GB17405-1998
Good manufacture practice for health food
保健食品良好生产规范
GB 17405-1998 is a current mandatory Chinese national standard for Good manufacture practice for health food. It appears in the Food compliance cluster with a product safety focus and has an implementation date of Jan 1, 1999.
Applicability depends on product scope, certification route, competent authority notices and transition rules. Requst for the translation or verify source before using this record in a compliance decision.
Compliance overview
Scope and applicability
GB 17405-1998 establishes the Good Manufacturing Practice (GMP) for the Chinese health food industry. It applies to all enterprises producing foods with specific health functions, covering personnel, facility design, raw materials, manufacturing processes, and quality management. This standard is mandatory for all health food manufacturers operating in China. It sets requirements that are stricter than general food hygiene regulations but slightly less stringent than pharmaceutical GMPs, heavily incorporating HACCP principles.
Technical requirements
The standard specifies comprehensive technical and hygienic requirements across the entire production lifecycle. Key areas include personnel qualifications, where technical staff must hold relevant degrees and health certificates. For facility design, it mandates rational layout to prevent cross-contamination, requiring specific cleanroom levels (e.g., 100,000-level) for products like tablets, capsules, and oral liquids. Regarding raw material management, the standard requires strict verification of supplier test reports, strain identifications for microbial ingredients, and controlled storage conditions. Manufacturers must establish rigorous acceptance, storage, and tracking systems for all inputs. For the production process, it dictates the formulation of detailed standard operating procedures (SOPs). It enforces dual-checking for formulations, prohibits manual filling for most products, and requires strict environmental controls. Cross-contamination must be prevented through separated material flows and dedicated equipment cleaning. Finally, quality management requires an independent department to monitor critical control points, retain samples, and conduct stability tests.
Testing methods
GB 17405-1998 outlines evaluation procedures focusing on process validation and environmental monitoring rather than specific product testing methods. Key assessments include cleanroom environmental monitoring (dust particle counting, viable microorganism counting, and air exchange rate verification), process validation for sterilization equipment, and water quality testing to ensure compliance with GB 5749. It also mandates batch-by-batch inspection of sensory, hygienic, and functional components.
FAQs
What types of products and facilities are regulated under GB 17405-1998?
It applies to all enterprises engaged in the production of health foods with specific health functions, covering requirements for personnel, facility design, raw materials, manufacturing processes, and quality management.
How does GB 17405-1998 differ from general food safety standards?
It incorporates principles from the Good Manufacturing Practice for Drugs and HACCP. Its requirements for personnel, facilities, and documentation are stricter than general food hygiene standards but less stringent than pharmaceutical GMPs.
Does the standard specify cleanroom requirements for health food production?
Yes, it mandates specific cleanroom classes (e.g., 100,000-level) for manufacturing tablets, capsules, and non-terminally sterilized oral liquids, complete with requirements for air filtration and environmental monitoring.
The summary above provides a high-level overview of GB 17405-1998. To ensure complete compliance for your products entering the Chinese market, a precise and professional translation of the full technical specifications is essential. Purchase our high-quality English translation of GB 17405-1998 today to access all detailed parameters, tables, and testing procedures.
Applicability hints
- Type
- Health and hygiene
- CCS
- C53
- ICS
- 67.040
- Competent department
- National Health Commission
- Technical committee
- National Health Commission