1, what does GMP mean
A: GMP stands for Good Manufacturing Practice. It is a set of systematic and scientific management norms to ensure the production of high-quality drugs with scientific, reasonable and standardized conditions and methods in the whole process of drug production, and it is the basic criterion of drug production and quality management.
2. What is the central content of 2.GMP?
A: The central content of GMP is drug quality first. In order to achieve this goal, it is necessary to achieve:
(1) Clean the workshop and environment; (2) Strict quality management;
(3) Modernization of pharmaceutical equipment; (4) programmed production operation;
(5) various management standardization; (6) Institutionalization of personnel training;
(7) scientific verification; (8) Regularization of health work.
3. What are GSP, GLP, GCP and GAP?
A: GSP is the English abbreviation of "Good Quality Management Standard for Pharmaceutical Trading";
GLP is the quality management standard of drug non-clinical research;
GCP is the management standard of drug clinical trials;
GAP is the quality management standard of Chinese herbal medicine.
4. What are OTC drugs?
A: OTC drugs are over-the-counter drugs. They can be judged, purchased and used by themselves without a doctor's prescription.
5. What is the difference between 5.GMP and TQC?
A: GMP is the embodiment of total quality management (TQC) in pharmaceutical production. TQC is all about data, the word "complete" is the most important, GMP is all about evidence, and the word "strict" is the most important. Therefore, it can be said that TQC is the guiding ideology of GMP and GMP is the implementation scheme of TQC.
6. What's the difference between 6.QA and QC?
A: QA is the abbreviation of quality assurance. Its main work is the formulation, review and supervision of documents and the review and distribution of finished products.
QC is the abbreviation of quality control, which controls quality through microbial and physical and chemical identification.
7. What is the main content of 7.GMP?
Answer: It can be summarized as wet end, hardware and software. Wet department refers to personnel, hardware refers to factories, facilities and equipment, and software refers to management regulations such as organization, system, technology, operation, hygiene standards, records and education.
8. What are the particularities of drugs?
A: Drugs have the following characteristics: complexity of varieties, particularity of medical treatment, strictness of quality, standardization of production, dual use, scientificity of examination and approval, professionalism of inspection, timeliness of use and priceless benefits.
9. good manufacturing practice (1998 edition) * * * chapters, when will it be implemented?
A: * * * * There are 88 articles in 14, which will come into force on 1 August, 9991day.
10. How many chapters and articles does the Drug Administration Law include? When will it be implemented?
A: The current Drug Administration Law was revised at the 20th meeting of the Ninth National People's Congress on February 28th, 2000 106, which came into effect on February 28th, 2000106.
1 1. What are the requirements for starting a pharmaceutical manufacturing enterprise?
A: To start a pharmaceutical production enterprise, the following conditions must be met:
(1) having qualified pharmaceutical technicians, engineering technicians and corresponding skilled workers;
(2) Having factories, facilities and sanitary environment suitable for its pharmaceutical production;
(3) Having institutions, personnel and necessary instruments and equipment capable of managing and inspecting the quality of the drugs produced;
(4) Having rules and regulations to ensure the quality of drugs.
12, what is the national drug standard?
The Pharmacopoeia of People's Republic of China (PRC) issued by the State Council Drug Administration and the drug standards of the Ministry of Health are national drug standards. Drugs must meet the national standards.
13. Why is GMP a good teaching material for employee training?
A: GMP implementation must be combined with the actual situation of enterprises, including organizational structure, personnel composition and quality, products and other factors. For ordinary employees, it is more important to train basic GMP knowledge so that they can follow rules in their daily work. Through the study of GMP documents, you can not only master basic work skills in an all-round way, but also be familiar with all aspects of GMP requirements.
14. Why do GMP documents need to specify approval date and execution date?
A: GMP documents cannot be implemented on the day of approval, and it is necessary to go through the formalities of issuing documents. This process takes some time, and the newly approved documents also need training. So there is a gap between the approval date and the execution date.
15. What should I pay attention to when issuing GMP documents and recycling expired documents?
Answer: The documents issued must be recorded and signed by the recipient; Take back the invalid documents together on the day when the new documents are executed, and make records; The obsolete documents shall be destroyed by the document management department.
What are the three major objectives of 16 and GMP?
Answer: ① Keep human error to a minimum; (2) prevent drug pollution; ③ Establish a strict quality assurance system to ensure product quality.
17 what is SMP? What does it contain?
A: SMP is the abbreviation of standard management program. It includes: (1) document management, (2) material management, (3) production management, (4) quality management, (6) equipment and measurement management, (6) verification management, (8) administration management, (9) health management, (9) personnel training management, (/kloc-0)
18, what is SOP? What does it contain?
SOP is the abbreviation of standard operating procedure. It includes: (1) production operation procedures; (2) Quality control procedures; (3) Equipment metering operation procedures; (4) Material handling procedures; 5] cleaning procedures; [6] Health operation procedures;
19. How to conduct GMP self-inspection?
A: In order to ensure the effectiveness of the enterprise quality assurance system and to control the whole process of drug production consistently, in the process of GMP implementation, special personnel are organized to conduct a comprehensive self-inspection on the GMP implementation of the enterprise every other cycle, or list the main quality problems of the enterprise, make rectification, and then conduct spot checks or tracking, and record the results. In the self-inspection of the next cycle, first check whether the problems found last time have been rectified and what problems exist in the rectification, and at the same time list the problems found this time as the rectification content again. The results of each self-inspection and the rectification plan shall be recorded in detail.
20. How are the current GMP documents classified?
A: The current GMP documents are divided into two categories, namely, standard documents and record voucher report documents. Under the standard category, it is divided into: technical standard documents, management standard documents and work standard documents.
21.What are the principles of GMP training?
A: (1) All participants. Management personnel at all levels, production, inspection, maintenance, cleaning, storage and transportation, and marketing service personnel of pharmaceutical enterprises shall receive education and training according to the requirements of specifications and their respective responsibilities.
(2) Develop training contents according to the requirements of different training objects.
(3) Institutionalization and standardization of training and education. Establish training files for trainers, conduct regular assessment, and archive the assessment results.
22. What are the requirements of GMP for the environment and region of pharmaceutical production enterprises?
A: Pharmaceutical manufacturing enterprises must have a clean production environment and a certain green area; The ground of the factory area should be completely hardened, and the road surface and transportation should not cause pollution to drug production; The overall layout of production, administration, living and auxiliary areas should be reasonable, separate from each other and not interfere with each other.
23. What requirements should the inner surface of clean area meet?
Answer: the inner surface of the clean area should be smooth, without cracks, tight joints and no particles falling off, which can withstand cleaning and disinfection. The junction between the wall and the ground should be isolated or other measures should be taken to reduce dust accumulation and facilitate cleaning.
24. What is the illuminance in the clean area?
Answer: The illumination of the main studio should be no less than 300 lux; Local lighting can be set in the production parts with special requirements for lighting.
25, drug production clean room (area) air cleanliness is divided into several levels?
Answer: The air cleanliness of clean rooms (areas) for pharmaceutical production is divided into four levels, namely 100, 10000, 10000 and 300000.
Attachment: air cleanliness grade of clean room (area)?
Maximum number of dust particles allowed under cleanliness level (pieces /m3) Maximum number of microorganisms allowed.
≥0.5μm≥5μm planktonic bacteria settling bacteria
(piece/cubic meter) (piece/plate)
100 level 350005 1
10000 Level 3500002000 1003
100000 Level 3,50000020,00050010
300,000 grade10,500,00060,00010,00015
The air entering the clean room (area) must be purified, and the air cleanliness level shall be classified according to the production process requirements. The number of microorganisms and dust particles in the air in the clean room (area) should be monitored regularly, and the monitoring results should be recorded and archived.
26. Briefly answer the procedures and requirements for changing clothes and shoes in the clean area?
One shift: enter the shoe cabinet of one shift, open the shoe cabinet of the inner shift sideways, take out the work shoes and general production areas, open the shoe cabinet of the outer shift, take off the shoes, put it in the shoe cabinet of the shift, put on the work shoes, and lock the cupboard door conveniently. Enter the dressing room in the general production area, open the locker, take off your coat and put it in the locker. At the same time, put the articles irrelevant to production into the locker, put on the working cap and overalls in turn, and close the cupboard door to enter the buffer room. Hand washing and disinfection.
The second shift: enter the second shift shoe cabinet, open the inner shift shoe cabinet sideways, take out the clean area work shoes, open the outer shift shoe cabinet, take off the general production area work shoes, put it in the shift shoe cabinet and put on the work shoes. Enter the dressing room in the clean area, open the locker, take off the work clothes in the general area, put them in the locker, put on the working cap, mask, coat, undress in turn, and close the cupboard door to enter the buffer room. Wash your hands, dry them and disinfect them.
Dress code: (1) Work clothes should be neatly dressed, and the work hat should cover all the hair and not be exposed. ⑵ Close the lockers, lockers and doors. (3) clean clothes and coats should be plunged into clothes.
27. What is the pressure difference between clean room and non-clean room and adjacent rooms with different cleanliness levels?
Answer: The static pressure difference between adjacent rooms with different air cleanliness levels should be greater than 5 Pa, and the static pressure difference between clean room (area) and outdoor atmosphere should be greater than 10 Pa, and there should be a device to indicate the pressure difference (differential pressure gauge).
28. How to purify the air entering the clean area?
Answer: The air entering the clean area is filtered by three-stage air filters with primary effect (also called coarse effect), medium effect and high efficiency, so that the air can reach the required clean level. Because the high-efficiency filter can filter out dust particles < 1 micron (micron) and the penetration rate to bacteria is 10-6, the air passing through the high-efficiency filter can be regarded as sterile.
29. What is the temperature and relative humidity of the clean room?
Answer: The temperature and relative humidity of clean room (area) should meet the requirements of pharmaceutical production process. Unless otherwise specified, the temperature should be controlled at 18 ~ 26℃ and the relative humidity should be controlled at 45 ~ 65%.
30, clean room (area) management need to meet what requirements?
Answer: The management of clean room (area) shall meet the following requirements:
(1) The personnel entering the clean room (area) must change shoes, clothes, wash hands and disinfect as required before entering the clean room (area). The number of clean rooms (areas) should be strictly controlled. Its staff (including maintenance and auxiliary personnel) should regularly carry out training and assessment of basic knowledge of hygiene, microbiology and cleaning operation; Guidance and supervision should be given to temporary outsiders who have been approved to enter the clean room (area), and they should be registered for future reference.
(2) Buffer facilities must be set between clean room (area) and non-clean room (area) to make people and logistics flow reasonably.
(3) The clean work clothes in the area above 300,000 level should be washed, dried and sorted in the clean room (area), and disinfected as required when necessary.
(4) The surface of the equipment insulation layer in the clean room (area) should be smooth and bright, and no particles will fall off.
(5) Clean rooms (areas) should use clean sanitary tools that are easy to clean and disinfect, and the sanitary tools should be stored in special sanitary ware rooms.
(6) The number of dust particles and settling bacteria detected in the clean room (area) under static conditions must meet the requirements, and the cleanliness under dynamic conditions should be monitored regularly.
(7) The purified air in the clean room (area) can be recycled, and fresh air can be supplemented appropriately. For the process with large dust production, the return air should be discharged to the outside to avoid pollution and cross-pollution;
(8) The air purification system shall be cleaned, repaired and maintained according to regulations and recorded, and indoor disinfection and floor drain cleaning shall be recorded.
(9) Production tools, containers, equipment, finished products and intermediate products shall be stored in a fixed place and marked with status.
3 1. How does the material enter the clean area?
Answer: (1) Before the materials enter the clean area (room), the outer packaging should be removed in the temporary storage room, and the inner packaging of the materials should be cleaned and disinfected if necessary.
(2) Convey it to the clean area (room) through the buffer room or transfer window, and pay attention to close the door of the buffer room or transfer window in time to prevent pollution caused by external air backflow.
32. What are the disinfection methods for clean areas (rooms)?
Answer: In the pharmaceutical process, the conventional methods of disinfection and sterilization in clean areas (rooms) include ultraviolet lamp irradiation, lactic acid, formaldehyde, ethylene oxide fumigation and spraying. However, the traditional sterilization method has many shortcomings, such as weak penetration of ultraviolet lamp irradiation and dead angle; Chemical fumigation will have pollution problems more or less, which is harmful to operators. Our company mainly adopts the method of ozone sterilization, which does not contain any toxic residues, thus solving the problem of secondary pollution and eliminating the need for cleaning again after disinfection.
33. What are the procedures for foreigners to enter the clean area?
Answer: Foreign personnel (including visitors, inspectors and maintenance personnel of equipment manufacturers) must be approved by the production department or the quality assurance department and accompanied by a special person. You must register before entering the clean room (area), then change your shoes and clothes according to the hygiene regulations, and you can enter after disinfection.
34. How to disinfect the stationery materials used in the clean area?
A: The stationery materials used in the clean area need to be disinfected by ultraviolet radiation for 30 minutes. Records can only be filled in with ballpoint pens, and pencils, pens, brushes and chalk are not allowed.
35. Are the varieties protected by traditional Chinese medicine the same as those protected by new drugs?
A: They are different, but the effect is the same. New drug protection refers to the protection period given by the state when a new drug is approved for marketing. The purpose is to encourage the creation of new drugs, protect the enthusiasm of scientific research and production units in research, development and production of new drugs, and avoid repeated research and production. Variety protection of traditional Chinese medicine means that the drug supervision and administration department of the State Council implements classified protection for varieties of traditional Chinese medicine with stable quality and definite curative effect in order to improve the quality of drugs, protect the legitimate rights and interests of Chinese medicine manufacturers and promote the development of traditional Chinese medicine.
36. What are the requirements for the environment when sampling auxiliary materials and packaging materials?
Answer: A sampling room can be set up in the storage area, and the air cleanliness level of the sampling environment should meet the production requirements. If sampling is not carried out in the sampling room, measures should be taken to prevent pollution and cross-contamination during sampling (for example, a sampling vehicle with purification function can be used).
37. What are the requirements for materials during storage?
Answer: Materials, intermediate products and finished products with special requirements for temperature, humidity or other conditions should be stored according to the specified conditions. Drugs that need to be stored in a cool warehouse shall be stored in a special cool warehouse. Solid and liquid raw materials should be stored separately; Volatile materials should pay attention to avoid polluting other raw materials; The processed medicinal materials should be in clean containers or packages, and strictly separated from unprocessed and processed medicinal materials. Materials should be stored according to the specified service life. If the service life is not specified, the storage period is generally not more than three years, and the reinspection will be carried out after the expiration. The system of periodic reinspection during material storage shall be specified. In case of special circumstances, recheck in time. Flammable and explosive dangerous goods are stored in a special dangerous goods warehouse with fire safety facilities.
38. What are the requirements for keeping and collecting drug labels and instructions for use?
Labels and instructions for use of drugs shall be kept and collected by special personnel, and the requirements are as follows:
(1) Labels and instructions for use are put into special counters or special stocks according to varieties and specifications, distributed according to batch packaging instructions, and collected according to actual needs.
(2) The labels shall be counted, issued, checked and signed by the recipients, and the sum of the used, damaged and remaining quantities shall be consistent with the number of recipients. The remaining labels or damaged labels with batch numbers shall be counted and destroyed, and the quality management department shall supervise the destruction.
(3) The issuance, use and destruction of labels shall be recorded, and a special person shall be in charge.
39, drug labels, instructions must indicate what content? What are the rules for printing, distribution and use?
A: Drug packaging must be printed or affixed with instructions in accordance with regulations.
Labels or instructions must indicate the generic name, ingredients, specifications, manufacturer, approval number, product batch number, production date, expiration date, indications or functional indications, usage, dosage, contraindications, adverse reactions and precautions.
The labels of narcotic drugs, psychotropic drugs, toxic drugs for medical use, radioactive drugs, drugs for external use and over-the-counter drugs must be marked with prescribed marks.
The labels and instructions for use of drugs must be consistent with the contents, styles and words approved by the drug supervision and administration department. Labels and instructions for use must be printed, distributed and used after being audited by the quality management department of the enterprise.
40. How many status signs of material management are there in the warehouse?
Answer: Material management is divided into: a, pending inspection, marked in yellow; B, qualified, with a green sign; C, unqualified, with a red sign; D, return, with blue sign.
4 1, how to deal with unqualified packaging materials?
Answer: Unqualified printing and packaging materials must be destroyed under the supervision of the quality management department, otherwise it will cause serious consequences once lost.
42. Why is supplier management one of the important contents of GMP?
A: As the starting material of drug production, the quality of raw and auxiliary materials will directly affect the final quality of drugs. Due to the mistakes or confusion of raw and auxiliary materials in the production process of suppliers, there are many incidents that lead to unqualified drugs. Therefore, we should strengthen the management of suppliers, control the quality from the source, then control and manage the acceptance and use process, and finally ensure the quality of the drugs produced.
43. What five preventive facilities should the warehouse take?
Answer: Five precautions refer to fire prevention, theft prevention, rat prevention, mildew prevention and insect prevention.
44. What is drug packaging?
Answer: the inner packaging of drugs refers to the packaging that is in direct contact with drugs (such as aluminum foil, PVC, composite film for pill packaging, waxed paper, etc.). For ampoules, oral liquid bottles, tablets or capsules).
45, drug packaging materials are divided into several categories?
Answer: classification of packaging materials: packaging materials are divided into three categories: I, II and III.
The first category of packaging materials refers to the materials and containers for drug packaging that are in direct contact with drugs and used directly.
Class II packaging materials refer to packaging materials, materials and containers that are in direct contact with drugs, but easy to clean, and need to be disinfected and sterilized after cleaning in actual use.
The third category of packaging materials refers to other pharmaceutical packaging materials and containers that may directly affect the quality of drugs except the first and second categories of packaging materials.
46. What should I pay attention to when stacking materials?
Answer: (1) Stack spacing is not less than100 cm; ;
(2) The distance between the crib and the wall is not less than 50 cm; ;
(3) The spacing between the stack and the beam is not less than 30cm；;
(4) The spacing between piles shall not be less than 30cm；;
(5) The distance between the crib and the ground shall not be less than10cm; ;
(6) The distance between the heating pipe of the water heating radiator and the cargo stack shall be not less than 30cm；;
(7) The distance between the vertically lower lighting fixtures and the stored materials should be greater than 50 cm.
47. How to manage the cool warehouse?
Answer: The temperature of the cold storage should be kept below 20℃, and the warehouse should have special cooling and dehumidification facilities. Finished products, intermediates, raw and auxiliary materials, etc. If it is explicitly required to be stored in a cool and dry place, it should be stored in a cool warehouse.
48, dangerous goods warehouse management should pay attention to?
Answer: (1) The dangerous goods warehouse should be built in an area far away from production and at a certain distance from other buildings that meet the fire protection requirements.
(2) Dangerous goods warehouse should be clearly marked and equipped with fire fighting equipment such as shovels, sand pools, buckets and nylon hoses.
(3) Smoking and fire are prohibited in the dangerous goods warehouse, and shoes with nails are prohibited to prevent sparks.
(4) Inflammable and explosive reagents for laboratory inspection shall be stored in a special iron cabinet in the dangerous goods warehouse, and an account card shall be established according to the provisions on material storage.
49. What are the main contents of technological procedures, post operation methods and standard operating procedures (SOP)?
A: The contents of production process regulations include: product name, dosage form, prescription, operation requirements of production process, quality standards and technical parameters of materials, intermediate products and finished products, storage precautions, calculation method of material balance, requirements of finished product containers and packaging materials, etc.
The contents of post operation method include: production operation methods and requirements, review of key operations, quality standards and control of intermediate products, safety and labor protection, equipment maintenance and cleaning, handling and reporting of abnormal situations, process hygiene and environmental hygiene.
The contents of standard operating procedures include: title, number, creator and date, approver and date, approver and date of approval, issuing department, production date, issuing department, title and text.
50. What is the content of the batch production record?
A: The contents of batch production records include: product name, production order, production batch number, production date, signatures of operators and auditors, related operations and equipment, product quantity in related production stages, material balance calculation, production process monitoring records, intermediate product turnover, liquidation, process verification and special problem records, and finished product release audit.
5 1. What are the requirements for filling in batch production records? How long will it last?
Answer: Batch production records should be legible, true in content and complete in data, and signed by operators and auditors. Records shall be kept clean and tidy, and shall not be torn up or altered at will; When making changes, sign the changes and make the original data still recognizable.
Batch production records should be filed according to batch number and kept for one year after the drug is valid.
52. How to prevent drugs from being polluted and confused in the process of production and operation?
Answer: In order to prevent drugs from being contaminated and confused, the following measures should be taken in production operation:
(1) Before production, make sure that there are no leftovers in the last production;
(2) The generation and diffusion of dust should be prevented;
(3) Production operations of different product varieties and specifications shall not be carried out simultaneously in the same production operation room. When several packaging lines are packaged at the same time, isolation or other effective facilities to prevent pollution and confusion should be adopted;
(4) In the production process, cross-contamination caused by gas, steam, spray or organic matter generated by materials and products should be prevented.
(5) Each production workshop or production equipment and container shall be marked with the name, batch number and quantity of the products or materials produced;
(6) The selected medicinal materials should be washed with running water, and the used water should not be used to wash other medicinal materials. Medicinal materials with different medicinal properties shall not be washed together. Washed medicinal materials and processed products are not allowed to be dried in the open air, and must be dried in a clean kang room, oven or drying equipment.
The sterilization method of primary drugs and their intermediate products should be based on the principle of not changing the efficacy and quality of medicinal materials, and the powder of medicinal materials directly used as medicine should be examined for microorganisms before batching.
53. What is the content of the batch packaging record?
Answer: The contents of batch packaging records include:
(1) Name, batch number and specifications of this batch of packaged products;
(2) Label with batch number, instructions for use and product certificate;
(3) The number of products and packaging materials to be packaged and the signatures of the issuer, receiver and auditor;
(4) the number of packaged products;
(5) The settlement record of the last packaging operation (copy) and the settlement record of this packaging (original);
(6) The inspection and verification results after the completion of this packaging operation and the signature of the reviewer;
(7) Signature of the person in charge of production operation.
54. How to fill in the customs clearance record? What is the content of the customs clearance record?
A: After the first production stage of each batch of drugs is completed, the production operators must clear the field and fill in the clearing record. The contents of the release record include: working procedure, product name, production batch number, release date, inspection items and results, and signatures of the person in charge of release and the auditor. The release record shall be included in the batch production record, and attached with the release certificate. The release record of packaging process is divided into original and copy, the original is in this production record and the copy is in the batch record of the next shift. Other processes only need a liquidation record.
55. What is the principle of batch division?
Answer: (1) Before molding or subpackaging, solid preparations are mixed once with the same mixing equipment to produce a batch of homogeneous products. If batch mixing is adopted, it is proved that a certain number of homogeneous products are produced as a batch within the specified limit;
(2) Liquid preparation: Before the liquid preparation is filled (sealed), a batch of homogeneous products are produced from the liquid medicine mixed for the last time by the same mixing equipment.
56. What are the processing methods of Chinese herbal medicines?
A: The processing methods of Chinese herbal medicines can be divided into: washing, elutriation, cutting, frying, steaming, vinegar roasting, frying ginger, calcining and so on. According to the technological requirements, the processing is based on China Pharmacopoeia and Henan Chinese Herbal Medicine Processing Standard.
57. What is the purpose of processing traditional Chinese medicine?
A: The purpose of processing traditional Chinese medicine is to reduce or eliminate the side effects of drugs and change or alleviate their medicinal properties. Improve the curative effect; Change or increase the site and trend of drug action; Easy to adjust and prepare; Ensure the cleanliness of drugs and facilitate storage; Conducive to taking.
58. What documents were reviewed and filed as attachments to batch production records?
Answer: In addition to batch production records, it should also include: material weighing records (material batch number and quantity), intermediate products and finished products warehousing records, automatic printing records (automatic weighing and automatic temperature control), settlement records, intermediate products and finished products inspection reports.
59. Does the batch production record include the inspection records of raw and auxiliary materials and packaging materials?
Answer: In batch production records, raw materials and packaging materials are required to record their original inspection report numbers. According to the inspection report number, the incoming inspection of materials can be tracked. Therefore, it is not necessary to include the original inspection records in the batch records. Raw materials used in production should have batch number records, from which the source can be traced back.
60. What are the requirements for pharmaceutical process water?
Answer: (1) Drinking water should meet the drinking water standard of the Ministry of Health 5. (Inspection by epidemic prevention department is required)
(2) Purified water should meet the standards of China Pharmacopoeia.
(3) Water for injection should meet the standards of China Pharmacopoeia.
6 1. What are the routine inspection items of process water?
Answer: (1) The conductivity of drinking water is checked every day.
(2) Check the PH value, chloride, ammonia salt and conductivity of purified water daily.
62. What should I pay attention to when storing pure water?
Answer: The preparation, storage and distribution of purified water should take measures to prevent microbial growth and pollution, and should be stored in stainless steel storage tanks at room temperature. Pure water is not used for more than 24 hours. Empty it once.
63. How to deal with the deviation in the production process?
Answer: In the production process, the discoverer should fill in a notice of deviation, indicating the product name, batch number, specification, quantity, working procedure, deviation content, occurrence process and reason, location, date, and the signature of the filler, due to the deviation change of process conditions, sudden abnormality of equipment, deviation of product quality, material leakage, the number of labels used does not match the number of materials used, or the material balance is beyond the acceptable range of yield. Report the deviation notice to the workshop, production and quality management department, which will organize the investigation. According to the investigation results, the control measures are put forward. Treatment principle: if it is confirmed that the final quality of the product will not be affected, it can continue to process, recycle and reuse, or rework after taking remedial measures, and it is confirmed that the product quality may be affected; Scrap or destroy.