GB 23790-2023 National food safety standard-Good manufacturing practice for formulae for infants and young children
1 Scope
This standard specifies the basic requirements and management guidelines for sites, facilities and personnel for raw material purchasing, processing, packaging, storage and transportation during the manufacturing of formulae for infants and young children.
This standard is applicable to the manufacturing of formulae for infants and young children with milk and/or soybeans and their processed products as the main protein sources.
2 Terms and definitions
For the purposes of this standard, the terms and definitions given in GB 14881, GB 10765, GB 10766 and GB 10767 apply.
2.1 wet-mix process
manufacturing process by which all constituents of the powered formulae for infants and young children are processed in a liquid phase to obtain the final product, generally including procedures such as batching, heat-treatment, concentration and drying, packaging (filling)
2.2 dry-mix process
manufacturing process by which all constituents of the powered formulae for infants and young children are processed in a solid phase and blended physically to obtain the final product, generally including procedures such as batching, mixing (including premixing) and packaging (filling)
2.3 combined process
complete manufacturing process by which some of the constituents of the powered formulae for infants and young children are processed in a liquid phase and then dried, other ingredients are added in a dry form by dry process, and then all ingredients are packaged (filled) to obtain the final product
2.4 liquid process
manufacturing process by which all constituents of the formulae for infants and young children are processed in a liquid phase to obtain the final liquid product, generally including procedures such as batching, homogenization, sterilization, filling and sealing (also including the sterilization process after filling and sealing)
3 Site selection and plant environment
3.1 The relevant requirements of GB 14881 shall be met.
3.2 The site shall be set far away from livestock and poultry farms, and animals shall not be raised at the plant area.
4 Plant buildings and workshops
4.1 Basic requirements
The relevant requirements of GB 14881 shall be met.
4.2 Design and layout
4.2.1 The plant buildings and workshops shall be reasonably designed, planned and constructed to adapt to the facilities and equipment, so as to prevent hazards from microbial contamination and microbial breeding, especially the contamination of Salmonella and Cronobacter (Enterobacter sakazakii). The following aspects shall be considered during the design:
a) Wet and dry areas shall be effectively separated; contamination caused by the mobility of personnel, equipment, facilities and materials shall be effectively controlled to prevent microorganisms, such as Salmonella and Cronobacter (Enterobacter sakazakii), that are liable to cause harm to infants and young children from entering the clean working area.
b) The clean working area shall be free of condensed water.
c) The wet cleaning procedures shall be designed reasonably, and improper wet cleaning shall be avoided in dry areas.
d) Gaps between pipes, cables and holes passing through the floors, ceilings and walls of buildings shall be well enclosed or sealed.
4.2.2 According to the product characteristics, production process and the requirements for cleanliness in the production process in combination with the actual situation of the plant building and workshop, reasonable zoning shall be carried out. Generally, the plant building and workshop shall be divided into general working area, quasi-clean working area and clean working area.
a) The general working area includes milk collection room, raw material warehouse, packaging material warehouse, outer packaging workshop and finished product warehouse as well as sterilization area of post-sterilized liquid products after filling and sealing.
b) The quasi-clean working area includes raw material pretreatment workshop, raw material inner packaging cleaning or packaging material disinfection or tunnel sterilization area, wet processing area for powdered products (such as weighing, batching and concentration), weighing, batching, heat treatment and sterilization or disinfection area for liquid products, filling area for post-sterilized liquid products.
c) The clean working area includes the workshops where procedures (such as weighing, batching and mixing) are conducted in contact with the air environment without subsequent sterilization or disinfection, the filling area of liquid aseptic filling products, and auxiliary area with special cleaning requirements (such as temporary storage rooms for clean and disinfected inner packaging), storage areas for bare semi-finished products, filling and inner packaging workshops.
4.2.3 Effective separation shall be set between working areas with different cleanliness levels. An independent air purification system with filtration device shall be installed in the clean working area, and it shall maintain a positive pressure to prevent unpurified air from entering the clean working area and causing cross-contamination.
4.2.4 Reasonable and effective control measures shall be taken when entering and leaving the clean working area to avoid or reduce microbial contamination and other contamination. Personnel, raw materials, packaging materials, wastes and equipment, etc. entering and leaving the clean working area shall be provided with measures to prevent cross-contamination, such as setting up personnel locker rooms to replace work clothes, work shoes or shoe covers, setting up special logistics channels, and ensuring the sealing protection of waste. For airborne materials transported through pipelines to the clean working area, an appropriate air filtration system shall be designed and installed for carrier airflow.
4.2.5 The dynamic control requirements of the clean working area for production of powdered formulae for infants and young children shall meet the requirements of Table 1, and such requirements of the clean working area for production of liquid formulae for infants and young children shall meet the requirements of Table 2, and shall be tested regularly. The number of sedimental viable particles in the air of quasi-clean working area shall be less than or equal to 50CFU/dish (determined according to GB/T 16294 for 5min), and shall be monitored and recorded.
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Foreword i
1 Scope
2 Terms and definitions
3 Site selection and plant environment
4 Plant buildings and workshops
5 Facilities and equipment
6 Hygiene management
7 Food raw materials, food additives and food-related products
8 Food safety control in production process
9 Inspection
10 Storage and transportation of food
11 Product recall management
12 Training
13 Management system and personnel
14 Record and document management
Annex A Guide for environmental monitoring of Salmonella, Cronobacter (Enterobacter sakazakii) and other Enterobacteriaceae in clean working area for powered formulae for infants and young children
