To apply to the provincial drug supervision department.
2, this standard is set to assess the provisions *** 93. Which set the veto clause 5 (article number before the "**"); focus on 17 articles (article number before the "*"), each full 10 points; general provisions of 71 articles, each full 5 points.
3. The scoring coefficients for each article are determined by the degree of achievement of the requirements of the article. Scoring coefficients of the provisions of the following:
1) to meet the requirements of the coefficient of 1;
② basic to meet the requirements of the coefficient of 0.6;
3) to meet the requirements of the coefficient of 0.
4, acceptance assessment, according to the category of the preparation to determine the specific inspection items. Negative terms qualified, and scoring terms of the total score rate of not less than 60% is qualified.
Part II Inspection and Evaluation Items
I. Personnel and Institutions:
1, the medical institution should have a quality management organization consisting of the dean in charge, the Department of Pharmacy (Pharmacy, Pharmacy Bureau) and the heads of the relevant departments such as the preparation room and the Pharmaceutical Inspection Office.
2, the preparation room of the medical institution should be directly under the leadership of the pharmacy department, including the preparation and inspection of two parts.
** 3, the person in charge of preparation and drug testing should have a college degree or above in pharmacy (or have the technical title of pharmacist in charge or above), familiar with the drug management regulations, with preparation and quality management capabilities and is responsible for the quality of the preparation.
* 4, the preparation room of medical institutions engaged in the preparation of technical work should have a pharmacist or secondary school pharmacy education, other personnel should have a high school education and training and licensing. The proportion of pharmacy technicians shall not be less than 50% of the total number of preparation personnel.
5, sterilized preparations, general preparations and Chinese medicine preparations should be equipped with the appropriate professional pharmacy technicians.
6, the drug testing room inspectors should be pharmacists or college pharmacy degree or above, and to maintain a relatively stable technical staff.
7, engaged in the work of light inspection of the naked eye vision should be more than 0.9, without color blindness.
8, preparations and drug testing responsible for the change should be reported to the local food and drug supervision and management department within 30 days for the record.
9, should develop an annual personnel training program, all types of personnel for "Drug Administration Law" and technical training, at least one assessment per year, and assessment records for storage.
Second, plant and facilities:
10, the environment around the preparation room must ensure that the quality of the preparation requirements, within 30 meters from the preparation room shall not have public toilets, boiler rooms, mortuaries, infectious disease rooms, animal houses and other sources of pollution, within 10 meters shall not have exposed land surface, the external environment should be kept clean.
11, the preparation of indoor walls, ceilings, floors should be smooth, clean, no shedding and gaps, should be resistant to cleaning and disinfection.
12, the preparation room should have and preparation requirements corresponding to the lighting, room temperature regulation, ventilation and "five preventive" (dust, pollution, mosquitoes and flies, rodents, foreign objects) facilities.
13, the preparation room of the house and area must be prepared with the preparation of varieties of requirements, according to the preparation process, reasonable layout, people, logistics separate, general and clean areas separate, internal and external preparations separate preparations, aseptic preparations separated from other preparations, offices, lounges, and preparation rooms separate.
14, all kinds of preparations should be set up according to the different needs of different operating rooms, each dosage form according to the process of division of operating positions, into the clean area should be provided with a dressing, secondary dressing and hand washing, disinfection and other facilities.
15, according to the preparation process requirements, the clean room should be divided into levels of air cleanliness, the number of microorganisms and the number of dust particles should be in line with the provisions of the regular testing and recording.
** 16, the preparation of large-capacity injections of key positions should meet the requirements of the clean level, filling and sealing positions should be 100 levels of cleanliness, dilute distribution, filtering and direct contact with the final processing of packaging materials of the drug post for the 10,000 level, concentrated, weighing,
dosing positions should be 100,000 levels.
17, before preparation, the main operating bench in the preparation room must be cleaned, disinfected or sterilized by physical or chemical methods. May not use ordinary window air conditioners, electric fans to send exhaust.
18, the preparation of the preparation positions should be moisture-proof, dust removal measures, the ground should be free of stagnant water.
* 19, pre-treatment of Chinese herbal medicine, extraction, concentration, etc. must be strictly separated from its subsequent processes, screening, slicing, crushing and other operations should be effective dust removal, exhaust facilities.
20, clean room piping, lamps, air and other utilities in the design and installation should be avoided in parts that are not easy to clean.
21, the clean room should be sufficient lighting, the main workplace illumination should be 300 lux (lx).
22, the clean room temperature should be controlled at 18-26 ℃, relative humidity should be controlled at 45-65% (except for special requirements of the process).
23, clean room windows, technical mezzanine and into the interior of the pipeline, air, lamps and lanterns and walls or canopy connection parts should be sealed. The static pressure difference between neighboring rooms with different air cleanliness levels should be more than 5 Pa, and the static pressure difference between the clean room (area) and the outdoor atmosphere should be more than 10 Pa, and a certain percentage of fresh air should be sent in.
24, clean room installation of pools, floor drains should be suitable for the location, shall not be contaminated with preparations. 100 level (excluding local 100 level) shall not be set up in the clean area of floor drains.
25, the preparation room should have with the preparation of the corresponding raw materials, packaging materials, finished products, such as storage, ventilation should be good, all kinds of materials shall not be stacked in the open.
26, the use of drug testing room area and facilities should be carried out with its inspection tasks.
Third, equipment:
27, the preparation room should have with the preparation of dosage forms and varieties appropriate to meet the quality requirements of the preparation of equipment, scales, gauges, etc., internal and external preparations should be separated from the appliances used.
28, equipment selection, installation should be consistent with the preparation requirements, easy to clean, disinfect or sterilize, to facilitate the preparation of the operation and maintenance, maintenance, and can prevent errors and reduce pollution.
29, and drugs in direct contact with the surface of the equipment should be clean, smooth, easy to clean or disinfect, corrosion resistance, no chemical changes with drugs and adsorption of drugs. Lubricants, coolants, etc. used in the equipment shall not cause contamination of drugs or containers.
** 30, the preparation of large-capacity injections used for injection water, must be prepared using multi-effect distilled water apparatus, and in line with the Chinese Pharmacopoeia standards.
31, large-volume injection sterilization facilities should be used double casement sterilization cabinet.
32, the preparation, storage and distribution of water for injection should be able to prevent the growth of microorganisms and contamination. Used as a preparation of large-capacity injections of water for injection, storage tanks need to be stored when the ventilation holes should be installed not to shed fibers of hydrophobic sterilizing filter, storage should be used to 80 ° C or more insulation, 65 ° C or more insulation cycle or 4 ° C or less storage.
* 33, drug testing room should be equipped with testing instruments and equipment appropriate to the variety of preparation.
34, for the preparation and testing of instruments, meters, gauges, scales, etc., its scope of application and precision should be in line with the requirements of preparation and testing, there should be a clear sign of conformity, and regular calibration.
35, the equipment used should have management rules and regulations and operating procedures, and in a prominent position in the equipment has a status mark.
36, the equipment should be managed by a person, repair, maintenance, use of records, instruments and equipment to establish a file.
Fourth, materials:
* 37, the preparation of raw materials should be in accordance with the statutory pharmaceutical quality standards, purchased from legal production units, with the approval number and production batch number, and used within the validity period.
38, excipients and packaging materials should be tested according to the regulations and used only after meeting the standards; excipients for internal preparations should meet the standards for medicinal and edible use.
39, the Chinese herbal medicines used in the preparations shall be purchased according to the quality standard, and reasonably stored and kept.
* 40, there is no medicinal standard of special raw materials should be tested for safety and other tests and approved by the provincial food and drug supervision and management department before use.
41, a variety of materials should be strictly managed, qualified materials, materials to be tested and unqualified materials should be stored separately, and easy to identify the obvious signs. Unqualified materials, should be dealt with in a timely manner in accordance with relevant regulations.
42, a variety of materials should be reasonably stored according to its performance and use, there are special requirements should be stored in accordance with the specified conditions, volatile materials or flammable solvents should be stored in a safe place to avoid contamination of other materials or cause combustion.
* 43, narcotic drugs, psychotropic drugs, toxic drugs for medical use, and flammable, explosive and other dangerous goods storage, storage, should be strictly enforced the relevant provisions of the state.
44, the material should be stored according to the specified period, the storage period should be timely re-examination of any special circumstances.
* 45, the preparation of labels, instructions for use must be consistent with the food and drug supervision and management department approved the content, style, text, and shall not be changed.
46, the preparation of the label, instructions for use should be according to the variety, specifications, special library (cabinet) storage, custody, according to the actual needs of the amount claimed; labeling in and out of the warehouse, the destruction of records should be made, and shall not be lost.
V. Health:
47, the preparation room should develop a health management system; and measures to prevent contamination, by a person in charge.
48, the preparation room shall not store personal belongings and sundries unrelated to the preparation. The waste in the preparation should be disposed of in time.
49, locker room, bathroom and toilet facilities shall not adversely affect the clean room (area).
50, the preparation room and preparation equipment, containers, etc. should be clean procedures, including: cleaning methods, procedures, intervals, the use of detergents or disinfectants, cleaning tools, cleaning methods and storage location.
51, the clean room should be regularly disinfected, the use of disinfectants shall not be contaminated equipment, materials and finished products. Disinfectant varieties should be regularly replaced to prevent the production of drug-resistant strains.
52, the selection of materials, styles and wear work clothes should be prepared with the operation and clean room level requirements, and shall not be mixed wear. Cleanroom work clothes should be smooth texture, do not produce static electricity, do not shed fibers and particulate matter. Sterile overalls must cover all hair, beard and feet, and can retain human shedding.
53, different clean level room use of work clothes (shoes, hats, masks) should be regularly cleaned, organized, disinfected or sterilized when necessary. Washing should not bring additional particulate matter.
54, in the preparation of infusion of clean areas used in the work clothes (shoes, hats, masks) should be set up in the preparation room special laundry equipment and cleaning, finishing, disinfection or sterilization.
55, the clean room is limited to the preparation of the room and approved personnel to enter.
56, the preparation of personnel shall not make-up and wear jewelry, not bare hands in direct contact with drugs.
* 57, the preparation personnel should have a health file and physical examination at least once a year. Infectious diseases, skin diseases and wounds on the body surface shall not be engaged in the preparation and dispensing of preparations.
VI. Preparation management:
58, should be the preparation room facilities and equipment, preparation prescription, process, quality control methods for validation of the validity of all validation records should be archived and preserved.
59, validation documents should include validation programs, validation records, validation reports, evaluations and comments, and approvers.
** 60, the preparation of preparations must have a prescription, preparation protocols and standard operating procedures. The above documents must be revised in accordance with the prescribed procedures for approval, and shall not be changed arbitrarily.
61, each batch of preparations should be checked according to the material balance of the input and output, if there is a difference must be identified before the normal procedures.
62, each batch of preparation should be prepared to prepare the batch number, and indicate the date of preparation, storage conditions; expiration date of the drug should be marked.
* 63, the preparation of water must comply with the provisions of the Chinese Pharmacopoeia standards; ordinary preparations should be prepared using purified water, sterile preparations should be prepared using water for injection.
64, the water quality of purified water, water for injection should be regularly in accordance with the provisions of the Chinese Pharmacopoeia for full inspection, each inspection should be a detailed record.
65, after each preparation should be cleared, and there should be clear records. Before each preparation, it should be confirmed that there is no leftover from last time before preparation.
* 66, the preparation of different preparations (including different specifications of the same preparation) shall not be carried out simultaneously in the same preparation room.
67, the preparation process should be avoided weighing, sieving, crushing and other cross-contamination that may cause dust dispersion.
68, the containers and equipments used in the process of preparation need to have eye-catching status symbols, which should indicate the name of the material, batch number and quantity, etc.
* 69, the preparation process should be avoided.
* 69, the preparation of preparations containing narcotic drugs, toxic drugs for medical use, psychotropic substances should be strictly enforced.
* 70, the preparation of preparations for direct contact with the drug packaging materials must meet the requirements of quality standards.
** 71, infusion bottles, glue plugs and other packaging materials in direct contact with drugs shall not be reused. No outsourcing of soft-packaged infusion bags for large-capacity injection filling.
* 72, each batch of preparations should be able to reflect the preparation of a complete record of all aspects. Operators should fill in the records in a timely manner, the records should be clear, true, complete data, and signed by the operator, reviewer and clearer.
73, the record shall be kept neat and clean, shall not be torn and arbitrarily altered, need to be altered, the person who changes shall sign at the change and make the altered part recognizable. Preparation records should be completely filed and kept for at least one year.
74, the preparation room should be equipped with necessary tools, such as pharmacopoeia, hospital preparation specifications, preparation notes, preparation, drug testing, etc..
VII, quality management:
* 75, the quality management organization of the preparation of medical institutions and the pharmacy is responsible for the whole process of quality management and inspection of preparations, preparations after passing the inspection, the quality management organization to review the whole process of preparation of preparations, decide whether to issue for use.
76, the drug testing room should be set up according to the size and variety of preparations, chemical, biological, instrumentation, such as testing rooms and sampling observation room. Preparations of small size can be combined as appropriate, and should meet the needs of the inspection work.
77, the drug testing room when necessary to develop intermediate preparations, finished product testing procedures, the establishment of sampling, sampling system.
78, drug testing room should be developed for the test equipment, instruments, reagents, reagents, standard, control, titrant, test bacteria, culture media and test animals, etc. Management, and develop the duties of the inspector.
79, the drug testing laboratory should be able to preparations, raw materials, excipients, water quality and other legal standards for testing, testing of prescriptions, secret prescriptions, agreements, etc. should be approved by the Food and Drug Administration method of testing.
80, animal testing laboratories and breeding rooms should meet the requirements of the relevant state regulations.
81, the preparation of finished products should be tested according to regulations. There must be a complete inspection of the original records and all batch numbers of preparation inspection report
sheet. Inspection records should be standardized writing, handwriting should be clear, if there is a change should be signed by the person who changed the signature and the inspector, the reviewer's signature, the original records should be retained for one year. Preparation of finished product inspection report form should be signed by the inspector, the person in charge.
82, the preparation according to the quality standard test, before being used in the clinic.
The preparation label must be printed clearly, should indicate the name, approval number, specifications, content, batch number, indications, dosage, contraindications, precautions, storage requirements, expiration date, internal, external, ophthalmic and so on. Signs of preparations for different purposes should be obvious. Labeling can not accommodate should be accompanied by instructions for use.
* 83, the preparation of finished products must be issued before the preparation records, quality control records and other audits. Without qualified inspection and quality management organization responsible for the approval shall not be issued for use.
84, should be based on the characteristics of the formulated varieties of the specified period of use.
VIII. Other:
85, the use of preparations found in the process of quality problems, adverse reactions should be recorded in accordance with the relevant provisions, fill in the form to report to the drug supervision and management departments, and retain the case and the relevant tests, inspection reports and other original records for at least one year for inspection.
* 86, the preparation room should be issued by the provincial food and drug supervision and management department of the "preparation license" and declaration documents, acceptance, rectification records.
87, the preparation of varieties of preparations should be declared system, there should be varieties of preparations declaration materials and approval documents.
* 88, the preparation room should establish the necessary management rules and regulations.
89, the preparation room should be prepared preparation procedures, including: the name of the preparation, dosage form, prescription, preparation process and operational requirements, should also include: raw materials, intermediate products, finished products, quality standards and technical parameters and storage precautions, packaging materials (containers) requirements.
90, the preparation room should develop standard operating procedures, the preparation process involved in the unit operation of the specific provisions of the requirements should be met.
91, the preparation process of preparation records should include: number, preparation name, date of preparation, product lot number, the operator of each process, reviewer, cleaner's signature. Equipment related to the operation, the amount of raw materials used in the relevant processes, the number of finished and semi-finished products, the control records of the preparation process and special case handling records.
92, the preparation room should be raw materials, auxiliary materials, semi-finished products, finished products, packaging materials, quality standards and inspection procedures.
93, the preparation of finished products should be quality stability examination records; there should be a batch inspection records.