★Q&A Infant Formula Milk Powder Product Formula Registration (Certification Materials for R&D capability II)★
Q: Regarding 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..
....
