1）设备连续生产或阶段性生产导致设备的清洁不彻底引发风险。“H3-SO

1) The continuous production or staged production of equipment leads to the risk of incomplete cleaning of equipment. <br><br><br>"H3-SOP-41004 Production Equipment Cleaning Management Regulations" stipulates: <br>--- Aseptic equipment cleaning principles: when continuous production, the same equipment continuously processes the same sterile product, each batch should be cleaned and sterilized, especially direct contact The parts and components of the drug must be kept sterile, and the date of sterilization must be marked, and microbiological verification should be carried out if necessary. <br>--- Principles for cleaning non-sterile equipment: when the same equipment continuously processes the same non-sterile product or several batches are produced in stages, at least once a week or several batches are produced (the specific batch is determined according to the product cleaning verification) In order to prevent the accumulation and introduction of contaminants (such as degradation products and microorganisms) into the next production, it should be cleaned once in accordance with the specific product cleaning operation procedures. <br>--- The cleaning work must ensure that the residues that affect the quality of the next batch of products can be removed; if there are residues that affect the quality of the raw material medicine, the equipment must be thoroughly cleaned when the batch is changed. <br>Conclusion: The existing SOP meets regulatory requirements.

1）设备连续生产或阶段性生产导致设备的清洁不彻底引发风险。<br><br><br>“H3-SOP-41004 生产设备清洗管理规程”规定：<br>---无菌设备清洗原则：连续生产时，同一设备连续加工同一无菌产品时，每批之间要清洗灭菌，尤其是直接接触药品的部位和部件必须保证无菌，并标明灭菌日期，必要时要进行微生物学的验证。<br>---非无菌设备清洗原则：同一设备连续加工同一非无菌产品或阶段性生产连续数个批次时，至少每周或每生产几批（具体批次根据该产品清洗验证确定）后，要按具体产品的清洗操作规程全面清洗一次，防止污染物（如降解产物、微生物）的累积和带入下一生产中。<br>---清洗工作需保证能清除影响下批产品质量的残留物；如有影响原料药质量的残留物，更换批次时，必须对设备进行彻底的清洁。<br>结论：现有SOP符合法规要求。

1) The continuous or staged production of the equipment leads to the risk of incomplete cleaning of the equipment.<br>"H3-sop-41004 production equipment cleaning management procedure" stipulates:<br>---Cleaning principle of sterile equipment: during continuous production and continuous processing of the same sterile product by the same equipment, each batch shall be cleaned and sterilized, especially the parts and components directly contacting the drug must be sterile, and the sterilization date shall be marked, and microbiological verification shall be carried out if necessary.<br>---Cleaning principle of non sterile equipment: when the same equipment continuously processes the same non sterile product or produces several consecutive batches in stages, at least once a week or every several batches (the specific batch shall be determined according to the cleaning verification of the product) shall be cleaned according to the cleaning operation procedures of the specific product to prevent the accumulation and introduction of pollutants (such as degradation products and microorganisms) into the next production 。<br>---The cleaning work shall ensure that the residues affecting the quality of the next batch of products can be removed; if there are residues affecting the quality of API, the equipment must be thoroughly cleaned when the batch is replaced.<br>Conclusion: the existing SOP meets the requirements of the regulations.<br>