（四）非活性成分对联合疫苗的影响在配方的开发阶段，不同的缓冲液、盐类、

(4) The influence of inactive ingredients on the combination vaccine. <br>In the development stage of the formulation, whether different buffers, salts, stabilizers (such as lactose, gelatin, sorbitol, etc.) and other chemical factors affect the safety, purity or The effectiveness of harmful interactions should be determined. <br><br>Stability and validity period <br>In the study of stability and validity period, three batches of finished products should be used to assess the stability of the product within the actual storage period to determine the validity period of the product. <br><br><br><br>Since the validity period of the vaccine is calculated from the efficacy test of the finished product, the following three aspects should also be considered for the effect of the vaccine validity period, namely, the storage time of each component during the production process and before preparation, and the combined vaccine before and after the efficacy test. Save time. <br>The start time of the effective period of the combined vaccine should be the date from the last effective efficacy test (or qualified) of the first component in the combined vaccine. <br>Determine the validity period of the combined vaccine according to the component with the shortest validity period, that is, the validity period of each component should be considered comprehensively. <br>The expiry date of the finished product should ensure that all components of the product are stable and qualified within its total expiry date (that is, the storage period before the expiration date plus the expiry date of the finished product).

(iv) Effects of inactive ingredients on the combined vaccine<br>During the development phase of the formulation, whether different buffers, salts, stabilizers (e.g. lactose, gelatin, sorbitol, etc.) and other chemical factors are harmful to the safety, purity or potency of the vaccine should be determined.<br><br>Stability and expiration date<br>In the study of stability and validity period, three batches of finished products should be used to assess the stability of the product during the actual storage time, in order to establish the validity period of the product.<br><br>Since the validity of the vaccine is calculated from the beginning of the effectiveness trial of the finished product, consideration should also be given to the effects of three aspects on the validity of the vaccine, namely, the time of preservation of each component during production and before preparation, and the preservation time of the combined vaccine after the start of the pot trial.<br>The validity of the combined vaccine should begin (or qualify) from the date of the last effective effective trial of the first group in the combined vaccine.<br>The validity of the combined vaccine is determined by the shortest validity of the parts, i.e. the validity of each group should be taken into account.<br>The validity period of the finished product shall be established to ensure that the components of the product are stable and qualified for the duration of its total validity period (i.e., the storage period prior to the start of the validity period plus the validity period of the finished product).

（4） Effect of non active ingredients on combined vaccine<br>During the formulation development phase, whether different buffers, salts, stabilizers (such as lactose, gelatin, sorbitol, etc.) and other chemical factors have adverse interactions on the safety, purity or efficacy of vaccines should be determined.<br>Stability and validity<br>In the study of stability and validity period, three batches of finished products should be used to evaluate the stability of the products within the actual storage time, so as to establish the validity period of the products.<br>Since the validity period of the vaccine is calculated from the efficacy test of the finished product, the following three aspects should also be considered: the storage time of each component in the production process and before preparation, and the storage time of the combined vaccine before and after the beginning of the efficacy test.<br>The effective period of the combined vaccine shall start from the date of the last effective efficacy test for the first component in the combined vaccine.<br>The validity period of the combined vaccine should be determined according to the component with the shortest validity period, that is, the validity period of each component should be considered comprehensively.<br>The validity period of the finished product shall be determined to ensure that all components of the product are stable and qualified within its total validity period (i.e. the storage period before the expiration date plus the expiration date of the finished product).<br>