Standard operation regulations (SOP) are important contents of various standardized management certifications and product certification, and all industries have SOP requirements. What is SOP? To put it simply, SOP is a set of containing operation manuals. A set of SOP is a necessary condition for ensuring product or service quality. SOP is not just a technical model, it also covers management ideas, management concepts and management methods. Because there are clear management specifications and certification systems in mature industries, the standardization and maturity of its SOP are relatively high, and the writing of SOP is also difficult to be based on the difficulty. Since there is no mature laboratory management and certification system, writing SOP in the inspection work will be a bit blind.
First of all, SOP has industry characteristics, and different industries have different SOPs. As far as the inspection work is concerned, the instrument has the SOP of the instrument, the reagent has the SOP of the reagent, and each project has its own different SOP, let alone the different SOPs of bacteria and biochemical immune. SOP. So test SOP is not one, but a set.
The second, SOP has no fineness, that is, as long as it is related to the project, it must be detailed and comprehensive, including all possible details. Taking the pilot's operating rules as an example, the first one is "sitting down", which can be seen that SOP covers the degree of details. SOP is not a simple operation description, but a practical operation, and it should be a thing of a reference book. A set of ideal SOP should make an expert after learning that you don't understand.
Third, SOP is not just a detailed operation instructions. It is part of the management specifications. It also contains the concept of quality control and management. From this, you can even see the personnel configuration.
The specific content of different industries SOP is different, but it has a certain logical connection. Therefore, it is very valuable to learn from the SOP requirements of other industries in other industries. Take drug production SOP as an example. The requirements are required by GMP certification. According to GMP, the focus of SOP is attached.
The focus of drawing on the SOP of the drug, testing SOP should include:
1, operating procedures: the operation procedures of experiments and instruments, the use of experimental instruments and the processing of experiments, after experimental processing, the processing of the experiment, the processing of the experiment, the processing of the experiment, the processing of the experiment, the processing of the experiment, the processing of the experiment, the processing of the experiment, The cleaning of the experimental table, the treatment of the leakage of the experiment
2, quality control: the quality monitoring of experiments and instruments, as if the number of quality control (high, medium, low?) , Time, method, etc.), maintenance and maintenance, original records of experiments, etc.实验原始记录很重要，发现问题和解决问题的重要手段，除病人资料外，还应有环境参数（天气情况、温湿度等）、使用仪器及仪器情况、样本性状和质量、试剂厂商及批号、 The results of the same batch of quality control and processing methods (such as review, re -pumping, and issuing reports) are as detailed as possible.
3, judgment and processing of abnormal results: indicators of abnormal results, and analyzing the cause of the cause and procedure. For example, is it abnormal, or is it an experimental error or error? How to judge? What is the normal range of samples? If the non -normal range of specimens are handled, how much or less than the review or clinical connection?
4, process: It should include sample receiving and receiving, reporting and receiving review, quality and instrumentation processing, etc. There must be clear process regulations. Such as who accepts specimens, who sends reports, how much time is received, how much time is sent, who receives, and the instrument failure procedures, etc.
5, reagents and sample quality indicators, acceptance and storage: whoever enters, who is inspected, how can it be stored in the way, if the quality is preserved. Such as: who monitors the temperature of the refrigerator, who is invalidated by the reagent, and how long the standard bacteria is inoculated.
6, personnel responsibilities: The personnel responsibilities are clearly reflected in the process, such as the instrument is broken, who reports to who is reported, who handles it, reports the report, who reviews, what kind of abnormal experiment operator Treatment, what kind of supervisor and so on. Of course, some personnel training SOP is better.
The writing of SOP, you can use the instrument operating manual and reagent description as the orchid. According to the situation of the department, the upstream and downstream content, such as the sample collection processing, the processing of the abnormal results, can be used as a project or the processing of abnormal results. Instrument SOP use. SOPs such as sample collection, reporting form distribution, reagent purchase, acceptance storage, and distribution of various projects are basically completed.
The key content of drug production SOP:
There are deviations from the expected results and conclusions. For example, in addition to the expected range, the product does not meet the specifications, the reaction conditions do not meet specific parameters, the equipment standards are not qualified, etc. What are the measures, procedures, and whether it is reasonable. Scientific test demonstration, review and approval.
2 Internal audit
The as much as possible to describe how to be clear, when and who internal audit, and why internal audit, what are the methods and procedures adopted.
3 External audit
The frequency and reasons for auditing of suppliers (raw materials, packaging materials, etc.), and the linked books (contracts) used, the simplest and clear method used It is required to complete a form designed by the supplier, including the above -mentioned content, review and approval procedures.
4 Quality review procedures
describing how and who is reviewed and approved for approval records, inspection during process, and the final API inspection data. The warranty department (QA) must be right. This is the final responsibility before the finished product enters the market.
5 sent to the production department for the process of process intermediate experiments
describing the procedures and standards that allow manufacturers to perform processing in the process of process, such as checking the solution before extraction to check the solution The pH value, etc.
6 Standards for specifications
The persons, departments and procedures responsible for reviewing and approving new raw materials, intermediates and drug specifications, such as changes in specifications, the review and approval of procedures also It should be explained in this SOP.
7 The approval of the inspection procedure
The description of personnel, departments, and inspection procedures responsible for inspection procedures. The inspection regulations such as prescription sets are standards, but if such procedures do not exist or are not applicable to specific raw materials, then other relevant inspection methods can be used.
8 The approval controlled by the process regulations
The description of the rules for the decisive program used in the process of control testing.
9 verification manuals and reports
The provisions of the manual and reporting manual and report of the processing, review and approval process verification handling and approval process.
10 Change control
The description When the process of process, inspection method, inspection during process, etc. changes may be changed, the review and approval procedure that must be changed will be changed Essence
11 sampling procedures
describing how the quality control department is notified, and how to collect, identify samples and transport them to the quality control room.
12 Standardized control products Approval
The persons and departments of the relevant process and selection and approval of the control products are described.
13 Analysis and evaluation
The persons and departments that describe related processes, select and approve analysis research and evaluation.
14 The approval of test products
The description for related process processes, selected and approved personnel and departments, including relevant laboratory reports.
15 Entrusted with production substances
The description If the intermediate is produced and used in the intermediate when produced by a third party.
16 Stability test
describing stability test procedures, including conditions, frequency, data review and file records.
17 The evaluation and approval of the contractor
The description of how to choose, evaluate and approve the contractor, such as entrusting external inspections when the enterprise cannot conduct internal inspection.
18 batch of record review
describes how the production records are reviewed and signed.
19 Complaints for complaints
describing how customer complaints from receiving evaluation and final reactions.
20 The use of materials outside the specifications
This description when it is allowed to be used outside the specifications and the content included in the approval procedure.
21 The use of returned materials
This description What must be done using the return material and when it is acceptable or unacceptable.
22 SOP's regular review
The description of how long to review the SOP (usually every two years), who is reviewed and who participates in the audit process approval.
23 The establishment of training records
This description who obtains training, what type of training they obtain, where the training and training documents are kept.
24 raw materials, intermediates, packaging materials and drugs to purchase, receive, test and storage
describing how all the materials are arranged and when they receive, check the procedure (For example, the label attached), where and how to be stored (separate from the placement of the placement and the qualified material as the inspection area) and the replacement of the qualified (qualified area or unqualified area). Re -entry and identification steps are also applicable to intermediates and medicines.
25 The processing of unqualified materials
This described materials with unqualified materials are returned to the supplier (such as notifying the supplier when buying and preparing document records). Where is the storage until it is shipped out.
26 label control
The description of how the label is printed, preserved, controlled, and is transported to relevant departments such as the production department when needed. (Note: The area where the label must be stored must ensure that the quantity of idlers cannot enter and the amount of labels must be strictly controlled.)
27 workwear replacement
describing who must put on workwear (such as operations (such as operation Personnel wear uniforms and supervisors to wear laboratory jackets), when and where to change clothes and how long they will be distributed and replaced with work uniforms.
28 The control of the air and water supply system
The description of the ventilation and all the water supply systems used every time, who is responsible for inspection and what to check (including its process, in line with it Microbial analysis and internal toxin specifications).
29 Laboratory and production regional pipeline system logo
systems that are described to identify all laboratories and production regional pipelines. Mixed use.
30 production equipment, utensils and container cleaning procedures
The method to describe the method of cleaning and approval of each piece of device. (If the procedures for cleaning a few reaction tanks are the same, then write down a regulation describing such a cleaning can contain the cleaning of all reaction tanks.)
31 The maintenance of the production equipment
The description of how long and what needs to be done to maintain the normal operation of the equipment. (Need to save the records of each device and explain what the last maintenance time is, who is repaired.)
32 The protection and inspection of the device use How the idle equipment between the two uses and the inspection that must be performed before using it again should also record the longest period of time (not more than 10 days or necessary re -cleaning).
33 Cleaning verification regulations
This description how to formulate clean verification regulations, who are reviewed and approved by whom, and where the file records are preserved. (The content should include the interval frequency of residuals, cleaner and biological load control.)
34 Equipment verification
describing what equipment does the verification, how long is the re -school every intermittent school Wheat, who is calibrated, how to be marked, and where the records are preserved.
35 The equipment that is not used or is not qualified
The description how to identify the device, which are due to unqualified after passage, need to be maintained, maintenance, etc. Essence
36 The verification of the computer system
The detailed description when the computer system is used for the production process and some standards need to be verified. The main content of the verified is: system operations, measures to prevent faults, wrong inspections, recording corrections, re -startup and data recovery, changes, recording of change, electronic signature, and accurate inspection of artificial input data. , Data backup, user permission, etc.
37 Equipment log
It to describe which equipment used and what products are produced. Note: This is unnecessary for dedicated equipment. These contents are generally included in batch production records.
38 The maintenance of the main production and control records
describing how to save and control the main production records (blank batch records) and analysis records (quality control inspection regulations). The warranty department should be preserved in the right place.
39 The preservation of complete production and control records
describing how to save complete production records (complete approval records) and analytical test records (analysis report), require complete approval Records and analysis inspection reports should be preserved and controlled by the warranty department.
40 The re -inspection cycle of all raw materials and intermediates
The detailed description of how long, which raw materials must be re -inspected. For example, after being tested and qualified, the time limit for approval is approved. If all the materials have not been used at that time, the remaining re -inspection must be performed before use. It can be extended after passing, otherwise scrapped treatment.
41 The mix of multiple batches of products
describing how to mix multiple batches of products. If mixed batches are required, then each batch must be tested and passed all standard parameters after all standard parameters. In order to mix with other batch of products. Avoid the mixing of multiple APIs, unless it is absolutely necessary.
42 API label identification
The description how to mark the finished product. In the SOP, it should include a copy of the label. (The label surface is damaged and cannot be used.)
43 batch of production can be traceable
The batch of raw materials or intermediates described Tracking system and operation procedures. To recover related materials, this system requires more stringent.
44 Once found unqualified, the reconstruction and re -inspection of the raw materials, intermediates and APIS
In the details of the case, the raw materials, intermediates or APIs are in the case Once you find unqualified re -inspection, including how to re -inspect and allow re -use.
45 Analysis of the regulations
The characteristics that should be considered when describing verification and analysis procedures, including accuracy, precision, dedicated properties, detection limit, quantitative limit, linear, scope And extension, etc.
46 notifying the customer about the change of the determined production and process control procedures
Ilvas to change if it is to be changed or expected to be changed. Notify the customer. It should be noted that small changes, big changes and key changes in differential changes.
47 The inspection and qualification certificate of the API of the rework
Masis need to be analyzed when the inspection and qualified API are re -processed. For example, key analysis and evaluation of standards that cause unqualified APIs.
48 The mix of new and recycled solvents
describing how to save and use new and recycled solvents, mix new and recycled solvents in the storage bucket bucket barrel It is very unwilling. Only when they are added in a batch of products, they can be mixed, and they must be used as qualified products according to their own specifications before use.
49 APIS recycling
The description When deciding to recover, what must be done and notify.
50 for drugs used for clinical trials
The quality control measures for clinical trial drug production and the content of the "GMP) of Drug Production Quality (GMP). Note: Quality standards are the same as those of those formally produced.
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