What contents are included in documents related to strain traceability and contamination prevention and control of miscellaneous bacteria?

Documents related to strain traceability and contamination prevention and control of miscellaneous bacteria include the source description of strain raw materials, strain identification reports, and prevention and control measures for possible product contamination due to the use of strains (such as quality specifications and test reports of active bacteria raw materials, active bacterial raw material management, process control related to final product production, related items testing in final products).

What documents does the production process description include?

The production process description includes the following documents:

(1) The registration certificate stating the reason and rationality of process change.

(2) A description of the similarities and differences between the production processes (including production procedures, process parameters, critical control points, main production equipment, work areas division, raw and auxiliary materials addition links) between different recipes of the same series, and the main differences are marked in a list.

(3) Complete production process flow diagram and its text. The production process flow diagram shall be clearly written, indicating the main production procedures, critical control points and process parameters, as well as work areas division. The production process text includes the text description of production process, related production equipment (name, model), control parameters and control measures of critical control points.

What contents are included in the main production procedures?

The main production procedures of wet process generally include cleaning milk and pasteurizing (using raw milk), preparing ingredients, homogenizing, sterilizing, concentrating, spray drying and cooling, packing products; dry process generally includes preparing and feeding ingredients, metering ingredients, pre-mixing, dry mixing, product packaging; the dry-wet composite process includes all the main production procedures of the above-mentioned wet process and dry process.

What contents are included in the text description of production process, related production equipment (name, model), control parameters and control measures of key control points?

The text description of production process refers to the text description corresponding to the production process flow diagram, including the description of each procedure, process parameters, and the adding link, sequence and method of each raw and auxiliary material marked in the flow diagram.

Related production equipment is provided in a list of main production equipment, including equipment name and model. Wet process equipment includes: pasteurization equipment (using raw milk), preparing ingredients equipment, homogenization equipment, sterilization equipment, concentration equipment, spray drying equipment, packaging equipment; dry process equipment includes: tunnel sterilization equipment, metering and preparing ingredients equipment, pre-mixing equipment, mixing equipment, product packaging equipment; dry-wet composite process equipment includes the above-mentioned wet production and dry production equipment.

Control parameters and control measures of critical control points can be determined according to the actual needs of enterprises, including the scientific and reasonable explanation of the critical control point settings, and the detailed description of control parameters and control measures.

What does it means that “the unchanged information does not need to be submitted repeatedly”?

After the registered product formula is adjusted according to the new national standards, the unchanged information does not need to be submitted repeatedly. For example, if the implementation standards for raw materials and food additive are not changed, they do not need to be submitted repeatedly (except for food additive preparations); if the registration certificate states that the process are not changed, the production process description does not need to be submitted repeatedly; if the control plan for pollutants, microorganisms, mycotoxins and other hazardous substances that may be contained are not changed, it does not need to be submitted repeatedly.

More information on Q&A on product formula registration of infant and young children formula milk powder, please click Q&A on Product Formula Registration of IF.

If you want to know more about New Standards and infant formula registration requirements, please contact us!

Hongtao Fei

Tel: 010-51301566

email: feiht@antion.net