred to as quality assurance inspectors). Quality assurance inspectors should have many years of experience in drug testing laboratories, with intermediate or higher technical title, appointed by the director, work independently, directly responsible for the director.
3, quality assurance inspectors should be received, inspection, laboratory records, failed drugs or test results in suspicious situations in the re-examination and processing, laboratory facilities and equipment, scientific research and other supervision.
4, quality assurance inspectors should formulate an annual plan; regular or irregular inspection of the relevant departments of the implementation of the quality assurance system; write a record of the inspection, including the date, purpose, content, implementation, recommendations and comments, the name of the inspector. Discover major problems and report them in time?
Source of reference? Baidu Encyclopedia Pharmaceutical Inspection Center
Reference source? Baidu Encyclopedia? State Food and Drug Administration