GB 17405-1998Good manufacture practice for health food (English PDF)
保健食品良好生产规范
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Issued by
Ministry of Health of the People's Republic of China
Level / Type
National · Mandatory
Issue date
June 8, 1998
Implementation date
January 1, 1999
Scope
GB 17405-1998 is the English-translated version of 保健食品良好生产规范.
GB 17405-1998 is the Chinese mandatory good manufacturing practice (GMP) for health food, setting the basic technical requirements for enterprises that produce foods with specific health functions.
It covers personnel (qualified technical staff making up at least 5% of the workforce, training, annual health checks), plant design and facilities with a general production area and class 100 000 clean areas, with Table 1 fixing dust particle, viable microorganism and air change limits for class 10 000 and class 100 000 rooms.
Further clauses regulate raw material acceptance and documentation (strain identification for fermentation and probiotic materials, irradiation and hormone records), the production process from operating procedures, charging and batching to sterilization, filling, packaging and marking, and the storage and transport of finished products.
It also requires an independent quality management system with control of raw materials, critical control points of processing, batch testing and retained samples of finished products and 2 to 3 years of record keeping, and hygiene management according to GB 14881.
The standard draws on the Chinese pharmaceutical GMP, the WHO GMP and HACCP principles; it was issued on 8 June 1998 by the Ministry of Health and has been in force since 1 January 1999.
Classification: ICS 67.040, CCS C53. The document runs to 8 pages, delivered complete in English translation.
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Document preview — GB 17405-1998
National Standard of the People's Republic of China
- ICS
- 67.040
- Classification
- C53
Issued by: Ministry of Health of the People's Republic of China
Contents
- Foreword
- 1 Scope
- 2 Referenced standards
- 3 Definitions
- 4 Personnel
- 5 Design and facilities
- 6 Raw materials
- 7 Production process
- 8 Storage and transport of the finished products
- 9 Quality management
- 10 Hygiene management
3 Definitions
4 Personnel
5 Design and facilities
6 Raw materials
7 Production process
8 Storage and transport of the finished products
9 Quality management
10 Hygiene management
Foreword
In the course of drafting, this standard partly adopted the content on clean factory buildings of the Good Manufacturing Practice for Pharmaceutical Products of China (1992 revised edition). In format and content it drew on the Good Manufacturing Practices for Pharmaceutical Products of the World Health Organization (WHO). For general building design and hygiene requirements it drew on GB 14881-1994 General hygienic standard of food enterprises.
Because this practice belongs to the domain of food production, its requirements for personnel, buildings and facilities and retention of documents are lower than those of the good manufacturing practice for pharmaceutical products, but higher than those of the General hygienic standard of food factories.
In drawing up this standard, full reference was made to the principles of Hazard Analysis Critical Control Point (HACCP), and specific requirements are set out for a number of critical steps.
This standard was proposed by the Ministry of Health of the People's Republic of China.
This standard was drafted under the responsibility of the Institute of Food Safety Control and Inspection, Ministry of Health, with the participation of the Fujian Provincial Institute of Food Hygiene Supervision and Inspection, the Guangdong Provincial Institute of Food Hygiene Supervision and Inspection, the Liaoning Provincial Institute of Food Hygiene Supervision and Inspection, the Shenyang Municipal Health and Anti-epidemic Station, the Tianjin Municipal Centre for Disease Prevention and Control, and Fujian Fulong Biological Products Co., Ltd.
Main drafters of this standard: Bao Dayue, Li Tairan, Lin Shengqing, Zhang Yonghui, Shi Gensheng, Xiao Dongsheng, Liu Changhui, Liu Hongde, Zheng Pengran, Sheng Wei.
The Ministry of Health has entrusted the Institute of Food Safety Control and Inspection, Ministry of Health, with the interpretation of this standard.
Approved by the Ministry of Health of the People's Republic of China on 1998-05-05; implemented from 1999-01-01.
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 8 pages — is available in the English PDF.
Referenced standards
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