LOGO

Q&A Infant Formula Milk Powder Product Formula Registration (Quality and Technology IV)

 
Q
1. What does the nutrient conformance analysis include in the commercial manufacturing process validation report?
A
This includes analyzing at least one batch of trial production samples to see if they meet the requirements of standards and label values.
 
Q
2. What does the process stability analysis include in the process validation report for commercial production?
A
Stability analysis should include the following: 
 
(1) Stability analysis between different batches, such as testing and variation coefficient analysis of unstable indicators in three batches of trial production samples, providing stability criteria and analyzing and illustrating process stability. 
 
(2) Stability analysis of process parameters of main production processes, such as multi-batch determination of parameters of main processes to judge whether the production process parameters are within the required range, so as to determine the stability of equipment process.
pexels-pixabay-451853
Q
3. What does the raw material feeding information include in the commercial production process validation report?
A
Uniformity analysis refers to the analysis of the uniformity of samples in the same batch. For example, at least three or more samples of trial production products are taken in different periods of time, and the indicators that are not easy to be mixed in the samples are tested and the coefficient of variation is analyzed. 
 
Sampling methods and criteria for uniformity determination are provided, and sample uniformity is analyzed and explained. Sample uniformity analysis indicators include at least essential macro-nutrients, vitamins, minerals, optional ingredients and other ingredients that are not easily mixed. In each type of indicators, ingredients with small dosage and difficult to mix (such as active bacteria, lactoferrin) should be selected. 
 
Uniformity verification of dry mix samples using base powder (or wet-produced semi-finished products) should, in principle, include the corresponding indicators of all dry mix components. For dry mixing with more nutrients, representative nutrients can be selected to verify the uniformity according to the actual situation and provide reasonable explanations.
 
Q
4. What does a commercial manufacturing process validation report include?
A
This include three batches of trial production of raw material and auxiliary materials feeding information, analysis of sample uniformity, process stability and nutrient conformance, and process verification conclusions.
Q
5. Is it necessary to produce 1 ton of product according to the formula scale when commissioning the sample?
A
When trial-producing samples, it is not necessary to make a 1000kg product feed according to the formula and dosage table, and the feed can be enlarged or reduced in proportion according to the formula and dosage table.
 

Need help or have a question?

Send mail