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ISO22716/GMP认证如何管理厂房,咨询公司
ISO22716/GMP认证如何管理厂房,咨询公司
来自:深圳市肯达信企业管理顾问有限公司
面议
发布时间:2021-7-15 关注次数:124
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规格型号 完善
编号 齐全
计量单位
付款方式 面议
价格单位 人民币
商品详情
4 Premises 厂房
4.1 Princi​‌‌ple 原则
4.1.1 Premises should be located, designed, constructed and utilized so as:要定位,设计,建设和利用以:
a) to ensure protection of the product;确保产品防护
b) to permit efficient cleaning, if necessary, sanitizing and maintenance;必要时,允许有效清洗,消毒和维修
c) to minimize the risk of mix-up ...更多4 Premises 厂房
4.1 Princi​‌‌ple 原则
4.1.1 Premises should be located, designed, constructed and utilized so as:要定位,设计,建设和利用以:
a) to ensure protection of the product;确保产品防护
b) to permit efficient cleaning, if necessary, sanitizing and maintenance;必要时,允许有效清洗,消毒和维修
c) to minimize the risk of mix-up of products, raw materials and packaging materials.*大程度降低产品原料和包材交叉
污染的风险
4.1.2 Premises design recommendations are described in these guidelines. Design decisions should be based on the type of
cosmetic product produced, existing conditions, cleaning and, if necessary, sanitizing measures used.
厂房设计的一些建议已经在规范里描述了。设计时应考虑化妆品的类型,工厂现状、清洁设施(必要时考虑消毒设
施)
4.2 Types of area 区域类型
Separate or defined areas should be provided for storage, production, quality control, ancillary, washing and toilets.
储存,生产,质量控制,辅助性设施,洗手区域和厕所等区域应有隔离的或者指定区域
4.3 Space 空间
Sufficient space should be provided to facilitate operations such as receipt, storage and production. 应提供足够的空间,以
便于实施操作,如收货,储存和生产
4.4 Flow 流动性
Flow of materials, products and personnel through the building or buildings should be defined in order to prevent mix-ups.
原料,产品,人员在建筑之间的流动应被确定以避免交叉污染
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4.5 Floors, walls, ceilings, windows 地面,墙壁,天花板,窗户
4.5.1 Floors, walls, ceilings and windows in production areas should be designed or constructed for ease of cleaning and, if
necessary, sanitization and be kept clean and in good repair.
生产区域的地面,墙壁,天花板,窗户应设计为易清洗的,必要时可以消毒的,以保持清洁和良好状态
4.5.2 Windows should be of non-opening design where ventilation is adequate. If windows are opened to the outside
environment, they should be properly screened.
当其中空气流通充分时,窗应该设计为不开启的。如果窗是直接开向室外的,应有纱窗。
4.5.3 New construction of production areas should incorporate considerations for proper cleaning and maintenance. Design
of new construction should include smooth surfaces if appropriate and these surfaces should allow for resistance to
corrosive cleaning and sanitizing agents.
新的生产区域的设计应考虑清洗和维修两点,包括光滑的表面并能抵抗腐蚀性清洗和消毒剂的作用
4.6 Washing and toilet facilities 盥洗设施******************************************************************************************************************************************************************************************************************************************************************************************盥洗设施要提供给员工,应与生产区域分开,但应直接通向生产区。适当时要提供淋浴和更衣设施。
4.7 Lighting 灯光
4.7.1 Adequate lighting, that is sufficient for operations, should be installed in all areas.
所有区域都应安装充足的光线适合作业,
4.7.2 Lighting should be installed in a manner to ensure containment of any debris from potential breakage.Alternatively,
measures should be taken to protect the product.
灯的安装方式应采用万一发生破损时不会对产品污染的方式。否则,要采取措施保护产品。
4.8 Ventilation 通风设备
Ventilation should be sufficient for the intended production operations. Alternatively, specific measures should be taken to
protect the product.
在作业时通风要充足,如果不能,要采取措施保护产品。
4.9 Pipework, drains and ducts 管道,排水沟,排泄管
4.9.1 Pipework, drains and ducts should be installed in such a manner so that drip or condensation does not contaminate
materials, products, surfaces and equipment.
安装时要考虑到水滴或冷凝水不能污染原料,产品,容器、设备表面。
4.9.2 Drains should be kept clean and should not allow back flow.
排水沟应保持清洁而且不能回流
4.9.3 Design considerations should be given to the following:设计所要考虑的
a) exposed overhead roof beams, pipes and ducts should be avoided; 当屋顶横梁外露时,管道和排泄管应避免
b) exposed pipes should not touch walls, but be suspended from or supported by brackets, sufficiently separated to allow
thorough cleaning;外露的管道不能接触墙,但可以由托架拖着或者吊着,要充分隔离以便彻底清洗
c) alternatively, specific measures should be taken to protect the product.否则,要采取措施保护产品。
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4.10 Cleaning and sanitization 清洗消毒
4.10.1 Premises used for activities described in these guidelines should be maintained in a clean condition.
规范中描述的厂房应该保持干净状态
4.10.2 Cleaning and, if necessary, sanitization should be carried out to achieve the objective of protecting each product.
清洗,必要时要消毒以达到保护每个产品的目标
4.10.3 Cleaning and, if necessary, sanitizing agents to be used should be specified and effective.清洗试剂必要时消毒试剂
要有说明并是有效的
4.10.4 There should be cleaning and, if necessary, sanitization programmes corresponding to specific needs of each area.
清洗消毒项目要符合各自区域的具体情况
4.11 Maintenance 维护
Premises used in activities described in these guidelines should be maintained in a good state of repair.规范中描述的厂房
应保持在一个良好的维护状态
4.12 Consumables 耗材
Consumables used for premises should not affect the quality of the product.
用于厂房维护的的耗材不能影响产品质量
4.13 Pest control 虫害控制
4.13.1 Premises should be designed, constructed and maintained so as to restrict access to insects, birds, rodents, pests and
other vermin.
厂房设计建造和和维护要能阻止昆虫,鸟儿,啮齿动物,虫害和其他害虫的进入。
4.13.2 There should be a pest control programme appropriate for the premises.
应有适合厂房建筑的虫害控制计划
4.13.3 Measures should be taken to control the exterior of the premises to prevent attracting or harbouring pests.
厂房外部区域要采取措施以避免吸引害虫
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