This guidance includes the explanation of batch size, test parameter, types of studies, study designs, etc. The test projects will be mainly divided into physical, chemical and biological experiments. Active ingredient concentration testing is also mandatory.
Frequently asked Q&A
Q1: What should we do if we have already conducted the stability testing before the release of the Guidance?
A1:
Implementation Progress of the stability Testing | Shall follow this guidance or not |
1. The company has started the stability testing before this notice. The testing is still ongoing. And the company hasn’t applied for the health food permit registration. | Yes |
2. The company has finished the stability testing before this notice. But it hasn’t applied for the health food permit registration. | Yes |
3. The stability testing is carried out after the release of this notice. | Yes |
4. The company has obtained the health food license. And it applies for a new function in a new case. | Yes |
… |
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Q2: Shall the samples used for other tests (safety evaluation test, functional evaluation test, hygiene test, general nutritional component analysis, etc) be the same batch used for stability testing?
A2: If the samples used in these tests are not from the same batch, the company shall provide relevant production and product management records (eg: material order sheet, material requisition form, functional component test report, etc) as evidence to ensure the product quality of that batch is compliant as well.
This guidance shall be implemented from the release date.
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