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GB 29923-2023: National food safety standard - Good manufacturing practice for formula food for special medical use
GB 29923-2023
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
National Food Safety Standard -- Good Manufacturing
Practice for Formulas for Special Medical Purposes
ISSUED ON: SEPTEMBER 06, 2023
IMPLEMENTED ON: SEPTEMBER 06, 2024
Issued by: State Administration for Market Regulation;
Standardization Administration of the People's Republic of China.
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Terms and definitions ... 4
3 Site selection and factory environment ... 4
4 Factory buildings and workshops ... 4
5 Facilities and equipment ... 7
6 Health management ... 8
7 Food raw materials, food additives and food-related products ... 10
8 Food safety control during production ... 11
9 Verification ... 14
10 Inspection ... 14
11 Food storage and transportation ... 15
12 Product recall management ... 15
13 Training ... 15
14 Management system and personnel ... 15
15 Records and document management ... 15
Annex A Computer system application guide for special medical purpose formula food
manufacturing enterprises ... 16
Annex B Environmental monitoring guidelines for Salmonella, Cronobacter
(Enterobacter sakazakii) and Enterobacteriaceae in cleaning work areas of powdered
special medical purpose formulas ... 19
Annex C Guidelines for commercial aseptic practice of liquid formulas for special
medical purposes ... 23
National Food Safety Standard -- Good Manufacturing
Practice for Formulas for Special Medical Purposes
1 Scope
This Standard specifies the basic requirements and management guidelines for sites,
facilities, and personnel in the production process of formula foods for special medical
purposes such as raw material procurement, processing, packaging, storage, and
transportation.
This Standard applies to the production of formula foods for special medical purposes.
2 Terms and definitions
For the purposes of this document, the terms and definitions defined in GB 14881, GB
25596 and GB 29922 apply.
3 Site selection and factory environment
They shall comply with the relevant provisions of GB 14881.
4 Factory buildings and workshops
4.1 Basic requirements
They shall comply with the relevant provisions of GB 14881.
4.2 Design and layout
4.2.1 Factories and workshops shall 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, contamination by Cronobacter spp.
(Enterobacter sakazakii) shall also be prevented. The following shall be considered in
the design:
a) Wet and dry areas shall be effectively separated. Cross-contamination caused by
the flow of personnel, equipment, facilities and materials shall be effectively
controlled;
b) Properly plan the stacking of materials. Avoid places that are not conducive to
cleaning due to improper stacking;
c) Enclose or seal various pipes, cables and penetration gaps that pass through
building floors, ceilings and walls;
d) Wet cleaning processes shall be designed properly. Improper wet cleaning shall
be prevented in dry areas;
e) The cleaning work area shall prevent the generation of condensation water.
4.2.2 Operations in dry processing areas without subsequent sterilization (or
disinfection) operations, such as operations from drying (or post-drying) processes to
filling and sealing packaging, shall be conducted in clean operating areas.
4.2.3 Products with subsequent sterilization (or disinfection) processes are in contact
with ambient air before sterilization (or disinfection) (such as weighing, batching, etc.),
and wet processing areas for powdered products (such as weighing, batching,
concentration, etc.) can be performed in a quasi-clean work area. However, its safety
shall be verified in accordance with the requirements of 9.2 and 9.4 to ensure the quality
and safety of the product.
4.2.4 Effective separation shall be set up between working areas with different
cleanliness levels. An independent air purification system with filtration device shall be
installed in the cleaning work area. Maintain positive pressure. Prevent unpurified air
from entering the clean work area and causing cross-contamination.
4.2.5 The cleaning work area shall be kept dry. Water supply facilities and systems shall
avoid passing through the upper space of the main production operation surface. If it
cannot be avoided, protective measures shall be taken to prevent contamination.
4.2.6 There shall be reasonable and effective control measures in and out of the cleaning
work area to avoid or reduce microbial and other contamination. People, raw materials,
packaging materials, waste, equipment, etc. who enter and leave the cleaning operation
area shall take measures to prevent cross-contamination, such as setting up locker
rooms for personnel to change work clothes, work shoes or shoe covers; materials
entering the cleaning operation area must be removed from the outer packaging or the
outer packaging shall be cleaned and disinfected; there are dedicated logistics channels
and waste channels or waste sealing protection. If waste sealing protection is used,
ensure that the sealing protection is intact. For materials transported through pipelines
using airflow as a carrier to enter the cleaning operation area, an appropriate air
filtration system shall be designed and installed for the carrier airflow.
4.2.7 The environment of the cleaning work area shall comply with the requirements in
Table 1. For the production of infant formula for special medical purposes, the clean
working area environment shall also comply with the requirements of GB 23790. The
number of sedimentation bacteria in the air in the quasi-clean operation area shall be
5 Facilities and equipment
5.1 Facilities
5.1.1 Basic requirements
They shall comply with the relevant provisions of GB 14881.
5.1.2 Drainage facilities
5.1.2.1 Drainage facilities shall be avoided in clean work areas where solid products
are produced. If installation is indeed necessary, appropriate measures shall be taken to
keep the drainage facilities in a dry state during production.
5.1.2.2 Drainage systems shall have slopes. Keep them clear and easy to clean. There
shall be no dead corners for cleaning at the joints between the sides and bottom of the
drainage ditch, or corresponding measures shall be taken to prevent the accumulation
of water. Drainage facilities in the work area shall prevent sewer backflow and turbid
gas escape. Hygienic clean floor drains shall be used when necessary.
5.1.2.3 There shall be no water supply lines for process water in or below the drainage
system.
5.1.3 Personal hygiene facilities
5.1.3.1 Changing rooms (including changing shoes or wearing shoe covers), hand
washing and drying facilities, and disinfection facilities shall be set up near the entrance
of the production site or production workshop.
5.1.3.2 Personnel shall take necessary cleaning measures before entering the cleaning
work area. A dedicated locker room shall be set up at the personnel entrance. Set up
hand disinfection facilities before entering the cleaning work area. Hand washing
facilities are not required.
5.1.4 Ventilation facilities
5.1.4.1 Air conditioning facilities shall be installed in the cleaning work area. The
power of air conditioning facilities shall meet the control requirements of workshop
cleanliness, temperature, and humidity. In areas where odor, dust, steam or other
harmful gases are generated, there shall be corresponding elimination, collection or
control devices.
5.1.4.2 The outdoor air inlet shall be more than 2 m away from the ground or roof, and
away from pollution sources and exhaust outlets. and equipped with air filtration device.
5.1.4.3 Compressed air or other gases used for food production and cleaning food
contact surfaces and equipment shall be de-oiled, water removed, clean filtered and
sterilized before use.
5.1.5 Warehousing facilities
Refrigerated (frozen) warehouses shall be equipped with monitoring facilities such as
thermometers, temperature measuring devices or automatic temperature recorders to
monitor and record the temperature.
5.2 Equipment
5.2.1 Basic requirements
They shall comply with the relevant provisions of GB 14881.
5.2.2 Other requirements
5.2.2.1 Storage, transportation and processing systems (including gravity, pneumatic,
closed and automatic systems, etc.) shall be easy to maintain in good sanitary condition.
5.2.2.2 Equipment spare parts shall be stored in dedicated areas. Keep spare parts
storage areas clean and dry.
5.2.2.3 Equipment shall be verified or confirmed to ensure that various performances
meet process requirements. In particular, equipment used for dry mixing shall be able
to ensure that the product is mixed evenly. Measuring instruments and key instruments
used in production shall be calibrated regularly. Production equipment shall have
obvious operating state signs and shall be repaired, maintained and verified regularly.
Equipment installation, repair, and maintenance operations shall not affect product
quality.
5.2.2.4 Key equipment such as sterilization and mixing shall have operating state
monitoring and fault alarm functions or effective monitoring measures.
5.2.2.5 When a computer system and its network technology are used for critical control
point monitoring data collection and record management, the relevant functions of the
computer system and its network technology may refer to the provisions of Annex A.
6 Health management
6.1 Basic requirements
They shall comply with the relevant provisions of GB 14881.
6.2 Factory and facility hygiene management
6.2.1 Regular inspections shall be carried out on the ceiling, walls, floors, equipment
and facility connections and other locations in the cleaning work area. Discover and
6.4.2 Personnel shall undergo procedures such as changing clothes and disinfecting
hands in the cleaning area before entering the cleaning area to ensure the hygiene of the
hands of relevant personnel.
6.5 Waste disposal
Containers containing waste, processing by-products, and inedible or hazardous
materials shall be specially labeled, properly constructed, and watertight. Containers
shall be closed when necessary to prevent contamination of food.
7 Food raw materials, food additives and food-related products
7.1 Basic requirements
7.1.1 They shall comply with the relevant provisions of GB 14881.
7.1.2 A supplier management system shall be established to stipulate the procedures for
supplier selection, review, and evaluation.
7.1.3 The raw materials, processes and food safety control measures used by suppliers
shall be evaluated. Regular on-site reviews or monitoring of the production process
shall be carried out when necessary.
7.1.4 The acceptance criteria for relevant raw materials and packaging materials shall
be determined based on the characteristics of the product formula. Ensure product
quality and safety needs are met.
7.2 Storage requirements
7.2.1 During storage, it shall be stored in zones according to the characteristics of
different raw materials and packaging materials. Establish a logo to indicate relevant
information and quality state.
7.2.2 Food additives shall be stored in a special warehouse or area. Use a special register
(or warehouse management software) to record the name, purchase time, purchase
volume and usage of food additives, etc. Pay attention to validity period.
7.2.3 The raw materials of products with special requirements for allergenic substances
shall be separated or stored in special areas from the raw materials containing the
specific allergenic substances. They shall be clearly marked to avoid access errors and
contamination.
7.2.4 For raw materials such as vitamins whose quality is prone to change during
storage, as well as raw materials and packaging materials whose quality may change
due to storage conditions and other reasons, the quality shall be confirmed before use.
Carry out sampling testing when necessary to ensure compliance with specified
requirements.
8 Food safety control during production
8.1 Basic requirements
8.1.1 They shall comply with the relevant provisions of GB 14881.
8.1.2 The relevant principles of hazard analysis and critical control points shall be
followed. Establish and effectively operate a strict food safety control system.
8.1.3 Before each production, check whether the equipment is in normal condition.
8.1.4 When weighing and batching, ensure that the type and quantity of raw materials
meet the requirements of the product formula. Weighing shall be accurate and have a
review process. The types of raw materials shall be reviewed again when feeding. If a
computer information system is used to realize automated control, manual review does
not need to be used, but the computer information system shall have error-proofing
design and regular verification.
8.2 Control of microbial contamination
8.2.1 Necessary measures shall be taken to prevent microbial contamination during the
entire process from the entry of raw materials and packaging materials to the delivery
of finished products.
8.2.2 Real-time temperature and humidity monitoring measures shall be established to
control and record the temperature and humidity in the cleaning operation area. Verify
regularly.
8.2.3 Methods to kill microorganisms or inhibit the growth and reproduction of
microorganisms shall be adopted based on the characteristics of the product, such as
heat treatment, freezing or refrigerated storage, etc. Establish temperature and time
control measures and corrective measures. Implement effective monitoring and regular
verification.
8.2.4 For processing links that strictly control temperature and time, real-time
monitoring measures shall be established. Keep monitoring records.
8.2.5 Microbial monitoring
8.2.5.1 A microbial mo...