Legal analysis: record management of preparations and supervision and management of preparation and use. The relevant provisions clearly define the responsibilities of all parties, emphasizing that medical institutions are responsible for the safety, effectiveness and quality of drug preparations, and implement process quality management of formulated preparations, strictly fulfill the responsibility of reporting adverse reactions, and establish an adverse reaction monitoring and risk control system.
Legal basis: "medical institutions preparation supervision and management measures" Article 3 medical institutions preparation supervision and management refers to the (food) drug supervision and management departments in accordance with the law on the preparation of medical institutions preparation conditions and the preparation process, such as review, licensing, supervision and management activities.
Article 4 The State Food and Drug Administration is responsible for the supervision and management of the preparation of medical institutions. Provinces, autonomous regions, municipalities directly under the Central (food) drug supervision and management department is responsible for the supervision and management of the preparation of medical institutions under the jurisdiction.
Article V. Medical institutions shall comply with the "medical institutions preparation preparation quality management standard".
Sixth, medical institutions to prepare preparations, must be able to ensure the quality of the preparation of personnel, facilities, testing equipment, sanitation and management system.
Article VII of the medical institutions to set up a preparation room, should be the location of the province, autonomous region, municipality directly under the Central Government (food) drug supervision and management department to submit the following materials: (a) "Preparation License Application Form for Medical Institutions" (see Appendix 1) (b) implementation of the "Medical Institutions Preparations Preparation Quality Management Specification" self-inspection report; (c) the basic situation of the medical institution and the "medical institutions practice license" copy Copy (d) the location of provinces, autonomous regions and municipalities directly under the Central Health Administration Department of the examination and approval (e) the basic situation of the proposed preparation room, including the scale of investment in the preparation room, covers an area of land, the surrounding environment, infrastructure and other conditions, and to provide the general layout of the medical institutions, the general layout of the preparation room (marked air cleanliness level) preparation room responsible person, the person in charge of the pharmacy inspection room, the preparation quality management Organization responsible for the resume (including name, age, gender, education, major, position, title, years of experience in pharmacy, etc.) and professional and technical personnel accounted for the proportion of the staff of the preparation room, the person in charge of the preparation room, the person in charge of the pharmacy, the person in charge of the preparation quality management organization should be the unit of the working professionals, and the person in charge of the preparation room and the person in charge of the pharmacy shall not be concurrently with each other. (F) the proposed preparation of dosage forms, preparation capacity, varieties, specifications (G) the preparation of dosage forms of process flow charts, quality standards (or draft) (H) the main preparation equipment, testing instruments catalog (I) preparation preparation management, quality management documents catalog.