高风险区必须配备以下何种员工设施？When an operation includes a high-risk area, which of the following staff facilities must be in place?
a) 访客使用的鞋套 Shoe covers for visitors
b) 更衣次序的清晰说明 Clear instructions for the order of changing clothes
c) 区域入口的鞋子清洗装置 A boot wash at the entrance to the area
d) 高风险区域员工专用的的洗手间 Segregated toilets for use by high-risk staff
以下何种产品类别的生产场所通常会被定义为高风险区域？Which of the following groups of products would usually be expected to be produced in a factory with a high risk area?
a) 已清洗的用于制作沙拉的蔬菜 Washed prepared salad vegetables
b) 含有水果的冰淇淋 Ice Cream with real fruit pieces
c) 饼干/曲奇 Biscuits/cookies
d) 冷藏售卖的含乳烘培甜点 Baked dairy dessert sold chilled
工厂内的实验室若用于检测致病菌，则必须：A site laboratory analysing pathogenic bacteria must have:
a) 获得ISO 17025认可 An accreditation against ISO 17025
b) 有证据证明参与了对比试验 Evidence that they take part in a ring test program
c) 与其他场所隔离且有相关程序以避免为产品带来风险 A fully segregated laboratory and specific procedures to prevent risk to products
d) 要求人员进入实验室前须佩戴口罩等防护措施 Specific requirements to wear mouth protection before entering the laboratory
以下何种清单会被用于过敏原管理以减少产品之间的过敏原污染风险？Which of the following shall be used for allergen management to minimize the risk of allergen contamination of products?
a) 欧盟定义的过敏原清单 the EU list of defined Allergens as per the glossary
b) 厂家所在国家/地区的过敏原清单 the Allergen list in the country of manufacture
c) 适用于产品销售区域的过敏原清单 the allergen list appropriate to the place of sale
d) 同时适用于厂家所在国家/地区以及销售国家/地区的过敏原清单 The allergen list appropriate to both the country of manufacture and sale.
以下何种方式为最受认可的用于验证含过敏原产品及不含有过敏原产品生产间隙之间的清洁效果？Which of the following would provide the most acceptable validation of the cleaning method between an
allergen containing and allergen free production?
a) 对清洁完毕的生产线进行目测 Visual inspection of the production line after cleaning
b) 清洁完毕的标准ATP生物荧光检测 The use of a standard ATP Bio luminescence test after cleaning
c) 针对特定过敏原的定量ELISA检测 The use of a quantitative ELISA test methods for a specific allergen(s)
d) 清洁完毕的生产线涂抹棒微生物检测 Microbiological swab tests of the production line following cleaning
