Medical institutions preparation quality management standard (for trial implementation)

Chapter I General Provisions Article 1 According to the "People's Republic of China *** and the State Drug Administration Law" provisions, with reference to the "Drug Manufacturing Quality Management Code" of the basic principles of the development of this specification. Article 2 The preparation of medical institutions refers to the medical institutions in accordance with the clinical needs of the unit and routinely formulated, self-use of fixed prescription preparations. Article III medical institutions should be prepared to obtain the province, autonomous region, municipality directly under the Central Drug Administration issued the "preparation of medical institutions license". Article IV of the State Drug Administration and the provinces, autonomous regions and municipalities and Drug Administration is responsible for the quality of medical institutions to carry out quality supervision of preparations, and issued a quality announcement. Article V. This specification is a medical institution preparation and quality management of the basic guidelines, applicable to the preparation of the preparation of the whole process. Chapter II institutions and personnel Article 6 The preparation of medical institutions should be set up in the pharmacy department preparation room, pharmacy inspection room and quality management organization. Institutions and positions should be clearly defined responsibilities, and equipped with the appropriate quality and the appropriate number of professional and technical personnel. Article 7 The person in charge of the medical institution is responsible for the implementation of the "norms" and the quality of the preparation. Article 8 The person in charge of the preparation room and drug testing room should have a college degree or above in pharmacy or related professions, with the appropriate management of the practical experience, the ability to make correct judgments and deal with the problems arising from the work.

The persons-in-charge of the preparation room and the drug inspection room shall not be appointed concurrently with each other. Article 9 Personnel engaged in the preparation and operation of preparation and drug testing shall be professionally and technically trained, with basic theoretical knowledge and practical skills.

Where there are special requirements for the preparation of the preparation operation and drug testing personnel should also undergo the appropriate professional and technical training. Article 10 All personnel engaged in the preparation of preparations should be familiar with this specification, and should pass the training and assessment of this specification. Chapter III housing and facilities Article 11 In order to ensure the quality of preparations, the preparation room should be far away from various sources of pollution. The surrounding ground, pavement, vegetation, etc. should not cause pollution of the preparation process. Article 12 The preparation room should have effective facilities to prevent pollution, insects and other animals from entering. Article XIII of the preparation room housing and area must be formulated with the preparation of dosage forms and scale. There should be staff locker room. Article 14 The working room should be reasonably arranged according to the preparation process and air cleanliness level requirements. General and clean area separate; preparation, dispensing and labeling, packaging separate; internal and external preparations separate; sterile preparations and other preparations separate. Article 15 All kinds of preparations should be based on the needs of the dosage form, the process of reasonable convergence, set up different operating rooms, according to the process of division of operating positions. Article 16 The preparation room shall have materials, finished products and other storage rooms suitable for the preparation prepared, and ventilation, moisture and other facilities. Article 17 The pre-treatment, extraction and concentration of Chinese herbal medicines must be strictly separated from their subsequent processes, and there should be effective dust removal and exhaust facilities. Article 18 When designing and constructing the preparation room, consideration shall be given to facilitate the cleaning work when it is in use. Clean room of the internal surface should be flat and smooth, no cracks, interfaces tight, no particles off and can withstand cleaning and disinfection. The junction of the wall and the ground and so on should be curved or take other measures to reduce the accumulation of dust and easy to clean. Article 19 The clean room all kinds of pipeline, lamps and lanterns, air outlet and other utilities in the design and installation should be avoided not easy to clean parts. Article 20 according to the preparation process requirements, divided into air cleanliness level (see annex table Ⅰ, table Ⅱ). Clean room (area) the number of microorganisms in the air and the number of dust particles should be in line with the provisions of the regular testing and recording. Article 21 the clean room (area) should be enough illumination, the main working room of the illumination should be 300 lux. Article 22 the windows of the clean room, technical interlayer and into the indoor pipeline, air outlet, lamps and lanterns and walls or ceiling connection parts should be sealed. Article 23 the clean room (area) should maintain a certain positive pressure, and send in a certain proportion of fresh air. Article 24 clean room (area) installed in the pool, the location of the floor drain should be appropriate, shall not cause pollution to the preparation. 100 clean area shall not be equipped with floor drain. Article 25 The laboratory animal room should be far away from the preparation room. Chapter IV Equipment Article 26 The selection and installation of equipment shall meet the preparation requirements, easy to clean, disinfect or sterilize, easy to operate, repair and maintenance, and can prevent errors and reduce pollution. Article 27 The preparation, storage and distribution of purified water and water for injection shall be able to prevent the growth of microorganisms and pollution. The materials used for storage tanks and delivery pipelines should be non-toxic and corrosion-resistant, and the design and installation of pipelines should avoid dead ends and blind pipes. Article 28 The surface of the equipment in direct contact with drugs should be smooth, level, easy to clean or disinfect, corrosion-resistant; no chemical changes with drugs and adsorption of drugs. The lubricants and coolants used in the equipment shall not cause pollution to the drugs and containers. Article 29 The preparation and testing of preparations should be prepared with the preparation of varieties of equipment, facilities and instruments. Article 30 The instruments, meters, gauges, scales, etc. used for preparation and inspection of the scope of application and precision should be consistent with the preparation and inspection requirements, should be regularly calibrated, and have a qualified mark. Calibration records shall be kept for at least one year. Article 31 establishes rules and regulations for equipment management and formulates standard operation procedures. Equipment should be managed by specialized personnel, regular maintenance, maintenance, and records.