QRegarding the "Guidelines for Product Stability Research of Infant Formula Milk Powder (Trial)" (hereinafter referred to as the "Guidelines"), what are the specific requirements for the samples used for stability research?A
The samples used for stability studies should be produced under commercial production conditions. In principle, the samples used for stability research are in the same batch as the samples used for production process validation. If different batches are used, the reasons should be explained.
QDuring the product shelf-life stability study, if the self-built method is used without the national standard detection method, what are the requirements for the self-built method verification material?A
If the self-built testing method is adopted, it can refer to "Conformity Assessment - Confirmation and Verification of Chemical Analysis Methods" (GB/T 27417-2017) for verification and submit verification materials.
QDoes a product shelf-life stability study have to be done on its own? Can a third-party inspection agency be entrusted to test the stability research test project? What qualifications does a third-party inspection agency need to have?A
The applicant should have the research and development capabilities of the formula, and the product shelf-life stability research needs to be completed by itself. The test items in the stability study can be tested by themselves and/or by entrusting a third-party testing agency according to the actual situation, and the reasons for entrusting the third-party testing agency shall be explained. Third-party testing agencies need to have the qualifications for testing items and are responsible for the testing results.
QHow to understand the "Guidelines" that "for some active strains that are not suitable for accelerated test conditions, historical long-term data of similar formulations at the same water activity can be used for analysis"?A
If the active bacteria added to the formula are the same as before after adjustment according to the new national standard, and the water activity is not much different, the historical long-term data of the registered formula of the same applicant before the adjustment can be used for analysis.
QDo applicants need to submit product shelf-life stability research materials if they apply for change registration? Do stability studies need to be submitted for both accelerated and long-term testing?A
If the registered product formula is adjusted according to the new national standard, whether it is registered as a change or a new formula, it is necessary to provide shelf-life stability research materials. Applicants can submit accelerated test research materials or long-term test materials.
