Q&A Infant Formula Milk Powder Product Formula Registration (Quality and Technology III)_News & Articles

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

Ellie WangGlobal Foodmate20 Jan 2022

How to provide quality and safety standards for raw materials?

The variety of food raw materials and food additives used should be consistent with the formula submitted by the applicant. Compound ingredients, compound food additives and food additive preparations should be should be listed in the list of ingredients, and all levels of raw and auxiliary materials should provide quality and safety standards.

The raw and auxiliary materials that implement national standards or announcements by the health administration department (excluding QB, NY and other industry standards) shall provide the current effective standard number or announcement number.

What are the control parameters and control measures of text description of production process specifications, related production equipment and critical control point (CCP)?

The text description of production process refers to the text description corresponding to the flow chart of production process, including the process description and process parameters marked in the flow chart, as well as the batching point, batching sequence and batching methods of raw materials and auxiliary materials.

The relevant production equipment should be provided in the form of a list of main production equipment, including the name and model of the equipment. Wet process equipment includes: pasteurization equipment (using raw milk), batching equipment, homogenizing equipment, sterilization equipment, concentration equipment, spray drying equipment, packaging equipment; Dry process equipment includes: tunnel sterilization equipment, metering batching equipment, premix equipment, mixing equipment, product packaging equipment; The dry-wet composite process equipment includes the wet process production and dry process production equipment.

Critical control point control parameters and control measures can be determined based on the actual needs of the enterprise, including the scientific and reasonable description of the critical control point setting, and the detailed description of control parameters and control measures.

What are the main production processes?

The main production processes of wet process generally include milk clarify and pasteurization (using raw milk), ingredients, homogenization, sterilization, concentration, spray drying and cooling, product packaging;

Dry process generally includes material preparation feeding, metering batching, premix, dry mixing, product packaging;

The dry-wet composite process includes all the main production processes of the wet process and the dry process.

What materials are included in the process specification?

I. Where the formula of a registered product is adjusted according to the new national standard and the registration certificate indicates that the process has changed, the production process description shall include the following materials:

1. The registration certificate shall state the reason and rationality of the process change.

2. Explain the similarities and differences of production processes (including production processes, process parameters, critical control points, main production equipment, operation area division, raw and auxiliary materials batching, etc.) between the same series and different formulations, and list the main differences in the form.

3. Complete production process flow chart and its text. Production process flow chart should be clear in words, indicating the main production process, critical control points and their process parameters, operation area division. The production process text includes the production process text description, related production equipment (name, model), control parameters and control measures of critical control point.

II. The product formula and production process description materials applied for registration for the first time include the following materials:

1. Explain the similarities and differences of production processes (including production processes, process parameters, critical control points, main production equipment, operation area division, raw and auxiliary materials addition, etc.) between the same series and different formulations, and list the main differences.

2. Complete production process flow chart and its text. Production process flow chart should be clear in words, indicating the main production process, critical control points and their process parameters, operation area 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 point.

Do formulations made with base powder require commercial process validation using different batches of base powder?

Formulations manufactured using base powder shall be commercially validated using three batches of base powder.

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