Article 60 The quality management organization is responsible for the quality management of the whole process of preparation. Its main responsibilities:
(1) to develop quality management organization tasks, duties;
(2) to decide whether the materials and intermediates can be used;
(3) study and deal with major quality problems of preparations;
(4) preparation after passing the test, the person in charge of the quality management organization to review the whole process of preparation records and decide whether to issue for use;
(5) review of defects and review of the whole process of quality management;
(6) the quality management organization is responsible for the quality management of medical institutions and medical institutions. >(v) review the handling procedures for nonconforming products and supervise the implementation.
Article 61 The Pharmaceutical Inspection Office is responsible for the inspection of the whole process of preparation. Its main duties:
(1) to develop and revise the materials, intermediate products and finished products of internal control standards and inspection procedures, the development of sampling and sampling system;
(2) the development of test equipment, instruments, reagents, reagent, reagent solution, standards (or reference), titrant and culture medium and experimental animals and other management;
(3) materials, intermediate products and finished products to carry out Sampling, inspection, sample retention, and issue inspection reports;
(d) monitoring the number of microorganisms and dust particles in the clean room (area);
(e) evaluation of raw materials, intermediates and finished products of the stability of the quality of the data for the determination of the storage period of the material and the expiration date of the preparation;
(f) the development of the duties of the personnel of the Pharmaceutical Inspection Office.
Article 62 The quality management organization of the preparations of medical institutions shall regularly organize self-inspection. Self-inspection shall be conducted in accordance with a predetermined procedure and in accordance with the prescribed contents to confirm the consistency with these norms.
Self-inspection should be recorded and written self-inspection report, including evaluation and improvement measures.