婴幼儿配方乳粉和特殊医学用途配方食品工艺验证的实施探讨

Discussion on process validation of infant formula milk powder and foods for special medical purpose

中文关键词:  婴幼儿配方乳粉  特殊医学用途配方食品  工艺规程  工艺验证  产品生命周期

英文关键词:infant formula  foods for special medical purpose  process procedure  process validation  product lifecycle

中文摘要:

      我国食品安全法规定婴幼儿配方乳粉的产品配方和特殊医学用途配方食品需要进行注册管理, 而在注册相关配套文件中要求这2类产品在申请注册时需要提供工艺验证相关材料, 有效的工艺验证是产品质量的重要保证。由于工艺验证在药品中的应用较为广泛, 本文通过对药品生产工艺验证指南的学习, 结合食品工厂实际与实例, 研究以基于产品生命周期的验证方法实施婴幼儿配方乳粉和特殊医学用途配方食品的工艺验证策略, 并对婴幼儿配方乳粉和特殊医学用途配方食品的工艺规程、工艺验证方案和工艺验证报告的内容组成提出了建议, 为这2类食品的工艺验证实施提供理论参考。

英文摘要:

      China’s Food Safety Law stipulates that the product formula of infant formula milk powder and formula food for special medical purposes need to be registered and administered. The registration related supporting documents require these 2 types of products to provide process verification related materials when applying for registration, effective process verification is an important guarantee for product quality. Due to the wide application of process validation in drugs, this paper studied the process validation strategy of infant formula milk powder and formula food for special medical purposes based on product life cycle verification method through the study of pharmaceutical production process validation guidelines, combined with the actual situation and examples of food factories. In addition, suggestions were put forward on the process specification, process validation scheme and process validation report of infant formula milk powder and formula food for special medical purposes, in order to provide theoretical reference for the implementation of process validation of these 2 kinds of food.