GB 17405-2025National food safety standard - Good manufacturing practice for healthcare products (English PDF)

Foreword

This document was issued on 2 September 2025 by the State Administration for Market Regulation; Standardization Administration of the PRC and takes effect on 2 September 2026.

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

1 Scope

GB 17405-2025 is the Chinese national food safety standard setting good manufacturing practice for health foods. Health foods sit between food and medicine in Chinese regulation - registered or filed with claimed functions, taken daily over long periods, and often by the elderly - so the manufacturing controls are pitched closer to pharmaceutical practice than to ordinary food processing, with validated processes and segregated work areas by product category. The standard sets the requirements for site selection and the factory environment, the buildings and workshops, the facilities and equipment, food safety management, the raw materials, excipients and food-related products used, food safety control in production, validation, inspection, storage and transport, product recall and traceability, personnel training, and records and document management, with an annex giving guidance on dividing the work areas for the different categories of health food. It takes effect on 2 September 2026.

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

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