If the packaging specification of in vitro diagnostic reagent changes, the difference of packaging specification before and after the change shall be described in detail. All relevant potential risks shall be identified according to the specific differences, and these risk factors shall be analyzed and verified. Some examples are as below:
if there are differences in the reaction form (such as poison detection products) and reaction film size (such as PCR amplification and hybridization products) of the packaging specification before and after the change, the analysis performance evaluation dossiers of the changed packaging specification shall be submitted.Before and after the change, the amount of packaging specifications and containers will change significantly, which will lead to the increase of evaporation loss and other risks. Therefore, it is necessary to consider whether the shelf life, stability and calibration frequency of the product will change.
