GB 29923-2023National food safety standard - Good manufacturing practice for formula food for special medical use (English PDF)

Foreword

This document was issued on 6 September 2023 by the State Administration for Market Regulation; Standardization Administration of the PRC and takes effect on 6 September 2024.

It is a GB standard without the /T suffix: compliance is mandatory in China.

1 Scope

GB 29923-2023 is the good manufacturing practice rule for plants making formula food for special medical purposes, the products that serve as the sole or principal source of nutrition for patients who cannot eat an ordinary diet. Building on GB 14881, it covers site selection and factory environment, buildings and workshops, facilities and equipment, health management, incoming raw materials, food additives and food-related products, food safety control during production, verification, inspection, storage and transport, product recall, training, the management system and its personnel, and records and documents. One annex sets out how computer systems are to be used in these plants and another gives commercial aseptic practice for liquid formulas. The controls are tighter than for ordinary food because the consumer is a patient. A product short of one nutrient, carrying an allergen from a neighbouring line, or not commercially sterile in a liquid pack reaches someone with no alternative diet and often no working defence against infection, so harm follows within days instead of being buffered by a varied diet. Verification exists so that a plant can show a process does what it is claimed to do, and the record rules so that it can prove afterwards which control operated on a given batch. Manufacturers, their quality units, auditors and inspectors work to it, and it is mandatory.

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 monitoring plan shall be developed for the production process with

reference to Annex A in GB 14881-2013, combined with the requirements of the

production process and relevant product standards such as GB 29922 and GB 25596.

Implement effective monitoring. The total number of bacteria and Enterobacteriaceae

are used as indicator bacteria. When monitoring results indicate deviations, appropriate

8.5.3 Key process parameters such as heat treatment time and temperature shall be

recorded.

8.6 Intermediate product storage

8.6.1 Semi-finished products or containers shall be identified or recorded. Information

such as name, production time, etc. can be obtained through identification or records.

8.6.2 According to the storage characteristics of the product, the storage temperature

and time of the liquid intermediate shall be controlled to prevent the growth of

microorganisms.

8.6.3 If exposed semi-finished products need to be temporarily stored in the production

of solid products, they shall be stored in a clean working area. If they need to be placed

outside the cleaning work area, measures such as sealed packaging shall be taken to

prevent contamination. There shall be identification information such as name,

production time, storage period and storage conditions.

8.7 Commercial aseptic processing of liquid products

The operating instructions in Anex C shall be used.

8.8 Control requirements for specific processing techniques of solid products

8.8.1 Drying of powdered products

During the production of powdered products, the transportation pipelines and

equipment from heat treatment to drying shall be kept closed. Clean and disinfect

material contact surfaces regularly.

8.8.2 Cooling

8.8.2.1 If the dried exposed semi-finished product needs to be cooled, it shall be done

in a clean working area.

8.8.2.2 In the wet and dry-wet composite production of powdered products, monitoring

measures shall be established for the air inlet temperature of the fluidized bed and the

temperature of the semi-finished product at the outlet of the fluidized bed.

8.8.3 Dry mixing of powdery product dry process and dry-wet composite process

8.8.3.1 Bare powder processes that are in contact with ambient air (such as premixing

and packaging, batching, and feeding) shall be carried out in a clean operating area.

8.8.3.2 The temperature and relative humidity of the cleaning operation area shall be

monitored in accordance with the requirements in Table 1.

8.8.3.3 Key process parameters related to mixing uniformity (such as mixing time, etc.)

shall be verified. The homogeneity of the mix shall be confirmed.

8.8.3.4 Strict hygiene control requirements shall be established for raw materials,

packaging materials and personnel. Raw materials shall enter the work area through

necessary cleaning procedures and material channels. The procedures for removing the

outer packaging, or cleaning and disinfecting the outer packaging shall be followed.

8.8.4 Inner packaging

8.8.4.1 The inner packaging process shall be carried out in the clean operating area.

8.8.4.2 Raw materials and packaging materials and personnel entering the inner

packaging room shall comply with the provisions of 8.8.3.4 and 6.4.

8.8.4.3 For powdery products, effective foreign matter control measures shall be

adopted, such as setting up screens, strong magnets, and metal detectors; and

effectiveness verification shall be implemented.

9 Verification

9.1 The production process needs to be verified to ensure the reproducibility of the

entire process and the controllability of product safety. Verification shall include plant,

facility and equipment installation verification, operation verification, performance

verification and product verification.

9.2 Verification items shall be proposed based on the verification objects, verification

plans shall be formulated, and implementation shall be organized.

9.3 The production process and key facilities and equipment of the product shall be

verified according to the verification plan. When the main factors affecting product

safety and quality (including nutritional ingredients), such as processes, safety and

quality control methods, main raw materials and auxiliary materials, main production

equipment, etc., change, and after a certain production cycle, re-verification shall be

carried out.

9.4 After the verification work is completed, a verification report shall be formed, which

shall be reviewed and approved by the person in charge of the verification work. The

data and analysis content during the verification process shall be archived and saved in

the form of files. Verification documents shall include verification plans, verification

reports, evaluations and suggestions, approvers, etc.

10 Inspection

It shall comply with the relevant provisions of GB 14881.