In terms of human medicine, it was issued by the Ministry of Health in mainland China in 1988, known as the Good Manufacturing Practice (GMP), and has been revised several times since then, with the latest being the 2010 revision. China's veterinary drug industry GMP was implemented in the late 1980s. 1989 China's Ministry of Agriculture issued the "Veterinary Drug Production Quality Management Standard (Trial)", and in 1994 issued the "Veterinary Drug Production Quality Management Standard Implementation Rules (Trial)". 1995 October 1, where the conditions of the pharmaceutical production enterprises (workshops) and drug varieties, can be in accordance with the application of pharmaceutical GMP certification . GMP certification of pharmaceutical enterprises (workshops), in the application for the production of new drugs, health administrative departments to be given priority. As of June 30, 1998, did not obtain drug GMP certification of enterprises (workshops), health administrative departments will no longer accept applications for the production of new drugs. March 19, 2002, the Ministry of Agriculture revised the release of the new "Veterinary Drug Production Quality Management Standards" (referred to as "Veterinary Drug GMP specifications"). Announcement No. 202 was issued on June 14 of the same year, stipulating that from June 19, 2002 to December 31, 2005 is the transitional period for the implementation of the GMP Specification for Veterinary Drugs, and that it will be mandatorily implemented from January 1, 2006 onwards. At present, China's drug supervision and management authorities vigorously strengthen the supervision and management of drug production, and the implementation of GMP certification has achieved milestones. Now blood products, powder injection, large volume injection, small volume injection manufacturers are all in accordance with GMP standards. The state hopes to improve the overall level of drug production management through GMP certification to avoid low-level duplication of construction. Enterprises that have passed the GMP certification can inquire at the Drug Certification Management Center.
The Good Manufacturing Practice (2010 Revision) has been considered and approved by the Ministry of Health on October 19, 2010, and is hereby promulgated and shall come into force on March 1, 2011, as of the same date.
Specification for the Quality Management of Pharmaceutical Manufacturing (Revised 2010)
Chapter 1 General Provisions
Article 1 In order to standardize the quality management of pharmaceutical manufacturing, this specification is formulated in accordance with the "Chinese People's Republic of China*** and the State Law on Drug Administration" and the "Regulations for Implementation of the Chinese People's Republic of China*** and the State Law on Drug Administration". Article 2 The enterprise shall establish a drug quality management system. The system should cover all factors affecting the quality of medicines, including ensuring that the quality of medicines in line with the intended use of all organized and planned activities. Article III of this specification as part of the quality management system, is the basic requirements of drug production management and quality control, aimed at minimizing the process of drug production contamination, cross-contamination, and confusion, errors and other risks, to ensure the sustained and stable production of pharmaceutical products in line with the intended use and registration requirements. Article 4 Enterprises shall strictly implement this specification, adhere to honesty and trustworthiness, and prohibit any false and deceptive behavior.
Chapter II Quality Management
Section I Principles Article 5 Enterprises shall establish quality objectives in line with the requirements of drug quality management, and systematically implement all the requirements of drug registration regarding safety, efficacy and controllable quality into the whole process of drug production, control and product release, storage and shipment to ensure that the drugs produced comply with the intended use and the requirements of registration. Article 6 The senior management of the enterprise shall ensure the realization of the established quality objectives, different levels of personnel, as well as suppliers, distributors should *** with the participation and assume their respective responsibilities. Article 7 The enterprise shall be equipped with sufficient and meet the requirements of personnel, plant, facilities and equipment to provide the necessary conditions for the realization of quality objectives. Section II Quality Assurance Article 8 Quality assurance is part of the quality management system. Enterprises must establish a quality assurance system, as well as the establishment of a complete documentation system to ensure the effective operation of the system. Article 9 The quality assurance system shall ensure that: Article 10 The basic requirements for quality management of pharmaceutical production: Section III Quality Control Article 11 Quality control includes the corresponding organizational structure, documentation system, as well as sampling, inspection, etc., to ensure that the materials or products complete the necessary inspections prior to release to confirm that their quality meets the requirements. Article 12 The basic requirements of quality control: Section IV Quality Risk Management Article 13 Quality Risk Management is a systematic process of quality risk assessment, control, communication, and auditing throughout the product life cycle using a forward-looking or retrospective approach. Article 14 Quality risks shall be assessed based on scientific knowledge and experience to ensure product quality. Article XV of the quality risk management process used in the methods, measures, forms and documents should be appropriate to the level of risk.
Chapter III Institutions and Personnel
Section I. Principles Article 16 The enterprise shall establish a management body appropriate to the production of drugs, and have an organizational chart. Enterprises shall establish an independent quality management department to fulfill the responsibilities of quality assurance and quality control. The quality management department may establish a quality assurance department and a quality control department separately. Article 17 The quality management department shall participate in all quality-related activities and be responsible for reviewing all documents related to this specification. The personnel of the quality management department shall not delegate their duties to the personnel of other departments. Article 18 The enterprise shall be equipped with a sufficient number of management and operation personnel with appropriate qualifications (including education, training and practical experience), and the duties of each department and each position shall be clearly defined. Job duties shall not be omitted and cross-cutting duties shall be clearly defined. There should not be an excessive number of duties assigned to each individual. All personnel shall clearly identify and understand their duties, familiarize themselves with the requirements related to their duties, and receive the necessary training, including pre-service and continuing training. Article 19 Duties shall not normally be delegated. If it is necessary to delegate, the duties may be delegated to a designated person with equivalent qualifications. Section II Key Personnel Article 20 The key personnel shall be full-time personnel of the enterprise, including at least the person in charge of the enterprise, the person in charge of production management, the person in charge of quality management and the quality authorized person. The person in charge of quality management and the person in charge of production management shall not act concurrently with each other. The person in charge of quality management and the authorized person for quality may be appointed concurrently. Operating procedures should be developed to ensure that the quality of authorized persons to independently perform their duties without interference from the person in charge of the enterprise and other personnel. Article 21 The person in charge of the enterprise The person in charge of the enterprise is the main person responsible for the quality of pharmaceutical products, and is fully responsible for the day-to-day management of the enterprise. In order to ensure that the enterprise to achieve the quality objectives and production of drugs in accordance with the requirements of this specification, the person in charge of the enterprise shall be responsible for providing the necessary resources, reasonable planning, organization and coordination, to ensure that the quality management department to independently perform their duties. Article 22 The person in charge of production management (A) Qualifications: The person in charge of production management shall have at least a bachelor's degree in pharmacy or related majors (or intermediate professional and technical title or licensed pharmacist qualification), with at least three years of practical experience in drug production and quality management, of which at least one year of experience in drug production management, and has received professional knowledge training related to the products produced. (II) Main Duties: Article 23 The person in charge of quality management (A) Qualifications: The person in charge of quality management shall have at least a bachelor's degree in pharmacy or related majors (or an intermediate professional and technical title or a licensed pharmacist qualification) with at least five years of practical experience in pharmaceutical production and quality management, of which at least one year's experience in pharmaceutical quality management, and have received training in professional knowledge related to the products being produced. (ii) Main duties: Article 24 The person in charge of production management and the person in charge of quality management usually have the following ****same duties: Article 25 Quality authorized person (a) Qualifications: The quality authorized person shall have at least a bachelor's degree in pharmacy or related majors (or an intermediate professional and technical title or the qualification of a practicing pharmacist), have at least five years of practical experience in drug production and quality management, and have been engaged in the process of drug production control and quality inspection work. The quality authorized person shall have the necessary professional theoretical knowledge and training related to product release before he/she can independently perform his/her duties. (ii) Main duties: Section III Training
Chapter IV Plant and Facilities
Section I Principles Section II Production Areas Article 46 In order to reduce the risk of contamination and cross-contamination, plants, production facilities and equipment shall be reasonably designed, laid out and used in accordance with the characteristics of the pharmaceutical products to be produced, the technological process and the corresponding requirements for the level of cleanliness and shall comply with the following requirements: Article 47 The production and storage areas shall have sufficient space to be used for the production of pharmaceutical products, and shall have sufficient space to be used for the production of pharmaceutical products. The storage area shall have enough space to ensure orderly storage of equipment, materials, intermediate products, products to be packaged and finished products, to avoid confusion and cross-contamination of different products or materials, and to avoid omissions or errors in production or quality control operations. Article 48 The air-conditioning purification system shall be configured according to the varieties of drugs, production operation requirements and external environmental conditions, so that the production area is effectively ventilated with temperature, humidity control and air purification and filtration to ensure that the production environment of drugs meets the requirements. The pressure difference between clean and non-clean areas and between clean areas of different levels should be not less than 10 Pascal. If necessary, the same cleanliness level of different functional areas (operating rooms) should also maintain an appropriate differential pressure gradient between. Oral liquids and solid preparations, cavity drugs (including rectal drugs), epidermal drugs and other non-sterile preparations for the production of exposed process areas and their direct contact with the final processing of pharmaceutical packaging materials exposed process areas, should be referred to in the appendix of the "sterile drugs" level D clean area requirements set up, the enterprise can be based on the standards and characteristics of the product on the Enterprises may adopt appropriate microbial monitoring measures for the area according to the standards and characteristics of the products. Article 49 The inner surface of the clean area (walls, floor, ceiling) should be smooth, no cracks, tight interfaces, no particles off, to avoid accumulation of dust, to facilitate effective cleaning, disinfection should be carried out when necessary. Article 50 The design and installation of various pipelines, lighting facilities, air vents and other utilities should avoid parts that are not easy to clean, and should be maintained as far as possible outside the production area. Article 51 The drainage facilities shall be of appropriate size and installed with devices to prevent backflow. Open ditch drainage should be avoided as far as possible; when unavoidable, the open ditch should be shallow to facilitate cleaning and disinfection. Article 52 The weighing of raw and auxiliary materials for preparations shall normally be carried out in a specially designed weighing room. Article 53 The dust-producing operation room (such as dry materials or products, sampling, weighing, mixing, packaging and other operations) should maintain a relative negative pressure or take special measures to prevent the spread of dust to avoid cross-pollution and facilitate cleaning. Article 54 The plant or area used for pharmaceutical packaging should be reasonably designed and laid out to avoid confusion or cross-contamination. If there are several packaging lines in the same area, there should be segregation measures. Article 66 The laboratories handling biological samples or radioactive samples and other special items shall comply with the relevant national requirements. Article 67 The laboratory animal room shall be strictly separated from other areas, and its design and construction shall comply with the relevant state requirements, with independent air treatment facilities as well as special access for animals. Section V Auxiliary areas Article 68 The setting of lounges shall not adversely affect the production area, storage area and quality control area. Article 69 Changing rooms and lavatories shall be easily accessible and appropriate to the number of people using them. The washroom shall not be directly connected with the production area and storage area. Article 70 The maintenance room should be as far away as possible from the production area. Stored in the clean area of the maintenance of spare parts and tools, should be placed in a special room or tool cabinet.
Chapter V Equipment
Section I Principles Article 71 The design, selection, installation, modification and maintenance of equipment must be consistent with the intended use, should minimize the generation of contamination, cross-contamination, confusion and the risk of error, to facilitate the operation, cleaning, maintenance, as well as the necessary disinfection or sterilization. Article 72 shall establish operating procedures for the use, cleaning, maintenance and repair of equipment, and keep corresponding operation records. Article 73 Documents and records of equipment procurement, installation and confirmation shall be established and kept. Section II Design and Installation Article 74 The production equipment shall not have any adverse effect on the quality of drugs. The surface of the production equipment in direct contact with drugs shall be flat, smooth, easy to clean or disinfect, corrosion-resistant, and shall not have chemical reaction with drugs, adsorb drugs or release substances into drugs. Section V Calibration Article 90 The production and inspection scales, gauges, meters, recording and control equipment and instruments shall be calibrated and inspected regularly in accordance with operating procedures and calibration plans, and relevant records shall be kept. The range of calibration shall cover the actual production and inspection scope of use. Article 91 shall ensure that the key weights and measures, meters, instruments, recording and control equipment and apparatus used for production and inspection are calibrated, and the resulting data are accurate and reliable. Article 92 should be calibrated using measurement standards, and the measurement standards should be used in accordance with relevant state regulations. Calibration records should be marked with the name of the measuring instruments used, number, calibration period and measurement of the certificate of conformity number to ensure the traceability of records. Article 93 of the balance, gauges, meters, equipment used for recording and control, as well as instruments should be clearly marked, indicating the validity of its calibration. Article 94 shall not use uncalibrated, more than the calibration validity period, out of calibration scales, gauges, meters and equipment and instruments for recording and control. Article 95 In the production, packaging, warehousing process using automatic or electronic equipment, should be in accordance with the operating procedures for regular calibration and inspection to ensure that its operational function is normal. Calibration and inspection should have the appropriate records. Section VI Pharmaceutical Water Article 96 The pharmaceutical water shall be suitable for its purpose, and in accordance with the quality standards of the Chinese People's *** and the State Pharmacopoeia and related requirements. Pharmaceutical water should be used at least drinking water. Article 97 The design, installation, operation and maintenance of water treatment equipment and its delivery system shall ensure that pharmaceutical water meets the set quality standards. The operation of water treatment equipment shall not exceed its design capacity. Article 98 The purified water, water for injection tanks and piping materials used should be non-toxic, corrosion-resistant; tanks should be installed in the air vent does not shed fibers of the hydrophobic sterilization filter; piping design and installation should be avoided dead ends, blind tube. Article 99 The preparation, storage and distribution of purified water, water for injection should be able to prevent the growth of microorganisms. Purified water can be used cycle, water for injection can be used above 70 ℃ insulation cycle. Article 100 The pharmaceutical water and raw water quality should be regularly monitored, and the corresponding records. Article 101 The purified water and water for injection pipelines should be cleaned and disinfected in accordance with the operating procedures, and there are relevant records. Pharmaceutical water microbial contamination found to reach the alert limit, corrective limit should be handled in accordance with operating procedures.
Chapter VI Materials and Products
Section I. Principles Article 102 The raw and auxiliary materials used in the production of pharmaceuticals, and packaging materials in direct contact with pharmaceuticals shall comply with the appropriate quality standards. Inks used for direct printing on pharmaceutical products shall comply with the requirements of food standards. Imported raw and auxiliary materials shall comply with the relevant national import regulations. Article 103 shall establish operating procedures for materials and products to ensure the proper receipt, storage, issuance, use and shipment of materials and products to prevent contamination, cross-contamination, confusion and error. Handling of materials and products shall be carried out in accordance with the operating procedures or process procedures, and records shall be kept. Article 104 The determination and change of material suppliers shall be assessed for quality and approved by the quality management department before procurement. Article 105 The transportation of materials and products shall be able to meet the requirements of its quality assurance, and where there are special requirements for transportation, the transportation conditions shall be confirmed. Article 106 The reception of raw and auxiliary materials, packaging materials in direct contact with drugs and printing and packaging materials shall have operating procedures, and all arriving materials shall be inspected to ensure consistency with the order and to confirm that the supplier has been approved by the quality management department. The outer packaging of the material should be labeled with the required information. Where necessary, cleaning should also be carried out and any damage to the outer packaging or other problems that may affect the quality of the material should be reported to the quality management department and investigated and recorded. Each reception shall be recorded, including the following: Article 107 Material reception and finished products after production shall be promptly managed in accordance with the pending inspection until release. Article 108 The materials and products should be according to its nature of orderly batch storage and turnover, issuance and shipment should be in line with the principle of first-in-first-out and near-expiry first-out. Article 109 The use of computerized warehouse management, there should be appropriate operating procedures to prevent system failure, downtime and other special circumstances caused by confusion and errors in materials and products. The use of fully computerized warehouse management system for identification, materials, products and other relevant information may not have to be marked in a written readable way. Section II raw and auxiliary materials Article 110 shall formulate appropriate operating procedures, take appropriate measures such as checking or inspection to confirm that the raw and auxiliary materials in each package are correct. Article 111 of the materials received several batches at a time, should be sampled by batch, inspection, release. Article 112 The storage area of raw and auxiliary materials should be properly labeled, and at least the following: (a) the designated name of the material and the enterprise's internal material code; (b) the enterprise to receive the set batch number; (c) the quality of the material status (such as pending inspection, qualified, unqualified, has been sampled); (d) the expiration date or re-inspection period. Article 113 (a) product name and product code within the enterprise; (b) product lot number; (c) quantity or weight (such as gross weight, net weight, etc.); (d) production process (if necessary); (e) product quality status (if necessary, such as to be inspected, qualified, unqualified, has been sampled). Section IV Packaging Materials Article 120 The management and control requirements for packaging materials and printing packaging materials in direct contact with drugs are the same as those for raw and auxiliary materials. Article 121 Packaging materials should be issued by specialized personnel in accordance with operating procedures, and take measures to avoid confusion and errors, to ensure that the packaging materials used for the production of drugs is correct. Article 122 shall establish operating procedures for the design, review and approval of printed packaging materials, to ensure that the contents printed on the printed packaging materials are consistent with those approved by the drug supervision and management department, and to establish a special file to preserve the actual samples of the original signed and approved printed packaging materials. Article 123 When the version of printed packaging materials changes, measures should be taken to ensure that the version of printed packaging materials used in the product is correct. It is appropriate to recover the old printing templates for scrapping and be destroyed. Article 124 The printed packaging materials shall set up a special area for proper storage, unauthorized personnel shall not enter. Cutting labels or other bulk printing packaging materials should be placed in closed containers for storage and transportation to prevent confusion. Article 125 The printing packaging materials shall be kept by specialized personnel and issued in accordance with the operating procedures and demand. Article 126 Each batch or each issue of packaging materials or printing packaging materials that are in direct contact with drugs shall have an identification mark indicating the name and batch number of the products used. Article 127 Expired or discarded printing and packaging materials shall be destroyed and recorded. Section V finished products Article 128 The finished product should be tested before release for storage. Article 129 The storage conditions of the finished product should be in line with the requirements of drug registration approval. Section VI special management of materials and products Article 130 narcotic drugs, psychotropic drugs, toxic drugs for medical use (including herbs), radioactive drugs, drugs, drug-type chemicals and flammable, explosive and other hazardous materials, acceptance, storage, management should be implemented in accordance with relevant state regulations. Section VII Other Article 131 Unqualified materials, intermediate products, products to be packaged and finished products should have a clear and conspicuous mark on each packaging container, and properly stored in the quarantine area. If the returned products are recycled, the recycled products shall comply with the predetermined quality standards and the requirements of Article 133. The process and results of return processing should be recorded accordingly.
Chapter VII Confirmation and Verification
Article 138 The enterprise shall determine the confirmation or verification work that needs to be carried out in order to prove that the key elements of the operation concerned can be effectively controlled. The scope and extent of the validation or verification shall be determined by a risk assessment. Article 139 The plant, facilities, equipment and inspection instruments of an enterprise shall be validated, and validated production processes, operating procedures and inspection methods shall be adopted for production, operation and inspection, and a continuous validation status shall be maintained. Article 140 Documents and records of confirmation and validation shall be established, and the following predetermined objectives can be proved by documents and records to be achieved: Article 141 Before adopting a new production prescription or production process, the applicability of its routine production shall be verified. The production process shall be capable of consistently producing a product that meets the intended use and registration requirements under the conditions of using the specified raw and auxiliary materials and equipment. Article 142 When the main factors affecting product quality, such as raw and auxiliary materials, packaging materials in direct contact with pharmaceutical products, production equipment, production environment (or plant), production process, testing methods and so on change, it shall be confirmed or verified. If necessary, it shall also be approved by the drug supervision and management department. Article 143 The cleaning method should be verified to confirm the effectiveness of its cleaning to effectively prevent contamination and cross-contamination. Cleaning validation shall take into account the use of equipment, cleaning agents and disinfectants used, sampling methods and locations and the corresponding sampling recovery rate, the nature and limits of residues, the sensitivity of residue testing methods and other factors. Article 144 Confirmation and validation are not one-time acts. After the first confirmation or validation, re-confirmation or re-validation shall be carried out based on the retrospective analysis of product quality. Key production processes and operating procedures should be periodically revalidated to ensure that they can achieve the desired results. Article 145 The enterprise shall formulate a validation master plan to document the key information of the confirmation and validation work. Article 146 The validation master plan or other relevant documents shall make provisions to ensure that the plant, facilities, equipment, testing instruments, production processes, operating procedures and testing methods can maintain continuous stability. Article 147 The confirmation or verification program shall be formulated according to the object of confirmation or verification, and be reviewed and approved. Confirmation or verification program should be clear responsibilities. Article 148 The confirmation or verification should be implemented in accordance with the predetermined and approved program, and have records. After the confirmation or verification work is completed, a report shall be written and reviewed and approved. The results and conclusions (including evaluations and recommendations) of the confirmation or verification shall be recorded and archived. Article 149 shall be based on the results of the verification to confirm the process procedures and operating procedures.
Chapter 8 Documentation Management
Section 1 Principles Article 150 Documentation is a basic element of the quality assurance system. Enterprises must have the correct content of the written quality standards, production prescriptions and process procedures, operating procedures and records and other documents. Article 151 Enterprises shall establish operating procedures for document management and systematically design, formulate, review, approve and issue documents. Documents related to this specification should be reviewed by the quality management department. Article 152 The content of the documents shall be consistent with the drug production license, drug registration and other related requirements, and help trace the history of each batch of products. Article 153 The drafting, revising, reviewing, approving, replacing or withdrawing, copying, storing and destroying of documents shall be managed in accordance with the operating procedures, and there shall be corresponding records of distribution, withdrawal, copying and destruction of documents. Article 154 The drafting, revision, review and approval of documents shall be signed and dated by appropriate personnel. Article 155 Documents shall be labeled with the title, type, purpose as well as document number and version number. The text shall be precise, clear and easy to understand, and shall not be ambiguous. Article 156 documents should be categorized and stored in a clear and organized manner, so as to facilitate access. Article 157 The original version of the document reproduction, shall not produce any error; reproduction of the document should be clear and legible. Article 158 Documents shall be regularly reviewed and revised; after the revision of the documents, they shall be managed in accordance with the provisions to prevent the misuse of the old version of the documents. Documents distributed and used shall be the approved current version; withdrawn or old versions of documents shall not be present at the work site except for keeping them in the file for inspection. Article 159 Each activity related to this specification shall be recorded to ensure that product production, quality control and quality assurance activities can be traced. Records should be left to fill in the data enough space. Records should be filled out in a timely manner, the content is true, clear handwriting, easy to read, not easy to erase. Article 160 should be used as far as possible production and inspection equipment to automatically print the records, charts and graphs, etc., and indicate the name of the product or sample, batch number and record the information of the equipment, the operator should sign the name and date. Article 161 The records shall be kept clean and shall not be torn or arbitrarily altered. Records should be filled in any changes should be signed name and date, and so that the original information is still legible, if necessary, should explain the reasons for change. If the records need to be re-transcribed, the original records shall not be destroyed and shall be kept as an attachment to the re-transcribed records. Article 162 Each batch of drugs shall have batch records, including batch production records, batch packaging records, batch inspection records and drug release audit records and other records related to the batch of products. The batch records shall be managed by the quality management department, and kept for at least one year after the expiration date of the drugs. Other important documents such as quality standards, process protocols, operating procedures, stability investigation, confirmation, verification, change and so on shall be kept for a long time. Article 163 If the use of electronic data processing systems, photographic technology or other reliable way to record data and information, there should be the operating procedures of the system used; the accuracy of the record should be verified. Where an electronic data-processing system is used, only authorized personnel may enter or change data, and changes and deletions shall be recorded; passwords or other means shall be used to control access to the system; and the entry of key data shall be independently reviewed by others. Batch records kept electronically should be backed up by magnetic tape, microfilm, paper copies, or other means to ensure that the records are secure and that the data are easily accessible during the retention period. Section 2 Quality standards Article 164 Materials and finished products shall have approved and current quality standards; where necessary, intermediate products or products to be packaged shall also have quality standards. Article 165 The quality standards of materials shall generally include: (1) Basic information of materials: (2) Sampling, testing methods or relevant operation procedure numbers; (3) Qualitative and quantitative limit requirements; (4) Storage conditions and precautions; (5) Expiry date or re-examination period. Article 166 The purchased or exported intermediate products and products to be packaged should have quality standards; if the test results of intermediate products for the quality assessment of the finished product, it should be formulated with the finished product quality standards corresponding to the quality standards of intermediate product quality standards. Article 167 The quality standards of finished products shall include: (1) product name and product code; (2) corresponding product prescription number (if any); (3) product specifications and packaging form; (4) sampling, testing methods or relevant operation procedure number; (5) qualitative and quantitative limit requirements; (6) storage conditions and precautions; (7) expiration date. Section III Technology Regulations Article 168 Each production batch of each type of drugs should be approved by the enterprise process procedures, different drug specifications of each packaging form should have their own packaging operation requirements. The formulation of technology regulations shall be based on the registered and approved technology. Article 169 The technology program shall not be changed arbitrarily. If changes are required, they shall be revised, reviewed and approved in accordance with the relevant operating procedures. Article 170 The contents of the process regulations of the preparation shall at least include: (1) production prescription: 1. product name and product code; 2. product dosage form, specifications and batch size; 3. the list of raw and auxiliary materials used (including those used in the process of production, but not in the finished product), stating the designated name, code and dosage of each material; such as raw and auxiliary materials need to be discounted when the dosage should be calculated, but also explain the method of calculation. (B) the production operation requirements: 1. The production site and the equipment used in the description (such as the location of the operating room and number, cleanliness level, the necessary temperature and humidity requirements, equipment type and number, etc.); 2. Preparation of key equipment (such as cleaning, assembly, calibration, sterilization, etc.) adopted by the method or number of the corresponding operating procedures; 3. Detailed description of the production steps and process parameters (such as verification of the material, pre-treatment, Detailed production steps and process parameters (such as material checking, pretreatment, the order of adding materials, mixing time, temperature, etc.); 4. All intermediate control methods and standards; 5. Expected final yield limits, if necessary, should also indicate the limits of intermediate product yield, as well as the method of calculating the balance of materials and the limits; 6. To be packaged products, storage requirements, including containers, labels, and special storage conditions; 7. Precautions need to be explained. (C) packaging operation requirements: Section IV Batch Production Records Article 171 Each batch of products should have the appropriate batch production records, traceable to the production history of the batch of products as well as with the quality