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當前位置: 首頁 » 供應產品 » 商務服務 » 其他商務服務 »ISO22716/GMP認證如何管理廠房,咨詢公司

ISO22716/GMP認證如何管理廠房,咨詢公司

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產品價格: 面議/人民幣 
最后更新: 2021-07-15 22:40:46
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    產品詳細說明
    4 Premises 廠房
    4.1 Princi?‌‌ple 原則
    4.1.1 Premises should be located, designed, constructed and utilized so as:要定位,設計,建設和利用以:
    a) to ensure protection of the product;確保產品防護
    b) to permit efficient cleaning, if necessary, sanitizing and maintenance;必要時,允許有效清洗,消毒和維修
    c) to minimize the risk of mix-up ...更多4 Premises 廠房
    4.1 Princi?‌‌ple 原則
    4.1.1 Premises should be located, designed, constructed and utilized so as:要定位,設計,建設和利用以:
    a) to ensure protection of the product;確保產品防護
    b) to permit efficient cleaning, if necessary, sanitizing and maintenance;必要時,允許有效清洗,消毒和維修
    c) to minimize the risk of mix-up of products, raw materials and packaging materials.*大程度降低產品原料和包材交叉
    污染的風險
    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.
    廠房設計的一些建議已經在規范里描述了。設計時應考慮化妝品的類型,工廠現狀、清潔設施(必要時考慮消毒設
    施)
    4.2 Types of area 區域類型
    Separate or defined areas should be provided for storage, production, quality control, ancillary, washing and toilets.
    儲存,生產,質量控制,輔助性設施,洗手區域和廁所等區域應有隔離的或者指定區域
    4.3 Space 空間
    Sufficient space should be provided to facilitate operations such as receipt, storage and production. 應提供足夠的空間,以
    便于實施操作,如收貨,儲存和生產
    4.4 Flow 流動性
    Flow of materials, products and personnel through the building or buildings should be defined in order to prevent mix-ups.
    原料,產品,人員在建筑之間的流動應被確定以避免交叉污染
    11
    4.5 Floors, walls, ceilings, windows 地面,墻壁,天花板,窗戶
    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.
    生產區域的地面,墻壁,天花板,窗戶應設計為易清洗的,必要時可以消毒的,以保持清潔和良好狀態
    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.
    當其中空氣流通充分時,窗應該設計為不開啟的。如果窗是直接開向室外的,應有紗窗。
    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.
    新的生產區域的設計應考慮清洗和維修兩點,包括光滑的表面并能抵抗腐蝕性清洗和消毒劑的作用
    4.6 Washing and toilet facilities 盥洗設施******************************************************************************************************************************************************************************************************************************************************************************************盥洗設施要提供給員工,應與生產區域分開,但應直接通向生產區。適當時要提供淋浴和更衣設施。
    4.7 Lighting 燈光
    4.7.1 Adequate lighting, that is sufficient for operations, should be installed in all areas.
    所有區域都應安裝充足的光線適合作業,
    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.
    燈的安裝方式應采用萬一發生破損時不會對產品污染的方式。否則,要采取措施保護產品。
    4.8 Ventilation 通風設備
    Ventilation should be sufficient for the intended production operations. Alternatively, specific measures should be taken to
    protect the product.
    在作業時通風要充足,如果不能,要采取措施保護產品。
    4.9 Pipework, drains and ducts 管道,排水溝,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.
    安裝時要考慮到水滴或冷凝水不能污染原料,產品,容器、設備表面。
    4.9.2 Drains should be kept clean and should not allow back flow.
    排水溝應保持清潔而且不能回流
    4.9.3 Design considerations should be given to the following:設計所要考慮的
    a) exposed overhead roof beams, pipes and ducts should be avoided; 當屋頂橫梁外露時,管道和排泄管應避免
    b) exposed pipes should not touch walls, but be suspended from or supported by brackets, sufficiently separated to allow
    thorough cleaning;外露的管道不能接觸墻,但可以由托架拖著或者吊著,要充分隔離以便徹底清洗
    c) alternatively, specific measures should be taken to protect the product.否則,要采取措施保護產品。
    12
    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.
    規范中描述的廠房應該保持干凈狀態
    4.10.2 Cleaning and, if necessary, sanitization should be carried out to achieve the objective of protecting each product.
    清洗,必要時要消毒以達到保護每個產品的目標
    4.10.3 Cleaning and, if necessary, sanitizing agents to be used should be specified and effective.清洗試劑必要時消毒試劑
    要有說明并是有效的
    4.10.4 There should be cleaning and, if necessary, sanitization programmes corresponding to specific needs of each area.
    清洗消毒項目要符合各自區域的具體情況
    4.11 Maintenance 維護
    Premises used in activities described in these guidelines should be maintained in a good state of repair.規范中描述的廠房
    應保持在一個良好的維護狀態
    4.12 Consumables 耗材
    Consumables used for premises should not affect the quality of the product.
    用于廠房維護的的耗材不能影響產品質量
    4.13 Pest control 蟲害控制
    4.13.1 Premises should be designed, constructed and maintained so as to restrict access to insects, birds, rodents, pests and
    other vermin.
    廠房設計建造和和維護要能阻止昆蟲,鳥兒,嚙齒動物,蟲害和其他害蟲的進入。
    4.13.2 There should be a pest control programme appropriate for the premises.
    應有適合廠房建筑的蟲害控制計劃
    4.13.3 Measures should be taken to control the exterior of the premises to prevent attracting or harbouring pests.
    廠房外部區域要采取措施以避免吸引害蟲

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