I. Inspection and Evaluation Methods
1, according to the "Good Manufacturing Practice (1998 Revision)" and its appendices, in order to unify the standards, standardize the certification inspection, to ensure the quality of the certification work, the development of drug GMP certification inspection and evaluation standards.
2, the drug GMP certification inspection program *** 225 items, of which 56 key items (article number before the "*"), 169 general items.
3, drug GMP certification inspection, shall apply for certification scope, in accordance with the drug GMP certification inspection program, to determine the scope and content of the corresponding inspection.
4, on-site inspection, should be listed in the project and its coverage of the content of a comprehensive inspection; should be made item by item, or negative assessment. Where incomplete, incomplete items, known as defective items; key items such as unqualified is known as serious defects; general items such as unqualified is known as general defects. General defective items or other problems found in the inspection seriously affect the quality of drugs is regarded as serious defects. Inspectors should be investigated to obtain evidence, detailed records.
5, the results of the assessment:
Projects
Serious defects general defects
0 ≤ 20% through the GMP certification
0 20-40%
≤ 3 ≤ 20%
≤ 3 ＞ 20%
>>>3
The second GMP certification inspection program
Drugs
Article Inspection content
* 0301 Whether the enterprise to establish the drug production and quality management organizations, and clarify the responsibilities of institutions and personnel at all levels.
0302 Whether the company is equipped with management personnel and technicians appropriate to the production of drugs, and have the appropriate professional knowledge.
0401 Whether the person in charge of production and quality management of the enterprise has a college degree or above in medicine or related majors, and has experience in drug production and quality management.
0402 Whether the person in charge of production and quality management of biological products production enterprises have appropriate professional knowledge (bacteriology, virology, biology, molecular biology, biochemistry, immunology, medicine, pharmacy, etc.), and have rich practical experience to ensure that in their production, quality management to fulfill their responsibilities.
0403 Whether the person in charge of drug production and quality management in the Chinese medicine preparation manufacturing enterprise has specialized knowledge of Chinese medicine.
0501 Whether the person in charge of the department of production management and quality management has a college degree or above in medicine or related majors, and has practical experience in drug production and quality management.
* 0502 Whether the department heads of production management and quality management are concurrent with each other.
0601 Whether the personnel engaged in pharmaceutical production and operation have received appropriate professional and technical training.
0602 Whether personnel engaged in the production of APIs to receive training in the production of APIs specific operation of the relevant knowledge.
0603 Chinese herbal medicines, Chinese herbal medicinal tablets acceptance of personnel whether the relevant knowledge of training, with the skills to identify the authenticity of herbs, superiority and inferiority.
0604 Whether personnel engaged in drug quality inspection by the appropriate professional and technical training.
0701 Whether personnel at all levels engaged in the production of drugs in accordance with the requirements of this specification for training and assessment.
0702 All personnel engaged in the manufacture of biological products (including cleaning personnel, maintenance personnel) whether according to the products they produce and the production operations engaged in professional (hygiene, microbiology, etc.) and safety protection training.
0801 enterprise drug production environment is clean, plant floors, pavement and transportation, etc., whether the drug production pollution, production, administration, living and auxiliary areas of the overall layout is reasonable; interfere with each other.
0901 plant according to the production process and its required air cleanliness level for a reasonable layout.
0902 production operations in the same plant and production operations between neighboring plants are mutually impeding.
1001 Whether the plant has facilities to prevent the entry of insects and other animals.
1101 clean room (area) of the inner surface is flat and smooth, no cracks, interface tight, no particles off, resistant to cleaning and disinfection.
1102 clean room (area) of the junction between the wall and the ground is curved or other measures.
1103 clean room (area) whether the use of non-shedding, easy to clean, easy to disinfect the hygiene tools, its storage location is not product contamination, and limit the use of the area.
1104 Chinese medicine production of non-clean plant floors, walls, canopies and other internal surfaces are smooth, easy to clean, not easy to shed, no mold stains, whether the processing and production of pollution.
1105 Whether the plant for net selection of herbs is equipped with picking workstations, and whether the surface of the workstations is smooth and not easy to produce shedding.
1201 Whether the production area has an area and space appropriate to the scale of production.
1202 Chinese herbal medicines, Chinese herbal medicinal tablets, extraction, concentration, steaming, frying, roasting, calcining and other plants are appropriate to their production scale.
1203 The quality inspection of intermediate products of raw materials and medicines and the production environment has a cross-influence, whether the inspection site is set in the production area.
1204 Whether the storage area has an area and space appropriate to the scale of production.
1205 Whether the storage area materials, intermediate products, products to be inspected are stored to prevent errors and cross-contamination measures.
1206 Raw materials of flammable, explosive, toxic, hazardous substances in the production and storage of plant facilities are in line with relevant state regulations.
1301 clean room (area) in a variety of pipelines, lamps, air intake and other utilities are easy to clean.
1401 clean room (area) of the illumination and production requirements are compatible, whether the plant has emergency lighting facilities.
*1501 into the clean room (area) of the air is purified according to regulations.
1502 clean room (area) of the air is in accordance with the provisions of the monitoring, air monitoring results are recorded and archived.
1503 clean room (area) of the purified air such as recycling whether to take effective measures to avoid contamination and cross-contamination.
1504 air purification system in accordance with the provisions of cleaning, repair, maintenance and record.
*1601 clean room (area) of the windows, canopy and into the indoor pipeline, air outlet, lamps and lanterns and walls or canopy connection parts are sealed.
1602 air cleanliness level is different between neighboring rooms whether there is an indication of the pressure difference between the device, static pressure difference is in line with the provisions.
1603 Whether the doors and windows of the production plant for non-traumatic external Chinese medicine preparations and their special preparations can be sealed, and if necessary, there are good facilities for dehumidification, exhaust, dust removal, cooling and other facilities.
1604 Whether the doors and windows of the plant for dosing, pulverizing, mixing, sieving, etc. of the net herbs and dry paste used for direct administration of medicine can be airtight, with good facilities for ventilation and dust removal.
1701 clean room (area) temperature and relative humidity is compatible with the requirements of the production process of drugs.
1801 clean room (area) of the pool, floor drain whether the drug pollution, 100 clean room (area) whether to set the floor drain.
1901 different air cleanliness levels of clean room (area) between the personnel and materials in and out, whether there are measures to prevent cross-contamination.
*1902 Whether transmission equipment used in Class 10,000 cleanrooms (zones) traverses lower-level areas.
*1903 clean room (area) and non-clean room (area) between the buffer facilities are set up, clean room (area)
people, logistics direction is reasonable.
*2001 production of penicillin and other highly allergenic drugs whether to use independent plants and facilities, independent air purification system, whether to maintain a relative negative pressure in the packaging room, packaging room exhaust to the outdoors is purified and comply with the requirements, packaging room exhaust is far from the air inlet of other air purification system.
*2002 The production of β-lactam structure of drugs and other types of drugs are strictly separated from the production area, the use of special equipment and independent air purification system.
*2101 sex hormones and other contraceptive drugs production plant is separate from the production of plant, whether or not equipped with independent special air purification system, gas emissions are purified.
*2102 Production of hormones, anti-tumor chemicals and other drugs whether to use the same equipment and air purification system; unavoidable, whether to use effective protective measures and the necessary verification.
*2201 Production of bacterial strains and non-production of bacterial strains, production cells and non-production of cells, strong and weak poison, dead and live poison, detoxification and detoxification of products and live and inactivated vaccines and live vaccines, human blood products, preventive products, such as processing or filling is carried out at the same time in the same production plant.
*2202 Production of bacterial strains and non-production of bacterial strains, production of cells and non-production of cells, strong and weak viruses, dead and live viruses, before and after the detoxification of products and live vaccines and inactivated vaccines, human blood products, prophylactic products, and other storage is strictly separated.
*2203 Whether the handling and filling of different types of live vaccines are separated from each other.
*2204 Whether the operation area of strong toxic microorganisms and adjacent areas to maintain a relative negative pressure, whether there is an independent air purification system, whether the discharged air is recycled.
*2205 Whether the operation area of bacteriophage products maintains relative negative pressure with adjacent areas, whether there is an independent air purification system, whether the discharged air is recycled, and whether the operation of bacteriophage products until the completion of the inactivation process is carried out with special equipment.
*2206 Various types of biological products involved in the production process of high-risk pathogenic factors in the operation, the air purification system and other facilities to meet the special requirements.
*2207 Whether the equipment for the production process of biological products using certain specific stages of living organisms is specialized, and whether it is carried out in an isolated or closed system.
*2208 Whether the BCG vaccine production plant and tuberculin production plant are strictly separated from the production plant of other products, and whether the BCG vaccine production equipment is dedicated.
*2209 Whether products of Bacillus anthracis, Clostridium botulinum and Clostridium tetani are produced in the corresponding dedicated facilities.
2210 Whether the equipment is dedicated to the production of spore-forming bodies, whether the production is centralized when processing one product, and whether only one product is produced within a specified period of time when the production of Bacillus products is staged and rotated within a facility or set of facilities.
*2211 Whether the plant and facilities for the production of biologics are potentially contaminated with raw materials, intermediates, and finished products.
*2212 Whether the production and calibration of polymerase chain reaction (PCR) reagents are performed in separate buildings to prevent cross-contamination from aerosols formed during amplification.
*2213 The production of human immunodeficiency virus (HIV) and other detection reagents, when using positive samples, whether there are protective measures and facilities in line with the appropriate provisions.
*2214 Production of seed batches and cell banks, whether or not in the provisions of the storage conditions of special storage, whether or not only allowed access to designated personnel.
*2215 Whether products produced from human blood, human plasma or animal organs and tissues as raw materials use special equipment, and whether they are strictly separated from the production of other biological products.
*2216 The production of biological products using closed-system biodigesters can be produced simultaneously in the same area (e.g., monoclonal antibodies and recombinant DNA products).
*2217 Various types of inactivated vaccines (including recombinant DNA products), toxoid and cell extracts, after they are inactivated or sterilized, may be used in the same filling room and filling and lyophilization facilities on an alternating basis with other sterile products. However, after a product is dispensed, it must be effectively cleaned and sterilized, and the effectiveness of cleaning and sterilization is periodically verified.
*2218 Operation of microorganisms with pathogenic effects is carried out in a specialized area, and whether the relative negative pressure is maintained.
*2219 Whether the bacterial (toxic) operation area and the sterile (toxic) operation area have their own independent air purification system, and whether the air from the pathogenic operation area is recycled.
*2220 Whether air from pathogens with a risk level of Category II or higher is discharged through sterilization filters, and whether the performance of the filters is regularly checked. When strongly contaminated materials of pathogens of category II or above are used for product production, are effective sterilization facilities available for their discharged dirt?
2221 Is the operation area and equipment for the production of biological products used for the processing of living organisms easy to clean and decontaminate, and can withstand fumigation and sterilization.
2301 Whether production operations such as pre-treatment, extraction, concentration of Chinese herbal medicines and washing or treatment of animal organs and tissues are strictly separated from the production of their preparations.
2302 Chinese herbal medicine steaming, frying, roasting, calcining and other plants are well ventilated, dust removal, smoke removal, temperature reduction and other facilities.
2303 Chinese herbal medicines, Chinese herbal medicinal tablets, extraction, concentration and other plants have good ventilation and prevention of pollution and cross-contamination and other facilities.
2304 Chinese herbal medicines screening, slicing, crushing and other operations have effective dust removal and exhaust facilities.
2401 non-sterile drugs produce a large amount of dust clean room (area) can not avoid cross contamination by dust capture, its air purification system is the use of return air. Non-sterile drugs air cleanliness level of the same area, dust production of large operating room whether to maintain a relatively negative pressure.
2501 and drugs in direct contact with the drying of air, compressed air and inert gases are purified to meet the production requirements.
2601 storage area is kept clean and dry, whether the installation of lighting and ventilation facilities. Whether the temperature and humidity control in the storage area meets the storage requirements, and is regularly monitored as specified. Sampling whether there are measures to prevent contamination and cross-contamination.
2701 clean room (area) in the weighing room or preparation room air cleanliness level is consistent with the production requirements, whether or not there are dust capture facilities, measures to prevent cross-contamination.
2801 laboratory, Chinese medicine specimen room, sample observation room is separate from the production area.
2802 Biological assay, microbial limit assay is carried out in separate rooms.
2901 Whether the instruments and meters with special requirements are placed in a special instrument room, with facilities to prevent static electricity, vibration, humidity or other external factors.
3001 Whether the experimental animal room is strictly separated from other areas, and whether the experimental animals comply with the relevant state regulations.
*3002 Animal rooms used for the production of biological products, quality control animal rooms are separated from the product production area.
*3003 Requirements for feeding and management of animals used in biological products, and whether they are in line with the provisions of the management of experimental animals.
3101 Whether the design, selection and installation of equipment meet the production requirements, are easy to clean, disinfect or sterilize, are convenient for production operation and maintenance, maintenance, and can prevent errors and reduce pollution.
3102 The capacity of the sterilization cabinet is compatible with the production batch, whether the sterilization cabinet has automatic monitoring and recording devices.
3103 Biological products production using piping systems, valves and ventilation filters are easy to clean and sterilization, closed containers (such as fermentation tanks) are sterilized with steam.
3201 Whether the surface of the equipment in direct contact with the drug is clean, smooth, easy to clean or disinfect, corrosion resistant, and does not chemically change with the drug or adsorb the drug.
3202 clean room (area) within the equipment insulation surface is flat, smooth, particulate matter off.
3203 and Chinese herbal medicines, Chinese medicine and tablets in direct contact with the tools, containers, the surface is clean, easy to clean and disinfect, not easy to produce shedding material.
3204 With the liquid contact equipment, containers, pipelines, valves, pumps, etc. Whether the use of high-quality corrosion-resistant materials, pipeline installation is to minimize the connecting (welding) joints.
3205 Whether the filter material adsorption of liquid components and the release of foreign objects, prohibit the use of filter material containing asbestos.
3206 Whether the lubricants, coolants, etc. used in the equipment are contaminated with drugs or containers.
3301 The main fixed pipeline connected to the equipment is labeled with the name of the material in the pipe, flow direction.
3401 Whether the preparation, storage, and distribution of purified water prevent microbial growth and contamination.
*3402 Whether the preparation, storage and distribution of water for injection prevents the growth and contamination of microorganisms, whether the vent of the storage tank is installed with a hydrophobic sterilizing filter that does not shed fibers, and whether the storage is insulated at 80°C or above, insulated and circulated at 65°C or above, or stored at 4°C or below.
*3403 Whether the materials used for storage tanks and conveying pipelines are non-toxic and corrosion-resistant, whether the design and installation of pipelines to avoid dead ends and blind pipes, whether the tanks and pipelines are required to provide cleaning and sterilization cycle.
*3404 Is the water for injection for the production of biological products used within 6 hours after preparation; 4 hours after preparation and sterilization within 72 hours.
3405 Whether the design, installation and maintenance of water treatment and its supporting systems ensure that the water supply meets the set quality standards.
3501 production and inspection instruments, meters, gauges, scales and other applicable range, precision is in line with the production and inspection requirements, whether there is a clear sign of conformity, whether regular calibration.
3601 Whether the production equipment has a clear status symbol.
3602 Production equipment is regularly repaired and maintained. Whether the operation of equipment installation, repair and maintenance affects the quality of the product.
3603 Non-sterile pharmaceutical drying equipment inlet air inlet filter, outlet air inlet to prevent air backflow device.
3604 Biological products in the production process of contaminated pathogens and equipment are separated from unused sterilized items and equipment, and there are obvious signs.
3701 production, inspection equipment, whether the use, repair and maintenance records, and managed by specialized personnel.
3801 material purchase, storage, issuance, use and so on whether to develop a management system.
3802 Raw materials, auxiliary materials are stored according to varieties, specifications, batch number.
*3901 Whether the materials comply with drug standards, packaging material standards, biological product protocols or other relevant standards, and shall not adversely affect the quality of drugs.
3902 Whether the raw materials and excipients are sampled and tested according to batch.
*3903 Imported raw materials, Chinese herbal medicines, traditional Chinese medicine tablets whether there is a port drug inspection report of the drug testing center.
4001 Whether Chinese herbal medicines are purchased according to quality standards, whether the origin remains relatively stable, and whether there are detailed records of purchased Chinese herbal medicines and traditional Chinese medicine tablets.
4002 Chinese herbal medicines, Chinese medicinal herbs, Chinese medicinal tablets, each package is accompanied by a distinctive mark, indicating the name, specifications, quantity, origin, source harvest (processing) date.
4101 Whether the material is purchased from the unit in accordance with the provisions of the regulations, and whether it is warehoused in accordance with the provisions of the regulations.
4201 pending inspection, qualified, unqualified materials are strictly managed.
*4202 Unqualified materials are stored in a special area, whether there is a clear sign that can be easily identified, and in accordance with the relevant provisions of the timely processing.
4301 Have special requirements of materials, intermediate products and finished products are stored in accordance with the specified conditions.
4302 Solid raw materials and liquid raw materials are stored separately, whether volatile materials to avoid contamination of other materials, concocted, sorted and processed net herbs whether to use clean containers or packaging, whether the net herbs and unprocessed, concocted herbs are strictly separated.
*4401 Narcotic drugs, psychotropic drugs, toxic drugs (herbs) are accepted, stored and kept according to regulations.
*4402 Bacteria and poisonous species are accepted, stored, kept, used and destroyed according to regulations.
4403 The use of raw materials of animal origin for biological products should be recorded in detail, including at least the source of the animal, the conditions of animal reproduction and breeding, and the health of the animal.
4404 Whether the animals used for vaccine production are clean grade or above.
4405 Whether or not a system of original seed lots, master generation seed lots and working seed lots of bacterial viruses for production is established.
4406 Whether the seed lot system has complete information on the original source of the bacteriophage, the identification of the characteristics of the bacteriophage, the genealogy of the transmission, whether the bacteriophage is a single pure microorganism, the characteristics of the production and cultivation, the optimal conditions of preservation, and so on.
4407 Whether the production of cells to establish the original cell bank, the main generation of cell bank and working cell bank system.
4408 Whether the cell banking system includes: the original source of cells (karyotyping, tumorigenicity), population ploidy number, transmission lineage, whether the cells are a single purified cell line, preparation method, optimal preservation conditions, and so on.
4409 Whether the flammable, explosive and other dangerous goods are accepted, stored and kept according to regulations.
*4410 Whether toxic herbs, precious and fine herbs are set up separately in special libraries or special cabinets.
4411 toxic herbs, flammable and explosive herbs on the outer packaging whether there is a clear sign of the provisions.
4501 Whether the materials are stored according to the specified period of use, whether the expiration of the period in accordance with the provisions of the re-inspection; storage period, if there are special circumstances in a timely re-inspection.
*4601 Drug labeling, instructions for use and drug supervision and management department approved the content, style, text consistent. Printed with the same contents of the label of the drug packaging, whether or not according to the label management.
*4602 Labeling, instructions for use whether the quality management department proofread error-free printing, distribution, use.
4701 Labeling, instructions for use are kept and received by a person.
4702 labeling, instructions for use according to the varieties, specifications, special cabinets (library) storage, whether the batch of packaging instructions issued, according to the actual need to receive.
4703 labeling whether the number of issued by the user check, sign. The number of labels used, the number of defective and the remaining number of the sum of the number and the number of applications in line.
4704 printed with the batch number of defective labels or surplus labels are destroyed by a person, whether or not there is a record of the number of issuance, use, destruction is recorded.
4801 Whether the enterprise has to prevent contamination of health measures and various health management system, and by a person in charge.
4901 Whether the production and air cleanliness level according to the requirements of the development of plant cleaning procedures, the contents of which include: cleaning methods, procedures, intervals, the use of detergents or disinfectants, cleaning methods and storage location of cleaning tools.
4902 Whether the production and air cleanliness level requirements for the development of equipment cleaning procedures, including: cleaning methods, procedures, intervals, the use of detergents or disinfectants, cleaning methods and storage location of cleaning tools.
4903 Whether the production and air cleanliness level requirements for the development of container cleaning procedures, including: cleaning methods, procedures, intervals, the use of detergents or disinfectants, cleaning methods and storage location of cleaning tools.
5001 Whether the production area to store non-production items and personal sundries, the production of waste is disposed of in a timely manner.
5002 At the end of production operations containing high-risk pathogens such as cholera, rat vaccine, immunodeficiency virus (HIV), hepatitis B virus, and other pathogens, are suspected contaminated items disinfected in situ and individually sterilized before being removed from the work area.
5101 locker rooms, bathrooms and toilets are set up whether the clean room (area) to produce adverse effects.
5201 The selection of work clothes is consistent with the production operation and air cleanliness level requirements, and shall not be mixed. Whether the texture of the clean work clothes is smooth, does not produce static electricity, does not shed fibers and particles.
5202 Whether the style of sterile work clothes and the way of wearing can cover all the hair, beard and feet, and can retain the human body shedding.
5203 Whether the work clothes used in different air cleanliness levels are cleaned and organized separately, disinfected or sterilized when necessary, and whether the work clothes have a cleaning cycle.
5204 100,000 or more areas of clean work clothes in the clean room (area) whether the washing, drying, finishing, whether or not according to the requirements of sterilization.
5301 clean room (area) is limited to the region's production operators and approved personnel to enter, the number of personnel is strictly controlled, the temporary outsiders are guided and supervised.
5302 into the clean area of the staff (including maintenance, auxiliary personnel) whether the regular health and basic knowledge of microbiology, clean operation and other aspects of training and assessment.
5303 During the production day of a biological product, production personnel shall not move from an area where live microorganisms or animals are handled to an area where other products or microorganisms are handled without clearly defined decontamination measures.
5304 Whether personnel unrelated to the production process enter vaccine-type production control areas, and whether they wear sterile protective clothing when entering.
5305 Whether personnel engaged in the operation of the production of biological products are separated from animal breeders.
5401 Whether personnel entering the clean room (area) make-up and wear jewelry, whether bare hands in direct contact with medicines, whether operators in the class 100 clean room (area) bare hands, unavoidable hand disinfection in a timely manner.
5501 clean room (area) is regularly disinfected; disinfectant is not contaminated equipment, materials and finished products, disinfectant varieties are regularly replaced to prevent the emergence of drug-resistant strains.
5601 Whether the drug production personnel have health records, whether the production personnel in direct contact with drugs at least once a year physical examination. Are patients with infectious diseases, skin diseases and people with wounds on the body surface engaged in the production of direct contact with drugs.
5602 Biological products production and maintenance, inspection and animal breeding operators, managers, whether the corresponding vaccine and regular physical examination.
5603 infectious diseases, skin diseases, people with wounds on the skin and potential adverse effects on the quality of biological products, whether or not to enter the production area for operation or quality inspection.
*5701 Does the enterprise carry out validation of drug production, and does it establish a validation team according to the validation object, put forward the validation project, formulate the validation plan, and organize the implementation.
*5702 Whether the validation of the drug production process includes the air purification system, process water system, production process and its changes, equipment cleaning, changes in the main raw and auxiliary materials.
*5703 Whether the validation of key equipment and aseptic drugs include sterilization equipment, liquid filtration and filling (dispensing) system.
5801 Whether revalidation is carried out after a certain cycle of production.
5901 After the completion of the validation work whether to write a validation report, by the person in charge of the validation work review and approval.
6001 Whether the data and analysis contents of the validation process are archived and saved in the form of documents, and whether the validation documents include the validation program, validation report, evaluation and recommendations, and approver.
6401 Whether to establish a management system for drafting, revising, reviewing, approving, withdrawing, printing and storage of documents.
6402 Whether the documents distributed and used are the approved current version. Whether withdrawn and obsolete documents are present at the work site, in addition to being kept on file for inspection.
6501 Whether documents are prepared in accordance with regulations.
*6601 Whether there are production process regulations, job operating law or standard operating procedures, whether they are changed arbitrarily, and whether they are implemented in accordance with the prescribed procedures when changes are required.
6602 Are biological products produced in strict accordance with the "China Biological Products Regulations" or the process methods approved by the State Drug Administration.
6701 Whether the product is checked for material balance. If the material balance exceeds the specified limit, the reason should be identified, and the product can be treated as a normal product only after a reasonable explanation has been arrived at and it has been confirmed that there is no potential quality incident.
6702 Whether the precious and fine, toxic herbs and traditional Chinese medicine tablets required in the production of traditional Chinese medicine preparations are monitored and fed according to the regulations and recorded.
6801 Whether to establish batch production records. Batch production records are filled out in a timely manner, clear handwriting, true content, complete data, and signed by the operator and reviewer.
6802 Whether the batch production records are kept neat, not torn and arbitrarily altered. Batch production records are filled out in error, whether or not to change according to regulations. Batch production records are filed according to the batch number, kept until one year after the expiration date of the drug; no validity period of the drug, the batch production records are kept for three years.
6803 Whether the production records of APIs are traceable, and their batch production records start at least from the refining process of crude products.
*6901 Whether the drugs are divided into production batches according to the regulations, and prepare the production batch number.
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