GB 29923-2023 English PDF (GB29923-2023)

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GB 29923-2023: National food safety standard - Good manufacturing practice for formula food for special medical use
GB 29923-2023. National Food Safety Standard Good Manufacturing Practice for Formulas for Special Medical Purposes
National Standards of People's Republic of China
National food safety standards
Good Manufacturing Practice for Formulas for Special Medical Purposes
Published on 2023-09-06
Implemented on 2024-09-06
National Health Commission of the People's Republic of China
Released by the State Administration for Market Regulation
Preface
This standard replaces GB 29923-2013 "National Food Safety Standard Good Manufacturing Practice for Formula Foods for Special Medical Purposes".
Compared with GB 29923-2013, the main changes in this standard are as follows.
---Deleted relevant terms and definitions in Terms and Definitions;
---Changed the workshop where liquid products are in contact with ambient air (such as weighing, batching, etc.), and the wet processing area of powdered products (such as weighing
Minimum cleaning requirements for dosing, concentration and drying);
---Changed the name of Enterobacter sakazakii;
---Unify and change the air cleanliness requirements for solid product and liquid product cleaning work areas and quasi-clean areas;
---Deleted the requirement for workshop lighting coefficient;
---Added urease inactivation requirements for raw materials containing soy protein;
---Added prevention requirements for allergenic substances;
---Added water requirements for the production and processing of solid products;
---Deleted the statement "Salmonella and Enterobacter sakazakii are specified as pathogenic bacteria in this standard" in Appendix B.
National food safety standards
Good Manufacturing Practice for Formulas for Special Medical Purposes
1 Scope
This standard specifies the locations, locations, processing, packaging, storage and transportation of raw materials during the production of formula foods for special medical purposes.
Basic requirements and management guidelines for facilities and personnel.
This standard applies to the production of formula foods for special medical purposes.
2 Terms and definitions
The terms and definitions defined in GB 14881, GB 25596 and GB 29922 apply to this standard.
3 Site selection and factory environment
Should comply with the relevant provisions of GB 14881.
4 Factory buildings and workshops
4.1 Basic requirements
Should comply with the relevant provisions of GB 14881.
4.2 Design and layout
4.2.1 Factory buildings and workshops should be reasonably designed, planned and constructed to be compatible with facilities and equipment to prevent microbial contamination and growth.
Especially contamination by pathogenic bacteria such as Salmonella. For infant formulas for special medical purposes, Cronol rods should also be prevented
Contamination by bacteria (Enterobacter sakazakii). The following should be considered in the design.
a) Wet areas and dry areas should be effectively separated, and cross-contamination caused by the flow of personnel, equipment, facilities, and materials should be effectively controlled;
b) Reasonably plan the stacking of materials to avoid improper stacking that creates places that are not conducive to cleaning;
c) Enclose or seal various pipes, cables and penetration gaps that pass through the floor, ceiling and wall of the building;
d) The wet cleaning process should be reasonably designed, and improper wet cleaning should be prevented in dry areas;
e) The cleaning work area should prevent the generation of condensation water.
4.2.2 Operations in dry processing areas without subsequent sterilization (or sterilization) operations, such as from drying (or post-drying) processes to filling and sealing packaging
Operation should be carried out in a clean working area.
4.2.3 Products with subsequent sterilization (or sterilization) processes are in contact with ambient air before sterilization (or sterilization) (such as weighing, ingredients, etc.), powdered
Wet processing areas of products (such as weighing, batching, concentration, etc.) can be carried out in quasi-clean operating areas, but their safety should be in accordance with 9.2 and 9.4
Verification is required to ensure product quality and safety.
4.2.4 Effective separation should be set up between working areas with different cleanliness levels. The cleaning work area should be equipped with an independent filtering device
Air purification system and maintain positive pressure to prevent unpurified air from entering the clean work area and causing cross-contamination.
4.2.5 The cleaning work area should be kept dry. Water supply facilities and systems should avoid passing through the upper space of the main production operation surface. If it cannot be avoided,