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GB 29923-2023 English PDF (GB29923-2023)
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
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 requir...
Get QUOTATION in 1-minute: Click GB 29923-2023
Historical versions: GB 29923-2023
Preview True-PDF (Reload/Scroll if blank)
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 requir...
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