(1998 Revision) Appendix
I. General Provisions
1, the Appendix for the State Drug Administration issued the "Drug Manufacturing Quality Management Standards" (1998 Revision)
Aseptic drugs, non-sterile drugs, raw materials, biological products, radioactive drugs, Chinese medicine preparations and other Supplementary provisions on special requirements for production and quality management.
2, drug production clean room (area) air cleanliness is divided into four levels:
Clean room (area) air cleanliness level table
Cleanliness level Maximum permissible number of dust particles/cubic meter Maximum permissible number of micro-organisms
≥ 0.5 μm ≥ 5 μm Planktonic bacteria/cubic meter Sedimentation of bacteria/petri dishes
100 level 3,500 0 5 1
10,000 level 350,000 2,000 100 3
100,000 level 3,500,000 20,000 500 10
300,000 level 10,500,000 60,000 - 15
3. The management of the clean room (area) needs to Meet the following requirements:
(1) The number of personnel in the clean room (area) should be strictly controlled. Its staff (including maintenance, auxiliary personnel) should be regular health and basic knowledge of microbiology, clean operation and other aspects of training and assessment; into the clean room (area) of the temporary outsiders should be guided and supervised.
(2) clean room (area) and non-clean room (area) must be set up between the buffer facilities, people, logistics toward a reasonable.
(3) 100 clean room (area) shall not be set up in the floor drain, the operator should not operate bare hands, when it is unavoidable, the hands should be disinfected in a timely manner.
(4) 10000 class clean room (area) using the transmission equipment shall not be traversed through the lower level area.
(5) 100000 level above the region of clean work clothes should be washed, dried, organized in the clean room (area), if necessary, should be sterilized as required.
(6) clean room (area) to set the surface of the insulation layer should be flat, smooth, no particulate matter off.
(7) clean room (area) should be used without shedding, easy to clean, easy to disinfect the sanitation tools, sanitation tools should be stored in the product does not cause contamination of the designated location, and should be limited to the use of the region.
(8) clean room (area) in the static conditions to detect the number of dust particles, the number of floating or settling bacteria must comply with the provisions of the dynamic conditions should be regularly monitored under the cleanliness of the situation.
(9) clean room (area) of the purified air such as recycling, effective measures should be taken to avoid contamination and cross-contamination.
(10) air purification system should be cleaned, repair, maintenance and records.
4, the validation of the drug production process must include:
(1) air purification system
(2) process water system
(3) production process and its changes
(4) equipment cleaning
(5) changes in the main raw and auxiliary materials
The validation of the aseptic drug production process should also be Add:
(1) sterilization equipment
(2) liquid filtration and filling (dispensing) system
5, water treatment and its supporting systems should be able to ensure that the water supply to meet the set quality standards of design, installation and maintenance.
6, printed with the same content as the labeling of pharmaceutical packaging, should be managed according to the label.
7, the drug fractional packaging is limited to two lot number for a combined box, the combined box should be marked outside all the lot number, and the establishment of combined box records.
8, drugs should be released by the quality management department before the audit of relevant records, the audit should include: ingredients, weighing process review; each production process inspection records; clear records; intermediate product quality inspection results; deviation processing; finished product inspection results. Meet the requirements and have the auditor's signature before release.
Two, aseptic drugs
Aseptic drugs refers to the statutory drug standards listed in the aseptic inspection program preparations.
1, aseptic drugs production environment air cleanliness level requirements:
(1) the final sterilized drugs:
100 or 10,000 under the supervision of the local 100 level: large-volume injections (≥ 50 ml) of the potting;
10,000 level: diluted injections, filtration; small-volume injections of potting; the final processing of packaging materials in direct contact with the drug. Final processing of packaging materials in direct contact with drugs.
Class 100,000: Dilute dispensing of injectables or dilute dispensing using closed systems.
(2) Non-finally sterilized pharmaceutical products:
Class 100 or local Class 100 in the context of Class 10,000: Preparation of medicinal liquids without decontamination and filtration prior to filling; potting, dispensing, and stoppering of injections; and exposure of packaging materials in direct contact with pharmaceutical products to the environment after their final processing.
Class 10,000: Preparation of pharmaceutical solutions requiring sterilization and filtration prior to filling.
Class 100,000: cap rolling; minimum requirements for final fine washing of packaging materials in direct contact with pharmaceutical products.
(3) Other sterile medicines:
Grade 10,000: Preparation and filling of eye drops for corneal trauma or surgery.
2, sterilization cabinets should have automatic monitoring and recording devices, and their capacity should be compatible with the production batch.
3, liquid contact equipment, containers, piping, valves, pumps, etc. should be used high-quality corrosion-resistant materials, piping installation
Should minimize the connecting (welding) joints. The filter material shall not adsorb liquid components and release foreign matter. Prohibit the use of filter materials containing asbestos.
4, contact with the drug packaging materials shall not be recycled.
5, the principle of division of the batch:
(1) large and small volume injections to the same dispensing tank at a time the preparation of the liquid produced by the homogeneous products for a batch.
(2) powder injection to the same batch of raw materials produced in the same continuous production cycle of homogeneous products as a batch.
(3) lyophilized powder injection to the same batch of liquid using the same lyophilization equipment in the same production cycle for the production of homogeneous products as a batch.
6, direct contact with the drug packaging materials last fine washing water should be consistent with the quality standards for water for injection.
7, measures should be taken to avoid secondary contamination of materials, containers and equipment after the final cleaning.
8, direct contact with pharmaceutical packaging materials, equipment and other items of cleaning, drying, sterilization to the use of time intervals should be specified.
9, the drug solution from preparation to sterilization or sterilization and filtration time interval should be specified.
10, materials, containers, equipment or other items need to enter the sterile work area should be disinfected or sterilized.
11, the finished product of the sterility check must be sterilized according to the cabinet sampling test.
12, raw materials, auxiliary materials should be stored according to species, specifications, batch number, and sampling and testing by batch.
Three, non-sterile drugs
Non-sterile drugs refers to the statutory drug standards are not listed in the aseptic examination of the preparation.
1, non-sterile drugs production environment air cleanliness level of the minimum requirements:
(1) 100,000 level: non-final sterilized oral liquid drug exposure process; deep tissue trauma drugs, ophthalmic drugs, the exposure process; in addition to rectal drugs, the lumen of the drug exposure process.
(2) Class 300,000: Exposure processes for final sterilized oral liquid medications; exposure processes for oral solid medications; exposure processes for topical epidermal medications; and exposure processes for rectal medications.
(3) direct contact with the final handling of packaging materials for pharmaceuticals exposure process cleanliness level should be the same as its pharmaceutical production environment.
2, a large amount of dust produced by the clean room (area) by the capture of dust treatment still can not avoid cross-contamination, its air purification system shall not use the return air.
3, air cleanliness level of the same area, the dust production of large operating room should maintain a relatively negative pressure.
4, the production of sex hormones contraceptive drugs, air purification system of gas emissions should be purified.
5, the production of hormones, antitumor drugs preparation when it is unavoidable to alternate with other drugs using the same equipment and air purification system, should be used for effective protection, cleaning measures and the necessary verification.
6, drying equipment inlet should be filtering devices, air outlet should prevent air backflow device.
7, ointment, ophthalmic ointment, suppository and other preparation and filling of production equipment, piping should be easy to clean and disinfect.
8, the principle of division of the batch:
(1) solid, semi-solid preparations in the molding or dispensing before the use of the same mixing equipment for a mix of homogeneous products produced by a batch.
(2) liquid preparations to fill (seal) before the final mixing of the liquid produced by the homogeneous product as a batch.
9, the production of mold procurement, acceptance, storage, maintenance, issuance and scrap should be formulated accordingly management system, set up a special cabinet for safekeeping.
10, the ink used for direct printing on the drug should meet the requirements of food standards.
11, the production process should avoid the use of fragile, easy to chip, easy to grow moldy appliances; the use of screens should be prevented due to screen breakage and pollution measures.
12, the liquid preparation, filtering, filling and sealing, sterilization and other processes should be completed within the specified time.
13, ointment, ophthalmic ointment, suppository production of intermediate products should be specified storage period and storage conditions.
14, dosage process water and direct contact with pharmaceutical equipment, appliances and packaging materials last washing water should be in line with the purified water quality standards.
Four, API
1, engaged in the production of APIs should be engaged in the production of APIs specific operation of the relevant knowledge training.
2, flammable, explosive, toxic, hazardous substances in the production and storage of plant facilities should be in line with relevant state regulations.
3, API refining, drying, packaging production environment of air cleanliness level requirements:
(1) statutory drug standards listed in the aseptic examination of items of API, the exposure environment should be 10,000 level background local 100 level.
(2) other API production exposure environment is not less than 300,000 level.
4, the quality inspection of intermediate products and the production environment has a cross-influence, its inspection site should not be set up in the production area.
5, API production is appropriate to use closed equipment; closed equipment, piping can be placed outdoors. The use of open equipment or open equipment operation, there should be to avoid contamination measures.
6, it is difficult to accurately separate by batch number of large quantities, large-capacity raw materials, solvents and other materials should be numbered when warehousing; its receipt, issuance,
storage, use should be formulated accordingly management system.
7, the enterprise can be based on process requirements, the characteristics of materials and suppliers of quality system audit, to determine the quality control of materials.
8, materials for special reasons need to deal with the use, there should be an approval process, approved by the person in charge of quality management of the enterprise issued after use.
9, the principle of division of the batch:
(1) continuous production of APIs, produced at certain intervals within the limits of homogeneous products for a batch.
(2) intermittent production of APIs, a certain number of products by the final mix of homogeneous products within the specified time limit for a batch. The product before mixing must be produced according to the same process and meet the quality standards, and traceable records.
10, API production records should be traceable, its batch production records at least from the crude product refining process. Continuous production of batch production records, can be the batch of products in various processes of production operations and quality control records.
11, unqualified intermediate products, should be clearly labeled and shall not be allowed to flow into the next process; for special reasons need to be dealt with the use of, should be handled in accordance with the written procedures and records.
12, replacement of varieties, the equipment must be thoroughly cleaned. In the same equipment for the continuous production of the same variety, such as residues affecting the product, replace the batch, the equipment should also be thoroughly cleaned.
13, difficult to clean specific types of equipment can be dedicated to specific intermediate products, API production or storage.
14, materials, intermediate products and APIs in the plant or plant room flow should be to avoid confusion and contamination measures.
15, sterile API refining process water and direct contact with sterile API packaging materials for the final washing water should be in line with the quality standards for water for injection; other API refining process water should be in line with the quality standards for purification.
16, should be established for fermentation strains custody, use, storage, rejuvenation, screening and other management systems, and records.
17, the packaging containers can be reused, should be cleaned according to written procedures, and remove the original label.
18, API retention package should be the same as the product packaging or the use of analog packaging, stored in conditions consistent with the product labeling instructions, and according to the provisions of the management of the retention of samples for observation.
V. Biological products
1, all personnel engaged in the manufacture of biological products (including cleaning personnel, maintenance personnel) should be based on their production of products and production operations engaged in professional (hygiene, microbiology, etc.) and safety protection training.
2, the person in charge of production and quality management should have the appropriate professional knowledge (bacteriology, virology, biology, molecular biology, biochemistry, immunology, medicine, pharmacy, etc.), and extensive practical experience to ensure that in its production, quality management to fulfill their responsibilities.
3, biological products production environment air cleanliness level requirements:
(1) Class 100: products without sterilization and filtration before filling the preparation, consolidation, filling, freeze-drying, plugging, adding stabilizers, adjuvants, inactivators, etc.;
(2) Class 10,000: products to be sterilized and filtered prior to filling the preparation, consolidation, refining, adding stabilizers, adjuvants, inactivators, etc.;
(2) Class 10,000: products needing sterilization and filtration before filling, preparation, consolidation, refining, adding stabilizers, adjuvants, inactivators, inactivators, etc.
Partitioning of positive serum and antigen-antibody partitioning of in vitro immunodiagnostic reagents;
(3) Class 100,000: consolidation of raw plasma, non-cold temperature extraction, pasteurization prior to partitioning, rolling of lids, and fine washing of final
containers of the products;
orally consumed preparations whose Fermentation culture closed system environment (exposed parts need to be aseptic operation); enzyme-linked immuno
immunosorbent reagent packaging, dispensing, dispensing, drying; colloidal gold reagent, polymerase chain reaction reagent (PCR),
paper slice method reagent, and other in vitro immune reagents; deep tissue trauma with the preparation of the product and a large area of the surface of the body trauma products used in the preparation,
filling.
4, all types of products involved in the production process of high-risk disease-causing factors in the operation, the air purification system and other facilities should also meet the special requirements.
5, the production process using some specific live organisms stage, the requirements of the special equipment, and in isolation or closed system.
6, BCG vaccine production plant and tuberculin production plant must be strictly separated from the production of other products plant, its production equipment to be dedicated.
7, bacillus operation until the completion of the inactivation process must use specialized equipment. Bacillus anthracis, Clostridium botulinum and Clostridium tetani products must be produced in the corresponding specialized facilities.
8. If equipment is dedicated to the production of spore-forming organisms, production should be centralized when processing a product. In a facility or a set of facilities in the staged rotation of the production of bacteriophage products, in the specified time can only produce a product.
9, the production of biological products should pay attention to the plant and facilities of the potential contamination of raw materials, intermediates and finished products.
10, polymerase chain reaction reagents (PCR) production and calibration must be carried out in their own independent buildings to prevent cross-contamination caused by aerosols formed during amplification.
11, the production of human immunodeficiency virus (HIV) and other detection reagents, in the use of positive samples, there must be in line with the corresponding provisions of the protective measures and facilities.
12, production of seed batches and cell banks, should be under the specified storage conditions, special storage, and only allow access to designated personnel.
13, human blood, human plasma or animal organs and tissues as raw materials for the production of products must use special equipment, and strictly separate from the production of other biological products.
14, the use of closed-system biodigester production products can be produced in the same area at the same time, such as monoclonal antibodies and recombinant DNA products.
15, a variety of inactivated vaccines (including recombinant DNA products), toxoids and cell extracts, after their inactivation or disinfection can be used alternately with other sterile products in the same filling room and filling and lyophilization facilities. However, after a product is dispensed, it must be effectively cleaned and sterilized, and the effectiveness of the cleaning and sterilization should be verified periodically.
16, operation of microorganisms with pathogenic effects should be carried out in a special area and maintain a relatively negative pressure.
17, bacterial (toxic) operating area and sterile (toxic) operating area should have their own independent air purification system. Air from the pathogen operation area shall not be recirculated, the air from the risk of more than two types of pathogens should be discharged through the sterilization filter, the performance of the filter should be regularly checked.
18, the use of more than two types of pathogens strong contaminating materials for product production, its discharge of dirt should be effective disinfection facilities.
19, used to process live organisms production operation area and equipment should be easy to clean and remove contamination, can withstand fumigation and disinfection.
20, for the production of biological products, animal room, quality control animal room must be separated from the product production area. Animal feeding management requirements, should be consistent with the provisions of the laboratory animal management.
21, the production of water for injection should be used within 6 people hours after preparation; preparation of 4 hours after sterilization within 72 hours of use, or at 80 ℃ or more insulation, 65 ℃ or more insulation cycle or 4 ℃ or less storage.
22, piping systems, valves and ventilation filters should be easy to clean and sterilization, closed containers (such as fermenters) should be steam sterilization.
23, the production process of contamination of the original body of goods and equipment should be separated from the unused sterilized goods and equipment, and have a clear sign.
24, the main raw materials for the production of biological products (including plasma raw materials for blood products) must meet the quality standards, and by the quality assurance department qualified visa issued.
25. Materials for the production of biological products shall be purchased from legal and quality-assured suppliers, and the suppliers shall be evaluated and sign more fixed supply and demand contracts with them to ensure the stability of the quality of their materials.
26, the use of raw materials of animal origin should be recorded in detail, including at least the source of the animal, animal breeding and feeding conditions, animal health. Animals used for vaccine production should be clean grade or above.
27, the need to establish the production of bacteriophage for the original seed lot, the main generation of seed lot and working seed lot system. Seed lot system should be the original source of bacteriophage species, bacteriophage species characterization, genealogy, bacteriophage species is a single pure microorganisms, production and cultivation characteristics, the most suitable preservation conditions and other complete information.
28, the production of cells need to establish the original cell bank, the main generation of cell bank and working cell bank system, cell bank system should include: the original source of cells (karyotyping, tumorigenicity), the number of population doubling, transmission lineage, whether the cells are a single purified cell line, preparation methods, optimal preservation conditions, etc..
29, production, maintenance, inspection and animal breeding operators, managers, should be vaccinated with the appropriate vaccine and regular physical examination.
30, suffering from infectious diseases, skin diseases, skin wounds and potential adverse effects on the quality of the products are not allowed to enter the production area for operation or quality inspection.
31, the production of biological products in the clean area and the need to disinfect the area, should choose to use more than one type of disinfection, regular rotation, and testing, in order to prevent the emergence of drug-resistant strains of bacteria.
32, at the end of the production operation containing cholera, plague bacteria, HIV, hepatitis B virus and other high-risk pathogens, the suspected contaminated items should be disinfected in situ and individually sterilized before moving out of the work area.
33. During the production day, production personnel shall not go from the area where live microorganisms or animals are operated to the area where other products or microorganisms are operated without clearly defined decontamination measures. Personnel unrelated to the production process should not enter the production control area, and when they must enter, they should wear sterile protective clothing.
34. Personnel engaged in production operations should be separated from animal caretakers.
35, biological products should be produced in strict accordance with the "China Biological Products Regulations" or the process methods approved by the State Drug Administration.
36, the raw materials, stock solutions, semi-finished products and finished products of biological products shall be tested in strict accordance with the "China Biological Products Regulations" or the quality standards approved by the State Drug Administration.
37, the production of biological products should be in accordance with "China's biological products regulations" in the "batch of biological products regulations" batch and prepare the batch number.
38, the national standard for biological products should be prepared by the National Institute for Drug Control, standardization and distribution. Producers can be based on the national standard products standardized preparation of their work product standards.
39, biological products manufacturer quality assurance department should be independent of the production management department, directly under the leadership of the head of the enterprise. Must be able to undertake materials, equipment, quality inspection, sales and adverse reactions to the supervision and management. Production quality management and quality inspection results are in line with the requirements of the products before leaving the factory.
VI, radiopharmaceuticals
1, responsible for the production and quality management of the enterprise responsible for the person in charge of production and quality management, production and quality management of the department responsible for nuclear medicine, nuclear pharmacy expertise and radiopharmaceutical production and quality management experience.
2, engaged in quality inspection personnel should be trained in radiopharmaceutical inspection techniques, and obtain job operation certificate.
3, engaged in the production and operation of personnel should be specialized technical and radiation protection knowledge training, and obtain job operation certificate.
4, the production enterprise shall set up radiation protection management body, its main responsibilities are:
(1) the organization of radiation protection regulations, to carry out radiation protection knowledge of publicity, education and training in the regulations;
(2) responsible for the supervision and inspection of radiation protection work;
(3) timely reporting of radiological accidents to the relevant departments and assist in investigating the treatment of .
5. The plant shall comply with the relevant national regulations on radiation protection and obtain a license to work with radioisotopes.
6, the air cleanliness level requirements of the production environment of radiopharmaceuticals are the same as those in sterile drugs, non-sterile drugs and APIs; the preparation of each component of radioimmunoassay kits should be carried out under the condition of 300,000 levels.
7, the operation of radionuclide workplace floor, workbench should be used to facilitate the decontamination of the material; operation of radioactive iodine and other volatile radionuclides should be carried out in a fume hood, fume hood technical indicators should be in line with the relevant state regulations.
8, containing different nuclides in the production of radiopharmaceuticals must be strictly separated. Radioactive work area should be effectively isolated from non-radioactive work area. Monitoring areas should be set aside around the source of contamination and regularly monitored.
9, the entrance and exit of the production area should be set up to decontaminate the washing and changing facilities, the exit should be set up to detect the radioactive dose.
10, the storage of radioactive substances should be safe, reliable, convenient, with obvious radioactive signs, with fire, theft, leakage prevention and other safety protection facilities, and in line with the requirements of radiation protection.
11, re-use of radioactive substances packaging containers should be a special decontamination treatment site.
12, must have with the production of radiopharmaceuticals and quality control of other appropriate facilities.
13, radionuclides, standard radioactive sources should be stored in special libraries or special cabinets, special custodian, special register.
14, the label should be printed in accordance with the special provisions of radioactive drugs.
15, the outer packaging materials of radioactive drugs should be in line with national regulations on radiation protection.
16, engaged in the production of radioactive drugs, the body surface of personnel, clothing and workplace equipment, walls, floors, surface contamination procedures, should be in line with the relevant state regulations.
17, engaged in the production of radiopharmaceuticals personnel, should be based on the needs of different types of work, equipped with coveralls, work hats, gloves and masks. Class A and B workplaces should also be equipped with work shoes, socks, additional work clothes and other protective equipment. Production personnel working in workplaces that may be contaminated by radioactive gases and vapors should be supplied with high-efficiency masks; under severe contamination conditions, respiratory masks, isolating respirators, air suits and other devices should be supplied as needed.
18, engaged in the production of radiopharmaceuticals before washing the overalls should be tested for radioactive contamination, has been contaminated overalls should be special treatment or radioactive waste disposal.
19. Radioactively contaminated sites should be professionally cleaned up under the supervision of protective personnel and tested before continuing to use.
20. Containers for radioactive waste should be set up in the radioactive work area, and the radioactive waste should be disposed of in accordance with the relevant state regulations.
21, radioactive waste liquids, waste gas discharge should be taken before the corresponding purification and treatment measures, emission standards should be consistent with the relevant state regulations.
22, should be carried out in accordance with the provisions of the General Provisions of the verification work, and increase the effectiveness of radiation protection, fume hood technical indicators, waste gas, waste liquid discharge and other verification work.
23, must establish batch records, including: batch production records, batch packaging records, batch inspection records.
24, must establish the storage of radionuclides, receive, use, return system, and records.
25, must establish a strict radiation protection supervision and inspection system, and have records.
26, must establish radioactive waste liquid, waste gas, solid waste disposal system, and have records.
27, radiopharmaceuticals are divided into internal and external packaging. Outsourcing should be labeled and radioactive drugs logo, with instructions for use; the inner packaging must be labeled.
28, the transportation of radiopharmaceuticals or nuclides in empty containers, must be packaged in accordance with the relevant provisions of the State, dose detection and records.
29, packaging and transportation of radiopharmaceuticals should have a radiation dose with the appropriate protective devices.
30, radiopharmaceuticals must be carried out before leaving the factory radiation protection safety checks.
31, immediate labeling of radiopharmaceuticals should be equipped with special means of transportation.
32, the discovery of radiation on the patient overdose of harm, should be promptly reported to the local drug supervision and management department.
VII, Chinese medicine preparations
1, the person in charge of drug production and quality management must have specialized knowledge of Chinese medicine.
2, Chinese herbal medicines, Chinese medicine and tablets acceptance of personnel should be trained in related knowledge, with the identification of material true, good and bad skills.
3, non-traumatic external drug preparations and other special Chinese medicine preparations should be able to close the doors and windows of the production plant, if necessary, have good dehumidification, exhaust, dust, cooling and other facilities, personnel, materials and production operations should be referred to the management of clean (room) area.
For the direct entry of net herbs and dry paste ingredients, crushing, mixing, sieving and other plants should be able to be closed, with good
Ventilation, dust and other facilities, personnel, materials in and out of the production operation should be referred to the management of clean (room) area.
Other Chinese medicine preparation production environment of air cleanliness level requirements with sterile drugs, non-sterile drugs in the relevant requirements.
4, Chinese herbal medicine storehouse should be set up separately raw materials and net material warehouse, toxic herbs, precious herbs should be set up separately special library or special cabinet.
5, non-clean plant floors, walls, ceilings and other internal surfaces should be flat, easy to clean, not easy to peel, no mold, should not cause pollution of processing and production.
6, net selection of herbs should be set up in the plant picking workbench, workbench surface should be flat, not easy to produce shedding.
7, Chinese herbal concoctions in the steaming, frying, sizzling, calcining and other plants should be compatible with its production scale, and have good ventilation, dust, smoke, cooling and other facilities.
8, Chinese herbal medicines, Chinese medicine tablets, extraction, concentration and other plants should be appropriate to their production scale, and have good ventilation and prevention of pollution and cross-contamination facilities.
9, Chinese herbal medicine screening, cutting, crushing and other production operations should be installed in the plant to catch dust and other facilities.
10, and direct contact with the drug tools, containers should be clean surface, easy to clean and disinfect, not easy to produce shedding.
11, imported Chinese herbal medicines, Chinese medicine tablets should be port drug inspection report.
12, the purchase of Chinese herbal medicines, Chinese medicine should be recorded in detail, each package should be accompanied by a distinctive mark, indicating the name, specifications, quantity, origin, source, harvest (processing) date. Toxic herbs, flammable and explosive herbs should be clearly marked on the packaging.
13, Chinese herbal medicines must be used before picking, sorting, shearing, concocting, washing and other processing. Need to be infiltrated to achieve the drug through the water exhausted.
14, Chinese herbal medicines, Chinese medicine tablets should be stored to facilitate conservation.
15, the principle of batch division:
(1) solid preparations in the molding or dispensing before the use of the same mixing equipment to mix the amount of one time the production of homogeneous products for a batch. If the use of sub-mixing, verified, within the limits of the production of a certain amount of homogeneous products for a batch.
(2) liquid preparations, ointment, ointment, infusion cream, etc. to fill (seal) before the last mixing by the same mixing equipment, the last mixing of the liquid produced by a batch of homogeneous products.
16, the production of expensive and fine, toxic herbs, Chinese medicine and tablets, must be monitored in accordance with the provisions of the feeding, and have a record.
17. The following measures shall be taken to prevent cross-contamination and confusion during the production of Chinese medicinal preparations:
(1) Chinese herbal medicines shall not directly touch the ground.
(2) Drug production operations containing toxic herbs should have special measures to prevent cross-contamination.
(3) The washing of herbs after picking should use flowing water, and the used water should not be used for washing other herbs. Different herbs should not be washed together.
(4) The herbs and concoctions after washing and cutting shall not be dried in the open air.
18, the sterilization method of Chinese herbal medicines, intermediate products and finished products should be based on the principle of not changing the quality.
19, Chinese herbal medicines, Chinese medicine tablets cleaning, infiltration, extraction process water quality standards should be no less than drinking water standards. I hope it helps you