1. Purpose: Establish a code of conduct that QC personnel need to abide by in the laboratory, and provide a standard procedure for the testing of raw materials, finished products and intermediates in order to obtain reliable data for quality inspection. 2. Scope of application: QA, QC 3. Responsibility: QA inspectors and QC laboratory technicians should strictly abide by this operating procedure. The QC supervisor and QA supervisor are responsible for supervising the implementation of this procedure.

4. Content: 4.1. Sampling 4.1.1. QA personnel will prepare sampling containers according to the inspection order, and sample finished products, semi-finished products, and raw and auxiliary materials according to regulations. Fill out the sampling form after taking the sample. Four samples are randomly selected from each batch (the volume of each sample should be at least three times the assay volume), and one sample is currently used for assay. The other three samples are used as retention samples and are stored in the retention sample room. The product name, specifications, batch number, name of the sampler, and date should be filled in on the label. 4.1.2. When QC laboratory personnel receive the inspection form and samples, they first review whether the items are completely filled in, whether the purpose of the inspection is clear, whether the sample is consistent with the inspection form, whether the raw materials and auxiliary materials submitted for inspection are accompanied by the manufacturer's qualification report, etc. When the inspection is correct, sign the inspection form. 4.1.3. Sampling should be carried out in accordance with sampling rules. After sampling, record it directly in the sampling record book (including barrel number, appearance inspection status). 4.2. Testing 4.2.1. Select the test method according to the number or name of the test item, and prepare the instruments, test solutions, standard solutions and other necessities required for the test. If the test cycle is specified, the test must be completed within the specified period. 4.2.2. Operate strictly in accordance with the prescribed testing standards, and do not change the testing method during operation. If there is a problem with the assay method, notify the QC supervisor or quality control department manager so that the problem can be solved. However, no changes to the assay method are allowed without the permission of the QC supervisor or quality control department manager. 4.2.3. When using precision instruments, you should move gently, steadily and skillfully. After using the instrument, fill in the usage record in a timely manner. Precision instruments should be inspected and calibrated according to the corresponding SOP. The instrument should only be used when it is functioning properly. If the instrument is not working properly, the user should promptly report it to the QC supervisor and department manager until the problem is solved. 4.2.4. The company's products are inspected according to various implementation standards. If the test data exceeds the error requirements specified in the method (but within the qualified limit), the QC supervisor should be notified to find out the reasons. Determine redo or retest based on the reason. 4.2.5. Original records should be made promptly and accurately during experiments. 4.2.6. After the test is completed, the used instruments should be cleaned in time to prepare them for the next technician. All glassware should be cleaned promptly after use to prevent samples from being difficult to clean after drying. Handling and testing of volatile items should be done in a fume hood. Appropriate methods should be used to handle volatile and toxic materials. 4.2.7. After the sample testing is completed, the laboratory technician should print the testing report in time, and the report should be reviewed by the QC supervisor. If the test results meet the regulations, the QC supervisor will sign and approve the test report. Laboratory technicians are responsible for errors in laboratory data and testing, and reviewers are also responsible for errors in calculations. 4.2.8. Testing should be completed in time (such as testing on intermediate products and semi-finished products ready for packaging) to avoid delaying production. 4.2.9. Complete sample testing: including timely, complete and accurate analysis of samples and completion of the testing report. 4.3. The entire process of sample testing in the laboratory report should be filled with original records. The records should be accurate, complete and timely. The specific requirements are: 4.3.1. The records should be written clearly and neatly, and any data or text errors must not be altered. , correction fluid is not allowed. You should put "____" on the wrong place, fill in the corrected data, and then sign your name and date for future reference. 4.3.2. The original record should include the name and type of the sample (batch number), the appearance of the sample, the sample weight, the quantity submitted for inspection, and the content calculation formula of the intermediate and finished product; if a reference substance is used, its weighing should be indicated. Purity, laboratory results, phenomena, laboratory technician’s conclusion and signature, calculation of auditor’s signature. 4.3.3. Accuracy of various data * The significant figures for sample weighing should be consistent with the accuracy of the balance used; * The number of ml consumed by the standard solution should be read as 0.01ml. *In the process of data processing, the "rounding to double" rule is adopted for the rounding of numbers after the significant digits. Please refer to the numerical rounding rules. *The number of significant digits in the final reported test result should be consistent with the method requirements. During the operation, the significant digits can be appropriately retained, and then rounded to the specified significant digits according to the rounding rules of significant digits, and then the rounded data are compared with the limit values ??stipulated in the standard to determine the actual index or Whether the parameters meet the standard requirements. 4.3.4. Requirements for the relative error of preparation content analysis HPLC method: ≤ 1.5% UV method: ≤ 1% Titration method: ≤ 0.5% Bioassay method: ≤ 2.5% The content of raw materials must not exceed 50% of the relative deviation of the above methods. %. 4.3.5. Laboratory report sheet. After completing the experiment, the laboratory technician should promptly issue the laboratory report and sign it. After being reviewed and signed by the reviewer, it should be submitted to the QC supervisor. The QC supervisor will judge, approve and sign based on the experimental results. 4.3.6. To fill in the finished product inspection ledger, the QA inspector should fill in the sampling date, product name, and batch number in a timely manner after taking samples. The QC supervisor will fill in the various results after the inspection as required for future reference. 4.4. Distribution and archiving of laboratory test reports 4.4.1. Original records of raw materials and excipients shall be archived by the laboratory. Report sheets are distributed to relevant departments according to specific requirements.

4.4.2. The report sheets and original records of intermediate and finished products are included in the product files, and shall be kept with the product files until at least one year after the expiry date of the finished products. The raw material report sheets shall be kept at least until the last batch made with the raw materials. One year after the expiry date of the finished product. 4.4.3. If the laboratory test sheet needs to be removed from the file, the person who removed it must sign on the file management record book and write the date of removal and return. If you need a copy of this report, it must be approved by the QC supervisor and quality control department manager before copying, and the copy should be stamped with the "Quality Control Department" seal. 4.5 Problem Feedback Procedure If quality problems or anomalies are discovered during the inspection process, feedback should be given step by step in a timely manner, and the cause should be jointly found and handled properly. The party concerned will be responsible for the consequences of concealing quality problems or inspection accidents or even committing fraud. . QC is the abbreviation of QUALITY CONTROL in English. The Chinese meaning is quality control. Its definition in ISO8402:1994 is "the operating techniques and activities adopted to meet quality requirements."

Some organizations that implement ISO9000 will set up such a department or position to be responsible for the quality control functions required by the ISO9000 standard. Those who perform such work are called QC personnel, which is equivalent to product inspectors in general enterprises, including incoming inspectors. (IQC), in-process inspector (IPQC) and final inspector (FQC)