Microsoft Word 冯波二校 2359

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1 8 6 Vol. 8 No Journal of Food Safety and Quality Jun., 2017 ISO22000 C 冯波 * *, 陈强 (, ) 摘要 : 目的 C ISO22000, C 方法 ISO22000, (hazard analysis critical control point, HACCP), C,, 5, 结果 2 (critical control point, CCP), (operational prerequisite program, OPRP) HACCP, C, ISO22000 结论, HACCP,,,, 关键词 : C ; ISO22000; ; ; Application of ISO22000 in the production of vitamin C tablets for health care products FENG Bo *, CHEN Qiang * (By-Health Co., Ltd., Zhuhai , China) ABSTRACT: Objective To apply ISO22000 food safety management system in the production of vitamin C tablets for health care products, and to prevent and control the potential hazards in the production, processing, storage and transportation of vitamin C tablets for health care products. Methods According to the ISO22000 food safety management system standard and hazard analysis critical control point (HACCP) quality management principles, the potential hazards in the process of vitamin C tablets for health care products were analyzed, and the corresponding preventive measures and monitoring methods were put forward. From 5 aspects of human, machines, materials, laws and links, the corresponding control measures were formulated. Results Two critical control points (CCP) for raw material acceptance and metal detection were determined, and critical limits and corrective actions were also determined. At the same time, through the formulation of operational prerequisite program (OPRP) and HACCP work plan, the model of food safety management system of vitamin C tablets for health care products was constructed, which conformed to the ISO22000 system. Conclusion The development of operational prerequisite program, and * 通讯作者 :,, @qq.com,, [email protected] *Corresponding author: FENG Bo, Assistant Engineer, By-Health Co., Ltd., No.19 Xinghan Road, Sanzao Science and Technology Industrial Park Jinwan District, Zhuhai , China @qq.com. CHEN Qiang, Executive pharmacist, By-Health Co., Ltd., No.19 Xinghan Road, Sanzao Science and Technology Industrial Park Jinwan District, Zhuhai , China. [email protected]

2 the combination of the OPRP and critical control points in the HACCP dynamically and complementarily reduce the food safety hazard factors to a minimum, protect the safety of health care products preferably, reduce the enterprise management costs and improve the economic returns. KEY WORDS: vitamin C tablets for health care products; ISO22000; process control; quality control; hazard analysis 1 引言 2005 ISO22000 (codex alimentarius commission, CAC) (hazard analysis and critical control point, HACCP) [1], HACCP, [2],, ISO22000,, ISO22000 C, C,,,, ;, 24 h ; C, [3,4] ISO22000 C, [5], ISO22000,,,, [6], C, 2 产品描述用途及工艺流程 2.1 产品描述 C C, 2.2 产品用途及消费人群 C C 2.3 工艺流程 2.4 研究方法 HACCP 7 C [7],,, C, 3 危害分析 3.1 工艺危害分析原辅料检验 C C,,,, [8] 称量备料,,, 2,,,, [9,10] 湿法制粒,,,,,, [11] 干燥,,,,, [12] 总混,,, [13],,

3 6, : ISO22000 C 压片,,, [14] 金属检测,,, 包衣,, 2,,,,, [15,16] 包装入库,, [17] 3.2 关键控制点的确定 HACCP, C, ( 1) C : [18,19] 3.3 制定 HACCP 计划表 C,,,,,,, ( 2),, [20] Table 1 表 1 保健品维生素 C 片生产过程危害分析 Hazard analysis of vitamin C tablets for health care products,, CCP1, SOP,, SOP, SOP 75%,, SOP 75% SOP, 75% :,, SOP, SOP SOP, SOP CCP2

4 Table 2 表 2 保健品维生素 C 片 HACCP 计划表 HACCP schedule of vitamin C tablets for health care products ( Pb ) 0.5 mg/kg ( As ) 0.3 mg/kg (CCP1) 1000 cfu/g MPN/100 g 40 cfu/g,, 25 cfu/g (CCP2) ΦO0.3 mm ΦO0.35 mm ΦO0.2 mm,,,, Table 3 表 3 保健品维生素 C 片的 OPRP 控制及验证措施 OPRP control and validation of vitamin C tablets for health care products,, 2, : ,, 3.4, 3.5, 3.6, , 4.3,, 5, , 5.3, 1. GB ,, 1 1.( ), 1., 2., 4.,,, 5., 6., 7., 1.,, 2.,,,, 2.,

5 6, : ISO22000 C 2363 续表 ,, , 1. 2., 3. 5., ,, 2. 3.,, 8 8.1, ,, 2.,,, 4 操作性前提方案的制定 (operational prerequisite program, OPRP)() [21],, (sanitation standard operating procedure, SSOP) 8 C OPRP 3 C 5, C OPRP,, [22,23] 5 结论, OPRP HACCP,HACCP OPRP OPRP,, OPRP CCP, CCP [24,25] C ISO22000, [26],,,,,,,, (),, ISO22000, ( CCP ),, [27,28] 参考文献 [1],,. HACCP [J]., 2010, 13(11): Wang R, Li L, Liu C. Application of HACCP in processing of healthcare vegetable beverages [J].Bever Ind, 2010, 13(11): [2],,,. [J]., 2013, (2): Dong F, Chen BJ, Wang Y, et al. Research on the significance and countermeasures of risk communication of agricultural product quality safety [J]. Agric Prod Qual Saf, 2013, (2): [3],. - [J]., 2014, 28(3): Liu YS, Chen J. Formation mechanism of food supply chain security risk: Based on behavioral economics [J]. China Bus Mark, 2014, 28(3): [4]. [J]., 2012,

6 (11): Lai FL. Experience of the Japanese food supply chain management model [J]. Sci Dev, 2012, (11): [5],,,. [J]., 2015, 3: Huang MX, Zhao WH, Bai WD, et al. Research advance of Listeria monocytogenes in meat and meat products [J]. Meat Ind, 2015, 3: [6]. [D]. :, Tian YN. Application of quality risk management in the production of oral solid dosage forms [D]. Kaifeng: Henan University, [7],,,. [J]., 2012, 10(11): Fu Q, Wu ZA, Xie JD, et al. Application of quality risk management in sterile API production [J]. Doctor Pharm, 2012, 10(11): [8]. [J]., 2015, 54(13): Feng JL. Path selection of China's food safety management based on supply chain collaborative management [J]. Hubei Agric Sci, 2015, 54(13): [9],,,. [J]., 2014, 5(3): Ping H, Ma HZ, Wang JH, et al. Advances in risk assessment of agricultural product quality and safety [J]. J Food Saf Qual, 2014, 5(3): [10]. HACCP [J]., 2014, (27): Yue Y. Study on quality control of food production process based on HACCP [J]. Manag Technol SME, 2014, (27): [11],. [J]., 2013, (1): Wu MM, Ma L. Research and application on the establishment of supplier quality capability assessment system [J]. Qual Tech Superv Res, 2013, (1): [12]. [J]., 2016, (7): 1. Wei CF. An unyielding, building the powerful nation [J]. Chin Food, 2016, (7): 1. [13]. [J]., 2014, (6): Jin ZN. Rational exploration of risk decision [J]. Contemp Law Rev, 2014, (6): [14],,. HACCP [J]., 2010, 41(8): Xu XH, Zhang X, Yan C. The application of HACCP in quality risk management of drugs [J]. Chin J Pharm, 2010, 41(8): [15],,,. [J]., 2011, 32(4): Luo JY, Li JJ, Chen ZF, et al. Study on risk management mechanism of import and export food safety [J]. Sci Technol Food Ind, 2011, 32(4): [16],. [J]., 2012, 11(2): Wang HJ, zhang J. Food security needs legal protection and moral constraints [J]. Ind Sci Trib, 2012, 11(2): [17]. [J]., 2014, (3): 311. Jin FZ. Construction and operation management system of agricultural product quality safety risk assessment [J]. Qual Saf Agro-Prod, 2014, (3): 311. [18]. [J]., 2012, 4(4): Liu XY. Risk assessment for nutrients and related substances [J]. Chin J Food Hyg, 2012, 4(4): [19]. [J]., 2010, (6): Ren ZH. Actuality analysis of Japan food safety supervision and management system [J]. Agric Econ, 2010, (6): 9394 [20],,,. [J]., 2013, 27(6): Li P, Yi LY, Wang S, et al. The present situation of quality standard of Chinese health food [J]. Chin Pharm Aff, 2013, 27(6): [21],. [J]., 2015, 34(5): Luo J, Zhang WJ. Study on risk identification and management strategy of food supply chains in China [J]. Log Technol, 2015, 34(5): [22],,,. [J]., 2015, 21(4): 59. Zhang XL, Zhang HY, Qian YZ, et al. Characteristics of agricultural products and safety risk communication and consumer s satisfaction [J]. Food Nutr China, 2015, 21(4): 59. [23] [C]., Ge JY. Characteristics and difficulties in the implementation of the 2010 edition of "drug production quality management standards" [C]. Sichuan Province, the Seventh Provincial Pharmaceutical Association Congress and Academic Annual Conference Proceedings, [24],. [C]. -, Cheng K, Xie J. A sound food safety standard system to create the most secure food city [C]. Market Practice Standardization, Standardization of the 11th Chinese BBS, [25]. [N]., (3). Li G. Attach importance to product quality to achieve quality and efficiency [N]. China Times, (3). [26]., [N]., (4). Liu H. Risk management, how to do it? [N]. China Metallurgical News, (4). [27],. [N].,

6, : ISO22000 C 2365 2011-06-14 (1). 作者简介 Deng WS, Dai HB. Put risk management into every aspect of the work [N]. China Aviation News, 2011-06-14 (1). [28]. ISO9001 ISO22000 [D]. :, 2006.

7 6, : ISO22000 C (1). 作者简介 Deng WS, Dai HB. Put risk management into every aspect of the work [N]. China Aviation News, (1). [28]. ISO9001 ISO22000 [D]. :, 冯波, 助理工程师, 主要研究方向为食品质量与安全管理 @qq.com Li Q. An empirical study on the implementation of ISO22000 standard by ISO9001 certified health food enterprises [D]. Jinan: Shandong University, ( 责任编辑 : 霍安琪 ) 陈强, 执业药师, 主要研究方向为食品质量与安全管理 [email protected]

我国原奶及乳制品安全生产和质量安全管理研究

我国原奶及乳制品安全生产和质量安全管理研究密级论文编号中国农业科学院硕士学位论文我国原奶及乳制品质量安全管理研究 Study on Quality and Safety Management of Raw Milk and Dairy Products in China 申请人 : 段成立指导教师 : 叶志华研究员张蕙杰研究员申请

Microsoft Word 冯 波 二校 2359

Microsoft Word 冯波二校 2359