EXD-SP-2018 NSF膳食补充剂和功能食品项目cGMP审核条款.doc

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EXD-SP-2018 NSF膳食补充剂和功能食品项目cGMP审核条款

NSF GMP 指导文件21CFR § 11/111 NSF/ANSI 173 第 8 章节

Prepared by NSF International 789 N. Dixboro Rd. Ann Arbor, MI 48105

Subpart B 111.10-111.14 Personnel 人员

Question 1 CFR 111.10

Procedures have been established that define work requirements for personnel to prevent microbial contamination from illness。

建立人员健康控制程序，以防由于人员患病而导致的微生物污染。

A written procedure shall exist and be current stating that personnel with medical conditions such as open lesions or infected wounds will be removed from the manufacturing process so as to prevent product adulteration during manufacturing or storage. The procedure shall state that such health conditions will be reported to supervision.