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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivery | Name of Chinese Standard | Status |
| GB 17405-2025 | English | 170 |
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National food safety standard - Good manufacturing practice for healthcare products
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| GB 17405-1998 | English | 110 |
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Good manufacture practice on health food
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Similar standards GB 17401 | GB 17403 | GB 17405-2025: National food safety standard - Good manufacturing practice for healthcare products
---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/GB17405-2025
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
GB17405-2025
National food safety standard - Good manufacturing
practices for health foods
Issued on: SEPTEMBER 02, 2025
Implemented on: SEPTEMBER 02, 2026
Issued by. National Health Commission of the People’s Republic of China;
State Administration for Market Regulation.
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... 6
6 Food safety management... 7
7 Raw materials, excipients, and food-related products for health foods... 8
8 Food safety control in the production process... 9
9 Validation... 13
10 Inspection... 13
11 Storage and transportation... 14
12 Product recall and traceability management... 14
13 Personnel training... 14
14 Record and document management... 14
Annex A Guidelines for the division of work areas for different categories of health
foods... 15
National food safety standard -
Good manufacturing practices for health foods
1 Scope
This Standard specifies the basic requirements and management guidelines for site
selection and factory environment, factory buildings and workshops, facilities and
equipment, food safety management, as well as raw materials, excipients and food-
related products for health foods, food safety control in the production process,
verification, inspection, storage and transportation, recall and traceability management,
personnel training, record and document management, etc. of health food production
enterprises.
This Standard applies to the production of health foods.
2 Terms and definitions
For the purpose of this Standard, the terms and definitions defined in GB 14881 and
GB 16740 apply.
3 Site selection and factory environment
It shall comply with the relevant provisions of GB 14881.
4 Factory buildings and workshops
4.1 Basic requirements
It shall comply with the relevant provisions of GB 14881.
4.2 Design and layout
4.2.1 The work area shall be reasonably divided according to the product characteristics,
production process, production characteristics, and cleanliness requirements in the
production process of different dosage forms of health foods. Generally, it includes a
clean work area and a general work area. Health foods in food form shall comply with
the production area division requirements in the corresponding food production
specifications.
4.2.2 Effective separation shall be provided between work areas with different
cleanliness levels, and separate personnel and material flow passages shall be set up
according to the cleanliness level to avoid cross-contamination. See Table A.1 in Annex
A for an example of the clean work area division for non-food form health foods.
4.2.3 Clean work areas shall be equipped with independent air purification systems with
filters and maintain positive pressure with adjacent non-clean work areas, to prevent
unpurified air from entering and causing cross-contamination. Clean work area control
requirements shall be implemented according to Table 1.
4.2.4 For production processes involving pre-processing steps such as raw material
crushing, extraction, and purification, the work area for the raw material pre-processing
steps shall be rationally designed according to product characteristics and production
process requirements, effectively separated from the finished product production area,
and separate personnel and material flow passages shall be set up.
4.2.5 Work areas with high dust generation shall have designs to prevent cross-
contamination of dust, such as maintaining a relative negative pressure in the work area,
using dust collection or removal facilities and equipment, and operating in a confined
space.
5 Facilities and equipment
5.1 Basic requirements
It shall comply with the relevant provisions of GB 14881.
5.2 Facilities
5.2.1 At the entrance of the personnel flow passage in the clean operation area, facilities
for changing clothes, changing shoes or shoe covers, hand washing, hand drying, and
disinfection shall be reasonably provided. Necessary buffer and cleaning facilities shall
be provided in the material flow passage.
5.2.2 If there are special requirements for water used in contact with food or requiring
the use of purified water, corresponding preparation facilities shall be available,
meeting the production process requirements and production needs.
5.2.3 Dehumidification, ventilation, and temperature control facilities that meet the
requirements shall be provided according to the production process requirements.
5.3 Equipment
5.3.1 For production processes involving pre-treatment steps such as raw material
crushing, extraction, and purification, production equipment suitable for raw material
pre-treatment shall be provided. If the solvent used in extraction needs to be recovered,
appropriate solvent recovery equipment that meets relevant requirements shall be
provided.
5.3.2 The filling, packing, and sealing processes of the product shall be completed using
automated equipment. For products where automation is truly impossible due to the
special nature of the process, process validation shall be conducted to ensure that the
product meets the quality and safety requirements and production process requirements
for health foods.
5.3.3 Liquid health foods such as oral liquids (excluding products whose main raw
materials and excipients are propolis and honey), liquid milk products, and beverages,
as well as equipment and pipelines in direct contact with the product during raw
material extraction or purification processes, shall be equipped with cleaning systems.
Clean-in-place (CIP) is recommended for major equipment and pipelines. If clean-in-
place (CIP) cannot be used and other cleaning methods are used, cleaning validation
shall be conducted to ensure that the equipment’s cleaning effect meets quality and
safety requirements.
6 Food safety management
6.1 It shall comply with the relevant provisions of GB 14881.
6.2 A food safety control system shall be established and effectively operated in
accordance with the principles of hazard analysis and critical control points.
6.3 A supplier management system shall be established, specifying the procedures for
supplier selection, review, and evaluation. The process flow and food safety control
measures adopted by suppliers shall be evaluated according to the evaluation
procedures. Regular on-site reviews or monitoring of the production process shall be
conducted when necessary.
6.4 A management system for the procurement, acceptance, storage, transportation,
requisition, return, and shelf-life of raw materials, excipients, and packaging materials
for health foods shall be established and implemented.
6.5 A management system for intermediate products, finished products, and non-
conforming products shall be established, mainly including quality requirements,
storage conditions and expiration dates, and labeling of intermediate products; release
of finished products; and labeling, storage, and handling of non-conforming products.
6.6 A production batch management system shall be established, clearly defining the
rules for setting product batch numbers and production dates.
6.7 A stability study system shall be established for the raw material extracts, compound
nutrients, and finished health food products produced by the enterprise, mainly
including the study time points and duration, study items, testing frequency and
methods, stability test methods, and result evaluation.
6.8 A site clearing management system should be established, which mainly includes
the site clearing scope, site clearing methods, site clearing cycle, and site clearing
inspection.
6.9 A verification management system shall be established, which mainly includes the
confirmation of production-related factory buildings, facilities and equipment, as well
as the verification of production processes and operating procedures.
7 Raw materials, excipients, and food-related products for
health foods
7.1 Basic requirements
7.1.1 It shall comply with the relevant provisions of GB 14881.
7.1.2 Raw materials, excipients, and packaging materials for health foods shall comply
with the relevant technical requirements for registration or filing of health foods, food
safety standards, and enterprise standards.
7.1.3 When purchasing raw materials, excipients, and packaging materials for health
foods, the supplier’s legal qualifications shall be verified and relevant certificates of
conformity shall be obtained. For raw materials and excipients for health foods for
which valid certificates of conformity cannot be obtained, they shall be inspected
according to the corresponding standards or the relevant technical requirements for
registration or filing of health foods, and may only be used after passing the inspection.
7.1.4 Appropriate packaging materials shall be selected according to the product
characteristics. Packaging materials shall effectively protect the stability of the
product’s functional components or marker components, ensuring stable product quality.
7.2 Requirements for animal and plant raw materials
7.2.1 The authenticity of raw materials shall be verified according to the relevant
technical requirements for registration or filing of health foods.
7.2.2 When purchasing animals, plants, and their products that are subject to quarantine
according to law, valid quarantine certificates shall be obtained.
7.2.3 When auditing and evaluating algae raw material suppliers, valid and qualified
certificates or reports on variety identification and genetic stability shall be obtained.
7.2.4 For those producing algae raw materials themselves, a production management
system shall be established in accordance with relevant requirements.
7.3 Requirements for microbial raw materials and non-purified fermentation
products
7.3.1 When auditing and evaluating suppliers of raw materials such as filamentous fungi
(excluding fruit bodies), yeast, probiotic strains that can be used in health foods, and
non-purified fermentation products, certificates or reports on strain or species
identification, genetic stability, and safety shall be obtained.
7.3.2 For those producing raw materials such as filamentous fungi (excluding fruit
bodies), yeast, probiotic strains that can be used in health foods, and non-purified
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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