本次偏差发生的根本原因是请验人员由于该产品一直没生产（特殊类产品预防交

The root cause of this deviation is that the inspector has forgotten because the product has not been produced (special products prevent cross-contamination, only tested once a year), and was not filled in in time before the production of letrozole (B process south line) H0-SOP-60006-R05 "Checklist for Cross-Contamination Prevention of Special Products" resulted in failure to monitor environmental pollutants in the general area of ​​letrozole (B process south line) products in 2019. <br><br>Check the south line of Building Y38 in workshop 212. There are two products in the same line: letrozole (B process south line) and anastrozole. The two products generally use the same air purification system in the general production area and the clean area. Letrozole (South Route of Process B) involves a total of seven environmental monitoring points. The general area has not been monitored, and the Y38-02 clean area has been monitored, and the test results are not detected (ie, ND). Looking back and analyzing in 2018, letrozole (B process south line) was produced and inspected, and the test results met the requirements. At the same time, the air conditioning system, etc. are all in the validation period, and the exhaust gas treatment system maintenance records and the general area air conditioning system maintenance records have been maintained in accordance with the maintenance operation procedures, and no abnormalities have occurred. The anti-tumor business department has designated relevant personnel to collect data on the implementation of the monitoring plan at the end of each year. This year, only letrozole (B process south line) did not complete monitoring according to the monitoring plan, and other products were not omitted. The risk is low, the deviation has little impact this time, and the risk is controllable. For details, see D-TZ-API-01LE-19002-R Letrozole (B Process South Line) Environmental Pollutant Detection Deviation Survey and Risk Assessment Report. <br><br>CP-TZ-API-D-TZ-API-01LE-19002-20001: Taking this deviation as an example, organize the relevant personnel of workshop 212 to retrain 01 of H0-SOP-60006 "Special Product Management Program", emphasizing: The inspection form must be completed, reviewed and approved on time. <br>CP-TZ-API-D-TZ-API-01LE-19002-20002: Plan to draft the annual monitoring plan and monthly summary feedback form of the anti-tumor division for special products to prevent cross-contamination, and list the product monitoring plan for the next month.

The root cause of this deviation is to ask inspectors because the product has not been produced (special products to prevent cross-contamination, only once a year) and forget, in the production of Ququzol (B process south line) did not fill in time H0-SOP-60006-R05 "special products to prevent cross-contamination monitoring list", resulting in the 2019 year did not have to comequer (B process south line) products in general environmental monitoring of pollutants. <br><br>View 212 workshop Y38 south line, a total of two products together: toquer (B process south line) and Anaquzole, two products general production area and clean area using the same set of air purification system. A total of seven environmental monitoring points are involved in the rhododendron (B process south line), the general area has not yet been monitored, Y38-02 clean area has been monitored, and the test results are not detected (i.e. ND). Review and analysis in 2018, to ququ (B process south line) has been produced and carried out a request for inspection, the test results meet the requirements. At the same time, air conditioning system and so on are in the verification period, view the exhaust gas treatment system maintenance records and ordinary area air conditioning system maintenance records, have been in accordance with the maintenance operating procedures for normal maintenance, no abnormal situation. The Anti-Oncology Division has designated relevant personnel to summarize the data on the implementation of the monitoring plan for the year at the end of each year, and this year only the data of querium (B-process south line) has not been monitored according to the monitoring plan, and no other products have been missed. The risk is low, the impact of this deviation is small, and the risk is manageable. See the D-TZ-API-01LE-19002-R-R-Ququzol (B-Process South Line) Environmental Contaminant Detection Bias Survey and Risk Assessment Report.<br><br>CP-TZ-API-D-TZ-API-01LE-19002-20001: Take this deviation as an example, organize 212 workshop related personnel to retrain H0-SOP-60006 Special Product Management Procedure01, emphasizing: Please check the document must be filled in, audited and approved on time.<br>CP-TZ-API-D-TZ-API-01LE-19002-20002: Plans to draft the Annual Monitoring Plan and Monthly Summary Feedback Form for The Special Product Symon Prevention division of the Anti-Oncology Division, and to release the product monitoring plan for the next month.

The root cause of this deviation is that the inspection personnel forget that the product has not been produced (special products to prevent cross contamination, only once a year), and did not fill in h0-sop-60006-r05 inspection request form for special products to prevent cross contamination before letrozole (south line of process B) production, resulting in no general inspection of letrozole (south line of process B) products in 2019 Environmental pollutants in the area shall be monitored.<br>Check the south line of building Y38 of workshop 212, there are two products in common: letrozole (south line of process B) and anastrozole. The same air purification system is used in the general production area and clean area of the two products. Letrozole (south line of process B) involves seven environmental monitoring points in total. The general area has not been monitored, and y38-02 clean area has been monitored, and the detection results are not detected (i.e. nd). In 2018, letrozole (south line of process B) was produced and inspected, and the test results met the requirements. At the same time, the air conditioning system is in the validation period. Check the maintenance records of the exhaust gas treatment system and the air conditioning system in the common area. All of them have been maintained normally according to the maintenance and operation procedures, and there is no abnormal situation. The anti-tumor business department has designated relevant personnel to summarize the implementation of the monitoring plan at the end of each year. This year, only letrozole (south line of process B) failed to complete the monitoring according to the monitoring plan, and no other products were omitted. The risk is low, the impact of deviation is small and the risk is controllable. For details, see d-tz-api-01le-19002-r letrozole (south line of process B) environmental pollutant detection deviation investigation and risk assessment report.<br>Cp-tz-api-d-tz-api-01le-19002-20001: take this deviation as an example, organize relevant personnel of workshop 212 to retrain version 01 of h0-sop-60006 special product management procedure, emphasizing that the inspection request must be filled in, reviewed and approved on time.<br>Cp-tz-api-d-tz-api-01le-19002-20002: it is planned to draft the annual monitoring plan and monthly summary feedback form for the prevention of cross contamination of special products of the anti-tumor business division, and to discharge the next month's product monitoring plan.<br>