GB 17405-2025 English PDFUS$199.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. GB 17405-2025: National food safety standard - Good manufacturing practice for healthcare products Status: Valid GB 17405: Historical versions
Basic dataStandard ID: GB 17405-2025 (GB17405-2025)Description (Translated English): National food safety standard - Good manufacturing practice for healthcare products Sector / Industry: National Standard Classification of Chinese Standard: C53 Word Count Estimation: 10,186 Date of Issue: 2025-09-02 Issuing agency(ies): National Health Commission; State Administration for Market Regulation 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 National Standards of the People's Republic of China National Food Safety Standards Good Manufacturing Practices for Health Foods Published on 2025-09-02 Implemented on 2026-09-02 National Health Commission of the People's Republic of China State Administration for Market Regulation issued ForewordThis standard replaces GB 17405-1998 "Good Manufacturing Practices for Health Foods". Compared with GB 17405-1998, the main changes in this standard are as follows. ---The standard name has been changed to "National Food Safety Standard for Good Manufacturing Practices of Health Foods"; ---The standard structure has been modified; ---The range has been modified; ---Terminology and definitions have been revised; ---The site selection and plant environment requirements have been revised; ---The requirements for factory buildings and workshops have been revised; ---The requirements for facilities and equipment have been revised; ---Food safety management requirements have been added; ---The requirements for raw materials, excipients, and food-related products for health food products have been revised; ---The food safety control requirements for the production process have been revised; ---Verification requirements have been modified; ---The inspection requirements have been revised; --- Storage and transportation requirements have been revised; ---Added requirements for product recall and traceability management; ---Personnel training requirements have been revised; ---Requirements for record and file management have been modified; ---Appendix A, "Guidelines for the Division of Work Areas for Different Categories of Health Foods," has been added. National Food Safety Standards Good Manufacturing Practices for Health Foods 1.Scope This standard specifies the site selection and factory environment, factory buildings and workshops, facilities and equipment, food safety management, and other requirements for health food production enterprises. Food safety control, verification, inspection, storage and transportation, recall and traceability management of health food raw materials, excipients and food-related products, and the production process. Basic requirements and management guidelines for management, personnel training, record and document management, etc. This standard applies to the production of health food products. 2.Terms and Definitions The terms and definitions defined in GB 14881 and GB 16740 apply to this standard. 3.Site selection and factory environment It should comply with the relevant provisions of GB 14881. 4.Factory buildings and workshops 4.1 Basic Requirements It should comply with the relevant provisions of GB 14881. 4.2 Design and Layout 4.2.1 The cleanliness requirements of different dosage forms of health foods should be determined based on their product characteristics, production processes, production features, and the cleanliness requirements of the production process. The work area should be rationally divided, generally including a cleaning work area and a general work area. Health foods in food form should comply with the relevant food category regulations. Production area division requirements in production specifications. 4.2.2 Effective separation should be provided between work areas with different cleanliness levels, and separate personnel and material flow should be set up according to the cleanliness level. Access routes and other areas should be cleared to prevent cross-contamination. Examples of cleaning areas for non-food-type health food products are shown in Table A.1 of Appendix A. 4.2.3 Clean work areas should be equipped with independent air purification systems with filters, and maintain positive pressure with adjacent non-clean work areas to prevent... Prevent unpurified air from entering and causing cross-contamination. Cleanroom control requirements shall be implemented in accordance with Table 1. 4.2.4 If the production process includes pretreatment steps such as raw material crushing, extraction, and purification, the raw material pretreatment steps should be based on the product characteristics and production process. The process requires a reasonable design of the work area, effective separation from the finished product production area, and separate channels for personnel and material flow. 4.2.5 Work areas with high dust generation should have designs to prevent cross-contamination of dust, such as maintaining a relative negative pressure in the work area and using dust collection or removal equipment. Equipment installation, operation in confined spaces, etc. Table 1 Control Requirements for Cleaning Work Areas The project requires a minimum monitoring frequency for the testing methods. Suspended particles a ≥0.5μm ≤3,520,000 pieces/m³ GB/T 16292 ≥5μm ≤29000 pieces/m3 GB/T 16292 airborne bacteria b ≤500 CFU/m3 under dynamic conditions or static conditions ≤150 CFU/m3 GB/T 16293 Settling bacteria b Dynamically ≤100 CFU/4h (Φ90mm) Or ≤10 CFU/0.5h under static conditions (Φ 90mm) GB/T 16294 Air exchange rate c ≥ 10 times/h, measured by an anemometer or air volume meter. It should be based on product quality and safety control Control requirements and cleaning procedures for work areas Determine reasonable monitoring based on verification results. frequency control Cleaning work area and adjacent non-cleaning area Pressure differential in clean work area ≥10Pa was measured per shift using a differential pressure gauge. Temperature d 18℃~26℃ Measured per shift using temperature measuring instruments Relative humidity d ≤ 65% Measured per shift using humidity measuring instruments a applies to static conditions. b. Applicable to both dynamic and static conditions, one state detection method can be selected according to production conditions. c. The air change rate is applicable to clean work areas with a ceiling height of less than 4.0m. For clean work areas with a ceiling height of more than 4.0m, the air change rate can be adjusted appropriately, but it should be ensured that... Cleanliness control requirements for the cleaning work area. d. For production areas where special processes are located, temperature and relative humidity parameters should be established and specified based on the nature of the product and the operation. These parameters should not be inconsistent with the specified cleaning standards. The level of cleanliness can have adverse effects. 5.Facilities and Equipment 5.1 Basic Requirements It should comply with the relevant provisions of GB 14881. 5.2 Facilities 5.2.1 Facilities for changing clothes, changing shoes or shoe covers, hand washing, hand drying, and disinfection should be reasonably provided at the entrances of personnel passages in the cleaning work area. Necessary buffer and cleaning facilities should be provided. 5.2.2 For water used in contact with food with special requirements or for purified water, the corresponding preparation facilities should be available and meet the production process requirements. Sufficient to meet production needs. 5.2.3 Facilities for dehumidification, ventilation, and temperature control that meet the requirements should be provided according to the production process requirements. 5.3 Equipment 5.3.1 For production processes involving pretreatment steps such as raw material crushing, extraction, and purification, appropriate production equipment should be provided. Where solvents need to be recovered, appropriate solvent recovery equipment that meets relevant requirements should be provided. 5.3.2 The filling, packing, and sealing processes of the product should be completed using automated equipment. However, if the process is special and automated equipment cannot be used... The process should be verified to ensure that the product meets the quality and safety requirements and production process requirements of health food. 5.3.3 Oral liquids (excluding products whose main health food ingredients and excipients are propolis and honey), liquid milk products, beverages, and other liquid health foods. In addition, cleaning systems should be installed on the inner walls of equipment and pipelines that come into direct contact with the product during the raw material extraction or purification process. Major equipment pipelines should preferably be... Use a Clean In-Situ (CIP) system. If a CIP system is not available and other cleaning methods are used, cleaning validation should be performed to ensure... The equipment 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 should be established and effectively operated in accordance with the principles of hazard analysis and critical control points. 6.3 A supplier management system should be established, stipulating the procedures for supplier selection, review, and evaluation. Suppliers should be evaluated in accordance with the established procedures. The process flow and food safety control measures should be evaluated, and regular on-site reviews or monitoring of the production process should be conducted when necessary. 6.4 A system for the procurement, acceptance, storage, transportation, requisition, return, and shelf-life management of raw materials, excipients, and packaging materials for health food products should be established and implemented. Management system. 6.5 A management system for intermediate products, finished products, and non-conforming products should be established, mainly including the quality requirements, storage conditions, and shelf life of intermediate products. This includes restrictions, labeling, release of finished products, labeling, storage, and handling of non-conforming products. 6.6 A production batch management system should be established, clearly defining the rules for setting product batch numbers and production dates. 6.7 A stability testing system should be established for the raw material extracts, compound nutrients, and finished health food products produced by the enterprise. This system mainly includes testing... The timeframe and duration of the investigation, the items examined, the frequency and methods of testing, the stability testing methods, and the evaluation of results are all important aspects. 6.8 A clearing management system should be established, which mainly includes the clearing scope, clearing methods, clearing cycle, and clearing inspection. 6.9 A verification management system should be established, mainly including the confirmation of production-related plants, facilities, and equipment, as well as production processes and operating procedures. Verification, etc. 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 food products shall comply with the relevant technical requirements, food safety standards, and enterprise regulations for health food registration or filing. standard. 7.1.3 When purchasing raw materials, excipients, and packaging materials for health food products, the supplier's legal qualifications should be verified and relevant certification documents obtained; for those that cannot be verified... Raw materials and excipients for health foods that have obtained valid product qualification certificates should comply with relevant standards or technical requirements for health food registration or filing. It must be inspected and approved before it can be used. 7.1.4 Appropriate packaging materials should be selected based on the characteristics of the product. The packaging materials should effectively protect the product's functional or marker components. Stability ensures consistent product quality. 7.2 Requirements for animal and plant raw materials 7.2.1 The authenticity of raw materials should be verified in accordance with the relevant technical requirements for the registration or filing of health food products. 7.2.2 When purchasing animals, plants and their products that are required to undergo quarantine by law, valid quarantine certificates should be obtained. 7.2.3 When auditing and evaluating algae raw material suppliers, valid and qualified proof materials or reports on variety identification and genetic stability should be obtained. 7.2.4 For companies that produce their own algae raw materials, a production management system should be established in accordance with relevant requirements. 7.3 Requirements for microbial raw materials and non-purified fermentation product raw materials 7.3.1 Supply of raw materials such as filamentous fungi (excluding fruiting bodies), yeast, probiotic strains that can be used in health foods, and non-purified fermentation products. During the business review and evaluation, the business should request supporting materials or reports on strain or species identification, genetic stability, and safety. 7.3.2 Self-produced filamentous fungi (excluding fruiting bodies), yeast, probiotic strains suitable for health foods, non-purified fermentation products, etc. For materials, a production management system should be established in accordance with relevant requirements, and qualified raw materials should be used for microbial fermentation. ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of GB 17405-2025_English be delivered?Answer: Upon your order, we will start to translate GB 17405-2025_English as soon as possible, and keep you informed of the progress. The lead time is typically 1 ~ 3 working days. The lengthier the document the longer the lead time.Question 2: Can I share the purchased PDF of GB 17405-2025_English with my colleagues?Answer: Yes. 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