On 26 January 2017, CFDA released two supplementary documents for infant formula milk powder formula registration relating to labeling and stability research for public comments. Opinions and advises shall be given before 20 February 2017. Generally, the stability research during the formula registration includes influencing factors test, accelerated test, long-term test, etc. Here CIRS will focus on the Stability Guideline, to help you better understand the relevant important stability research requirements.
1. Influencing factors test
Enterprise can take 1 batch of samples to conduct the influencing factors test. Generally, it includes high-temperature test, high humidity test and Illumination test.
|
Tests |
General condition |
|
High-temperature test |
Ø Temperature: 60℃ Ø Duration: 10 days Ø Sampling time: the 5th day and the 10th day If the samples changed significantly, the temperature can change to 40℃. |
|
High humidity test |
Ø Temperature: 25℃ Ø Humidity: RH90％±5％ Ø Duration: 10 days Ø Sampling time: the 5th day and the 10th day If the hygroscopic weight is more than 5%, the condition can change to 25℃, RH75％±5％. |
|
Illumination test |
Ø Illumination: 4500Lx±500Lx Ø Duration: 10 days Ø Sampling time: the 5th day and the 10th day |
PS. If the conditions are differing from above, the relevant scientific basis shall be provided.
2. Accelerated test
Enterprise shall take 3 batches of samples to conduct the accelerated test.
|
Items |
Requirements |
|
Test duration |
At least 1/4 of the production shelf life, and at least 3 months. |
|
Sample time |
Take the 6 months test duration as a sample: The sampling time shall be at 0 month, 1 month, 2 months, 3 months and 6 months. Among them, the test data of 0 month samples can be replaced with the quality test results of the same batch. |
|
Test condition |
Temperature: ≥40℃ Humidity: ≥RH75％ |
PS. If the conditions are differing from above, the relevant scientific basis shall be provided.
3. Long-term test
Enterprise shall take 3 batches of samples to conduct the long-term test.
|
Items |
Requirements |
|
Test duration |
At least as long as the expected shelf life. |
|
Sample time |
I. At the end of every 3 months in the first year, at the end of every 6 months in the second year II. Take product with shelf life of 24 months as a sample: The sampling time shall be at 0, 3, 6, 9, 12, 18, 24 months. Among them, the test data of 0 month samples can be replaced with the quality test results of the same batch. |
PS. 1. If the conditions are differing from above, the relevant scientific basis shall be provided.
2. The long-term test can be started together with the accelerated test. The registration applicant can submit the registration application when the accelerated test is finished, and promise to continue to complete the long-term test.
If you have any needs or questions, please contact us at service@cirs-group.com
Reference: http://www.sfda.gov.cn/WS01/CL0782/169260.html.
