GB/T 32689-2016 in English
VALIDGood manufacturing practice for amino acid fermentation
- Issued on:2016-06-14
- Implemented on:2017-01-01
- File Format:PDF
- Delivery:Via email within 1~3 business days
$204.00
《GB/T 32689-2016发酵法氨基酸良好生产规范》由TC64（全国食品工业标准化技术委员会）归口，主管部门为国家标准化管理委员会。
Introduction
GB/T32689—2016 Standard Overview
GB/T32689—2016 Good Manufacturing Practice for Amino Acids by Fermentation is a national standard of the People's Republic of China, which aims to guide enterprises that produce amino acids by fermentation to establish and implement good production management practices. The standard was officially implemented on January 1, 2017, covering all aspects from plant facilities to quality management.
Background of Standard Formulation and Analysis of Technological Evolution
With the rapid development of biotechnology, the technology of producing amino acids by fermentation has become increasingly mature, and market demand has continued to grow. However, the hygiene, quality and safety issues in the production process have gradually become the focus of the industry. The formulation of this standard is based on relevant domestic and foreign laws and regulations and practical experience, combined with the characteristics of the fermentation process, and proposes systematic management requirements and technical specifications.
Comparison table of standard frameworks
| Dimensions | GB/T32689—2016 | GMP comparison | Industry characteristics |
|---|---|---|---|
| Plant facilities | Clear site selection, layout and design requirements | Emphasis on clean area division | The fermentation process has high requirements for a sterile environment |
| Equipment management | Specify equipment materials, design and maintenance requirements | Focus on equipment cleaning and sterilization | Fermentation tanks and piping systems are core equipment |
| Personnel management | Require professional knowledge and training before taking up the post | Emphasis on hygiene and personal protection | Microbiological operations have high requirements for personnel |
Implementation recommendations
Small and medium-sized enterprises: It is recommended to prioritize the optimization of plant layout and equipment cleaning and disinfection processes, while strengthening employee hygiene training.
Large enterprises: It is recommended to introduce automated control systems (such as DCS) to monitor the fermentation process and establish a complete strain management system.
Newly-commissioned enterprises: Production areas and facilities should be designed in strict accordance with standard requirements. It is recommended to entrust a professional team to carry out clean room construction and certification.
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