Current Status of Domestic Research on the Stability of In Vitro Diagnostic Reagents
At present, most companies have begun to attach importance to stability research content in the research and development process, but some companies still have many problems in the stability research materials submitted during the product registration process. like:
① The company focuses its research on the stability of expiration date and accelerated stability, ignoring the research on the stability of product opening, transportation, and the stability of quality control products and calibrators contained in reagents;
②Enterprises have different product stability inspection items. Some companies only inspect whether the final chemical and biological properties of reagents meet the requirements, while some companies increase the inspection of the physical properties of the reagents, such as appearance, loading, and migration speed;
③ In the study on the stability of the validity period, some companies are studying the products that are stored under the specified storage conditions to the end of the validity period, and some companies are studying the products that are stored under the specified storage conditions to 1, 2 months or even half a year after the validity period;
④ In the research of the product transportation stability project, the simulated transportation conditions of the same product in the research projects of different manufacturing companies are very different;
⑤ In the research on the stability of products containing calibrators and quality control products, some companies only inspected the "accuracy" items of calibrators and quality control products, while ignoring the inspection of items such as "uniformity";
⑥ When formulating the product expiration date, most companies rely on the product expiration stability research data, and a small number of companies rely on the product acceleration stability research data;
⑦ Only one batch of product stability research work has been carried out, and three batches of product stability experiments have not been carried out in accordance with the requirements of regulations;
⑧ Due to the short time limit for retaining samples of actual production samples during registration and application, some companies use samples from the preliminary laboratory research and development process instead of actual production samples to investigate product stability;
⑨ The description of the results of the stability study experiment is too general. For example, using sentences such as "CV value less than 10%" and "in compliance with product technical requirements", etc., specific test data should be provided based on the actual test results;
⑩ Only the research data at the end of the stability investigation period is provided, and the stability research data at different time periods during the stability investigation process is not provided;
⑪ Different companies have inconsistent requirements for the validity period of the same type of products, such as the validity period of the glycosylated hemoglobin detection products ranging from 6 to 36 months.
