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National food safety standard - Good manufacturing practice for formula food for special medical use
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National Food Safety Standard GMP of Formula Food for Medical Use
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GB 29923-2023: PDF in English 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 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.
Annex A
Computer system application guide for special medical purpose formula
food manufacturing enterprises
A.1 The computer systems of enterprises producing formula foods for special medical
purposes shall be able to meet the food safety regulatory requirements of the "Food
Safety Law of the People's Republic of China" and its related laws, regulations and
standards. A complete information chain shall be formed that helps trace, track, and
locate food safety issues in every link from raw materials entering the factory to product
leaving the factory. It shall be able to submit or remotely submit relevant data as
required by regulatory authorities. The computer system shall meet (but not be limited
to) the requirements of A.2~A.11.
A.2 The system shall include data collection and record keeping functions related to
food safety in various aspects such as raw material procurement and acceptance, raw
material storage and use, monitoring of key control links in production and processing,
product exit-factory inspection, product storage and transportation, and sales.
A.3 The system shall be able to assess and provide early warning on the food safety
risks of the company's relevant raw materials, processing techniques and products.
A.4 The system and supporting database shall establish and use a complete authority
management mechanism. Ensure the mandatory use of staff accounts/passwords. In
terms of security architecture, ensure that there are no loopholes in the system and
database that allow unauthorized access.
A.5 On the basis of the authority management mechanism, the system shall implement
a complete security policy. Set corresponding policy groups for different staff to ensure
that users in specific roles only have corresponding permissions. All data contacted and
generated by the system shall be stored in the corresponding database. They shall not
be stored in file form. Make sure all data access is subject to system and database
permission management controls.
A.6 Adopt special security policies for confidential information to ensure that only the
owner of the information has the right to read, write and delete operations. If
confidential information really needs to be stored and transmitted outside the security
control scope of systems and databases, ensure that:
a) Encrypt and store confidential information to prevent unauthorized persons from
reading the information;
b) A check code is generated before the confidential information is transmitted. The
check code and the information (after encryption) are transmitted separately. The
check code is used at the receiving end to confirm that the information has not
been tampered with.
A.7 If the system needs to collect data generated by automated detection instruments,
the system shall provide a safe and reliable data interface. Ensure accuracy and high
availability of interface parts. Ensure that the data generated by the instrument can be
collected by the system in a timely and accurate manner.
A.8 Complete and detailed system and database log management functions shall be
implemented, including:
a) System logs record every user login to the system and database (user, time, login
computer address, etc.);
b) The operation log records every modification of data (including modification user,
modification time, modified content, original content, etc.);
c) System logs and operation logs shall have storage strategies. Within the set time
limit, no user (excluding system administrators) can delete or modify it to ensure
traceability within a certain time limit.
A.9 Develop a system usage and management system, which must include at least the
following:
a) A real-time recording system for original data, intermediate data, generated data
and processing procedures in the work process to ensure that the entire work
process can be reproduced;
b) A detailed backup management system ensures that the entire system and
corresponding data can be fully restored as soon as possible after a disaster occurs;
c) The computer room shall be equipped with a smart UPS uninterruptible power
supply and connected to the working system. Ensure that the UPS takes over the
power supply in the event of an external power outage and notifies the working
system to perform data saving and log operations (the UPS shall be able to
provide power to ensure the system's emergency save operation time);
d) There is a sound data access management system, and confidential data is strictly
prohibited from being stored on shared devices. Data sharing within departments
shall also adopt a rights management system to achieve authorized access;
e) A supporting system maintenance system, including regular storage and system
testing, ensures long-term stable operation of the system;
f) The security management system requires regularly changing the passwords of
users in various parts of the system, limiting the login locations of some users,
and promptly deleting accounts that are no longer needed;
......
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.
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