此次偏差的可能原因是程序中缺少“仪器清洗时或系统平衡时，应在主路和旁路

The possible reason for this deviation is the lack of the relevant regulations in the program "When the instrument is cleaned or the system is balanced, the injection valve should be switched between the main circuit and the bypass", resulting in the inside of the six-way valve of the sampler The residue of this experiment makes the peak area of ​​this experiment abnormal and the system adaptability of needle return does not meet the requirements. <br><br>1. No similar deviations have occurred in the past two years, which has no effect on the batch of products tested in the laboratory in the early stage. 2. Because the system adaptability is only used to evaluate the stability of the instrument, it does not participate in the calculation of the sample results, and the system adaptability has no effect on the response area of ​​the normalization method; batch 2089-191205 resin eluent (4) uses the normalized The RRT1.18 impurity is calculated by the single method, and the result meets the requirements. After comparing and analyzing with the adaptive pressure of the previous 8-pin system, the pressure is normal, so there is no impact on the data, and the test report is issued with the initial test data. On 3.2020.01.02, the measurement department Wang Zhi repeated the CAY-Y66-02 instrument and the test results were in line with the requirements; at the same time, the test results of the nanofiltration concentrate of the batch of micafungin sodium resin eluent met the requirements, and continued to follow up Track and analyze the quality of the batch of finished products, and further study whether this deviation will affect the quality of the finished products. 4. For the batches of products tested on the CAY-Y66-02 liquid phase instrument, no similar situation was found, so there is no risk to the historical product batches detected on the instrument. <br><br>CP-TZ-API-D-TZ-API-IP-19046-20001: 2089-191205 batch of resin eluent (4) issued a test report with initial test data. <br>CP-TZ-API-D-TZ-API-IP-19046-20002: Follow and observe the operation of the liquid phase of CAY-Y66-02 for 3 months to see if a similar situation occurs. <br>CP-TZ-API-D-TZ-API-IP-19046-20003: Revised H0-TM-23103 "Liquid Chromatograph Maintenance Regulations", adding "In flushing the instrument or balancing system, it should be in the main Switch the injection valve between the circuit and the bypass to avoid residue or crystal precipitation at the six-way valve, and train relevant personnel.

The possible cause of this deviation is the lack of "instrument cleaning or system balance, should be switched between the main road and bypass between the sample valve" related provisions, resulting in the sampler six-way valve inside the Mikafin net residue, so that the peak area of this experiment and the system adaptive needle does not meet the requirements. <br><br>1. No similar deviation occurred in the last two years, and no impact on the batch of products tested in the laboratory. 2. Because the system adaptability is only used to evaluate the stability of the instrument, does not participate in the calculation of the sample results, and the system adaptability has no effect on the naturalization response area, 2089-191205 batch resin elution (4) using the normalized method to calculate RRT1.18 impurities, the results meet the requirements, after the previous 8 needle system adaptive pressure comparison analysis, pressure is normal, so the data has no effect on the initial detection data testreport. 3.2020.01.02, the Department of Metrology Wang Zhi on THE CAY-Y66-02 instrument repeated testing, test results are in line with the requirements, while the batch of Mikafen clean sodium resin elution liquid concentrate test results meet the requirements, follow-up continue to follow up the analysis of the quality of the product, further research on whether this deviation will have an impact on the quality of the finished product. 4. The product batch detected on the CAY-Y66-02 liquid phase instrument did not find a similar situation, so there is no risk to the historical product batch detected on the instrument. <br><br>CP-TZ-API-D-TZ-API-IP-19046-20001:2089-191205 batch resin elution (4) issues a test report with initial inspection data.<br>CP-TZ-API-D-TZ-API-IP-19046-20002: Follow-up to CAY-Y66-02 liquid phase for 3 months to see if a similar situation has occurred.<br>CP-TZ-API-D-TZ-API-IP-19046-20003: Revise H0-TM-23103 Liquid Chromatograph maintenance procedures to add in daily maintenance that "when flushing the instrument or balancing system, switch the sample valve between the main and bypass, avoid residual or crystallizing at the six-pass valve" description, and train the relevant personnel.

The possible cause of this deviation is the lack of relevant regulations in the procedure that "when the instrument is cleaned or the system is balanced, the injection valve should be switched between the main circuit and the bypass", which results in the residue of micafungin in the six-way valve of the injector, which makes the peak area of this experiment abnormal and the system adaptability return needle not meet the requirements.<br>1. No similar deviation has occurred in the past two years, which has no impact on the product batch tested in the early stage of the laboratory. 2. Because the system adaptability is only used to evaluate the stability of the instrument and does not participate in the calculation of the sample results, and the system adaptability has no effect on the response area of the normalization method; 2089-191205 batches of resin eluates (4) are used to calculate rrt1.18 impurities by the normalization method, and the results meet the requirements. After the comparative analysis with the previous 8-pin system adaptability pressures, the pressures are normal, so there is no impact on the data The test report shall be issued for the initial test data. 3. On January 2, 2020, Wang Zhi of the measurement department conducted the repeatability test on cay-y66-02 instrument, and the test results were all in line with the requirements; meanwhile, the test results of the batch of micafen sodium resin eluate nanofiltration concentrate were in line with the requirements, and the quality of the batch of finished products continued to be tracked and analyzed in the future, and whether the deviation would affect the quality of the finished products was further studied. 4. No similar situation is found in the product batch tested on cay-y66-02 liquid phase instrument, so there is no risk for the historical product batch tested on this instrument.<br>Cp-tz-api-d-tz-api-ip-19046-20001:2089-191205 batch resin eluent (4) shall issue the test report based on the initial test data.<br>Cp-tz-api-d-tz-api-ip-19046-20002: follow up and observe the liquid phase operation of cay-y66-02 for 3 months to see if there is similar situation.<br>Cp-tz-api-d-tz-api-ip-19046-20003: Revised h0-tm-23103 maintenance procedures for liquid chromatograph, added the description of "when flushing the instrument or balance system, the injection valve should be switched between the main circuit and the bypass to avoid residue or crystallization at the six way valve", and trained the relevant personnel.<br>