Drugdu.com expert's response:

The requirements for storage conditions in stability studies of in vitro diagnostic reagents are as follows:

I. Specific Requirements for Storage Conditions

Temperature Conditions: The suitable storage temperature of the product must be described in detail in the product insert, for example, the common refrigerated condition is between 2°C and 8°C, or the frozen condition is below -18°C. Avoid using uncertain terms such as "refrigerated", "frozen", or "room temperature" to describe the storage temperature. If the stability of the product changes after the packaging is opened, it is necessary to specifically indicate the storage temperature conditions that the product or its components should follow after opening.

Other Environmental Factors: In addition to temperature conditions, it is also necessary to specify other factors that may affect the stability of the product, such as whether it needs to be stored away from light, as well as requirements for humidity, moisture protection, shock resistance, and other special storage conditions.

II. Requirements for Storage Conditions in Registration and Filing

Product Insert: When registering and filing, it is necessary to clearly indicate in the product insert the validity period of the product under the specified storage conditions, which is the period from the date of production to the date when the product can maintain its stable performance and be used normally. If the stability of the product is affected after it is unsealed, resulting in a different validity period from that in the unsealed state, the validity period of the product or its components after unsealing must be clearly stated to ensure that users can correctly understand and comply with it.

Comprehensiveness of Storage Conditions: When setting the storage conditions for reagents, enterprises should fully consider various possible extreme environments to ensure the stability of the reagents under various conditions. It is necessary to ensure that the research covers all declared extreme conditions, such as stability studies under long-term high or low temperatures, to comprehensively verify the stability of the reagents under extreme conditions.

III. Other Notes on Stability Studies

Study Duration: Stability studies of in vitro diagnostic reagents usually take several months. Enterprises should start the research as close to the production time as possible to ensure the timeliness of the data. At the same time, increase intermediate point detection to capture more dynamic changes, and consider the time period after the declared validity period to reserve enough space for stability assessment to avoid potential uncertainties.

Study Results: If the acceptance criteria are not clear, it will be difficult to accurately interpret the study results. Therefore, enterprises need to set specific and numerical acceptance criteria, clarify the data processing process, and use tables, charts, and other methods to clearly show the trend changes.

In summary, the storage conditions for stability studies of in vitro diagnostic reagents need to comprehensively consider various factors such as temperature, humidity, light exposure, moisture protection, shock resistance, etc., and be clearly stated in the product insert. At the same time, sufficient stability and validity period data are also required to support the safety and effectiveness of the product during registration and filing.