Basic knowledge of standard operating procedures (SOP) \x0d\ SOP is an important part of all kinds of standardized management certification and product certification, and all industries have requirements for SOP. What is SOP? Simply put, SOP is a comprehensive set of operating instructions. Good SOP is a necessary condition to ensure the quality of products or services. SOP is not only a set of technical models, but also covers management ideas, management concepts and management means. Because mature industries have clear management norms and certification systems, the standardization and maturity of their SOPs are relatively high, and it is difficult to have evidence to compile SOPs. Because there is no mature laboratory management and certification system at present, it is a bit blind to write SOP in inspection work. \x0d\ First of all, SOPs have industry characteristics, and different industries have different SOPs. As far as inspection work is concerned, instruments and reagents have SOPs, and each item has its own different SOPs, not to mention that bacteria and biochemical immunity also have different SOPs, that is, different items in the same subject also have different SOPs. Therefore, the inspection SOP is not one, but a set. \x0d\ Second, SOP covers everything, that is to say, as long as it is related to the project, it should be detailed and comprehensive, including all possible details. Taking the pilot's operating rules as an example, the first competition is "sitting down", which shows the meticulous coverage of SOP. SOP is not a simple operation instruction, but a practical operation encyclopedia, which should be a reference book. An ideal SOP should make an ignorant person become an expert after learning. \x0d\ Thirdly, SOP is not only a detailed work instruction, but also a part of management norms, which also contains the concept of quality control and management, and even the staffing can be seen from it. \x0d\ Although the specific contents of SOPs in different industries are different, they are logically related, so it is very valuable to learn from the particularly similar SOP requirements in other industries. Take pharmaceutical production SOP as an example, its requirements are required by GMP certification. According to GMP, the emphasis of its SOP is attached. \x0d\ Learn the main points of drug SOP, check SOP\x0d\ Edit this paragraph \x0d\ 1, operating rules: operating rules of experiments and instruments, access and post-experiment treatment of experimental instruments, cleaning of experimental platform, treatment of experimental substance overflow, etc. \x0d\ 2. Quality control: quality monitoring of experiments and instruments, such as experiments. ), instrument calibration (personnel, time, methods, etc. ), maintenance, original records of experiments, etc. The original record of the experiment is very important. Besides patient data, the important means to find and solve problems should also include environmental parameters (weather conditions, temperature and humidity, etc.). ), the instrument used, the nature and quality of the sample, the manufacturer and batch number of the reagent, the quality control results of the same batch and the treatment methods (such as re-inspection, re-pumping, and sending reports). , as detailed as possible. \x0d\ 3。 Judgment and handling of abnormal results: indicators for judging abnormal results, methods and procedures for analyzing and handling reasons. For example, is it an abnormal result or an experimental error or mistake? How to judge? What is the normal range of samples? If the specimens with abnormal range are handled, will they be re-examined or contacted with clinic more or less? \x0d\ 4。 Process: it should include the sending and receiving of samples, the sending and receiving of reports, the handling of quality and instrument problems and so on. There should be clear technological procedures. Such as who receives the specimen, who sends the report, how long it takes to receive it, how long it takes to send it, to whom it is received, and the procedures for reporting instrument failures. \x0d\ 5。 Quality index, acceptance and storage of reagents and samples: who will enter, who will test, how to store, and whether the storage quality is guaranteed. Such as: who will monitor the temperature of the storage refrigerator, who will give an early warning when the reagent fails, and how often to replant the standard bacteria. \x0d\ 6。 Personnel responsibilities: personnel responsibilities are clearly reflected in the process, such as who to report to, who to handle, who to review the report, what kind of abnormal experiment operators to handle, what kind of situation to report to the supervisor, etc. Of course, it is better to have personnel training SOP. \x0d\ Inspection SOP can take instrument operation manual and reagent instruction as blue books, and add upstream and downstream contents according to the situation of departments, such as sample collection and processing, abnormal result processing, etc., which can be used as project or instrument SOP. The SOP of each project is basically completed by SOP of sample collection, report distribution, reagent purchase, acceptance and warehousing, and distribution. \x0d\ Key contents of SOP for pharmaceutical production \x0d\ Edit this paragraph \x0d\ 1 deviation handling \x0d\ Explain in detail the time and method that may deviate from the expected results and conclusions, such as the yield is beyond the expected range, the product does not meet the specifications, the reaction conditions do not meet specific parameters, and the equipment standards are unqualified. Scientific experiment demonstration, approval, etc. \x0d\ 2 Internal Audit \x0d\ Describe as clearly as possible how, when and by whom to conduct internal audit, why to conduct internal audit, and what methods and procedures to adopt. \x0d\ 3 External audit \x0d\ describes the frequency and reasons for auditing suppliers (raw materials, packaging materials, etc.). ) and the agreement (contract) used. The simplest and clearest way is to ask the supplier to fill out a self-made form including the above contents and go through the examination and approval procedures. \x0d\ 4 Quality audit procedure \x0d\ describes how and by whom to audit and approve batch records, process inspection and final API inspection data, and the quality assurance department (QA) must be ultimately responsible for these data before the finished products enter the market. \x0d\ 5 Personnel sent to the production department to conduct intermediate process tests \x0d\ describe the procedures and standards that must be met to allow production personnel to conduct intermediate process tests, such as checking the PH value of the solution before extraction. \x0d\ 6 Quality Standards \x0d\ describes the personnel, departments and procedures responsible for reviewing and approving the quality standards of new raw materials, intermediates and drugs. If the quality standard changes, the review and approval of the procedure shall also be described in this standard operating procedure. \x0d\ 7 Approval of inspection procedures \x0d\ Describe the personnel, departments and inspection procedures responsible for inspection procedures. This inspection procedure can be the national legal standard, such as the inspection procedure of China Pharmacopoeia, United States Pharmacopoeia and National Pharmacopoeia, but if this procedure does not exist or is not suitable for specific raw materials, other relevant inspection methods can be used. \x0d\ 8 Approval Specification for Process Control \x0d\ Specification describing the decisive procedure of process control inspection. \x0d\ 9 Verification Manual and Report \x0d\ describes the provisions of the release, review and approval process verification manual and report. \x0d\ 10 change control \x0d\ describes the work, review and approval procedures that must be completed when the process, inspection method, in-process inspection and equipment are changed or will be changed. \x0d\ 1 1 sampling procedure \x0d\ describes how to notify the quality control department and how to collect, identify and transport samples to the quality control room. \x0d\ 12 approval of reference materials \x0d\ describes the personnel and departments that select and approve reference materials according to relevant technological processes. \x0d\ 13 analysis, research and evaluation \x0d\ describes the personnel and departments that select and approve the analysis, research and evaluation of related technological processes. \x0d\ 14 approval of test articles \x0d\ describes the personnel and departments that select and approve test articles according to relevant technological processes, including relevant laboratory reports. \x0d\ 15 \x0d\ describes how to test and use intermediates produced by third parties. \x0d\ 16 stability test \x0d\ describes the stability test procedure, including conditions, frequency, data review and documents. \x0d\ 17 evaluation and approval of contractors \x0d\ describes how to select, evaluate and approve contractors, such as entrusting external inspection when internal inspection is impossible. \x0d\ 18 batch record review \x0d\ describes the review and signing methods and personnel of production records. \x0d\ 19 complaint review \x0d\ describes the handling process of customer complaints from acceptance to evaluation, and finally to reply. \x0d\ 20 Use of materials exceeding specifications \x0d\ describes when materials exceeding specifications are allowed to be used and what the approval procedures include. \x0d\ 2 1 Use of returned materials \x0d\ describes what must be done when using returned materials and when it is acceptable or unacceptable. \x0d\ 22 Periodic review of SOP \ x0d \ describes the review frequency of SOP (usually every two years), reviewers and those who participate in the approval of the review process. \x0d\ 23 Establishment of training records \x0d\ describes who received the training, what kind of training they received, who received the training, and where the training documents are kept. \x0d\ 24 Procurement, receipt, inspection and storage of raw materials, intermediates, packaging materials and drugs \x0d\ describes how all materials are arranged and when they are received, inspection procedures (such as labeling), storage place and method (storage place is separated from qualified materials, such as waiting area) and relocation after inspection (qualified area or unqualified area). The restocking and identification steps also apply to intermediates and drugs. \x0d\ 25 Disposal of nonconforming materials \x0d\ describes how nonconforming materials are returned to suppliers (for example, suppliers are notified and documents are prepared when purchasing) and where they are stored before shipment. \x0d\ 26 Label control \x0d\ describes how labels are printed, stored, controlled and transported to production departments and other relevant departments when necessary. (Note: The area where labels are stored must be avoided, and the number of labels must be strictly controlled. ) \x0d\ 27 Work clothes replacement \x0d\ Describe who must change into work clothes (for example, operators wear uniforms and supervisors wear laboratory clothes), when and where to change clothes, and how often to distribute and change work clothes. \x0d\ 28 Control of air supply and water supply system \x0d\ Describe the use frequency of ventilation and all water supply systems, who is responsible for the inspection, and what the inspection content is (including its process, deionized water meeting the specifications of microbial analysis and endotoxin). \x0d\ 29 Laboratory and production area piping system identification \x0d\ describes the system used to identify all laboratory and production area piping, which can be a combination of color codes, arrows, written instructions, labels, etc. \x0d\ 30 Cleaning Procedures for Production Equipment, Appliances and Containers \x0d\ describes the verified and approved methods for cleaning each piece of equipment. If the procedure for cleaning several reaction tanks is the same, the procedure describing this cleaning can include cleaning all reaction tanks. ) \x0d\ 3 1 Maintenance of production equipment \x0d\ Describe what each Takuwa needs to do to maintain the normal operation of the equipment. It is necessary to make a record of each piece of equipment and explain what was done at the last maintenance time and who maintained it. ) \x0d\ 32 Protection and inspection of equipment use \x0d\ describes how the equipment that is idle between uses is kept, and the inspection that must be carried out before reuse, and also records the longest idle time (no more than 10 days or it is necessary to clean it again). \x0d\ 33 Cleaning verification procedures \x0d\ describes how to formulate cleaning verification procedures, who will review and approve them, and where documents and records are kept. (The content should include the interval frequency of residue, detergent and biological load control. ) \x0d\ 34 equipment calibration \x0d\ describes what equipment is calibrated, how often it is reviewed, who calibrates it, how to mark it, and where the records are kept. \x0d\ 35 Unused or unqualified equipment \x0d\ describes how to identify equipment, which is not used because it is unqualified after verification and needs repair and maintenance. \x0d\ 36 Verification of computer systems \x0d\ specifies some standards when computer systems are used in production and need to be verified. The main contents to be verified include: the operation of the system, measures taken to prevent faults, error check, record correction, restart and data recovery, change permission, change record, electronic signature, accurate check of manually entered data, data backup, user rights, etc. \x0d\ 37 Equipment Log \x0d\ is used to describe which equipment is used and which products are produced. Note: This is unnecessary for special equipment. These contents have generally been included in the batch production records. \x0d\ 38 Preservation of major production and control records \x0d\ describes how to preserve and control major production records (blank batch records) and analysis records (quality control inspection procedures), and requires that major production records should be kept in appropriate places by the Quality Assurance Department. \x0d\ 39 Preservation of complete production and control records \x0d\ describes how to preserve complete production records (complete batch records) and analysis and test records (analysis reports), and requires that complete batch records and analysis and test reports should be preserved and controlled by the Quality Assurance Department. \x0d\ 40 Re-inspection cycle of all raw materials and intermediates \x0d\ specifies the frequency and types of raw materials that must be re-inspected. For example, after hydrochloric acid is qualified, the approval is valid for two years. If all the materials have not been used up by then, the rest must be rechecked before use. After passing, it can be postponed, otherwise it will be invalid. \x0d\ 4 1 multi-batch product mixing \x0d\ describes how to mix multi-batch products. In case of mixed batch, each batch must pass all standard parameters before it can be mixed with other batches of products. Mixing multiple batches of APIs should be avoided unless absolutely necessary. \x0d\ 42 API Label Certification \x0d\ describes how to label finished products. A copy of the label should be included in the SOP. (The surface of the label is damaged and cannot be used. ) \ x0d \ Traceability of 43 batches of production \ x0d \ describes the system and operating procedures that can be traced when a given batch of raw materials or intermediates has problems after use. If the relevant materials are to be recovered, the system needs to be more rigorous. \x0d\ 44 Re-sampling and reinspection of unqualified raw materials, intermediates and APIs \x0d\ Explain in detail under what circumstances raw materials, intermediates or APIs will be reinspected once they are found unqualified, including how to reinspect and allow them to be reused. \x0d\ 45 Verification of analytical methods \x0d\ Describe the characteristics that should be considered when verifying analytical methods, including accuracy, precision, specificity, detection limit, quantitative limit, linearity, range and universality. \x0d\ 46 Notify customers of changes in established production and process control regulations \x0d\ Describe how and when to notify customers if established production and control regulations are about to change or are expected to change. It should be noted that minor changes, major changes and major changes should be distinguished. \x0d\ 47 Inspection of rework API and issuance of certificate \x0d\ It is necessary to analyze any differences when inspecting and passing the rework API. For example, critically analyze and evaluate the standards that lead to API disqualification. \x0d\ 48 Mixing newly prepared and recovered solvents \x0d\ describes how to store and use newly prepared and recovered solvents. It is very inappropriate to mix the newly prepared and recovered solvents in the storage barrel. They can only be used in a batch of products, and can only be used as qualified products according to their respective specifications before use. \x0d\ 49 Recovery of API \x0d\ describes what must be done and who to notify when it is decided that it must be recovered. \x0d\ 50 Drugs for clinical trials \x0d\ describes the quality control measures adopted in the production of drugs for clinical trials and the contents of good manufacturing practice (GMP). Note: The quality standard is the same as the medicinal raw materials used in regular production.