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ISO22716/GMP認(rèn)證如何管理廠房,咨詢公司

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最后更新: 2021-07-15 22:40:46
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    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(shè)計,建設(shè)和利用以:
    a) to ensure protection of the product;確保產(chǎn)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(shè)計,建設(shè)和利用以:
    a) to ensure protection of the product;確保產(chǎn)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(chǎn)品原料和包材交叉
    污染的風(fēng)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(shè)計的一些建議已經(jīng)在規(guī)范里描述了。設(shè)計時應(yīng)考慮化妝品的類型,工廠現(xiàn)狀、清潔設(shè)施(必要時考慮消毒設(shè)
    施)
    4.2 Types of area 區(qū)域類型
    Separate or defined areas should be provided for storage, production, quality control, ancillary, washing and toilets.
    儲存,生產(chǎn),質(zhì)量控制,輔助性設(shè)施,洗手區(qū)域和廁所等區(qū)域應(yīng)有隔離的或者指定區(qū)域
    4.3 Space 空間
    Sufficient space should be provided to facilitate operations such as receipt, storage and production. 應(yīng)提供足夠的空間,以
    便于實施操作,如收貨,儲存和生產(chǎn)
    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(chǎn)品,人員在建筑之間的流動應(yīng)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(chǎn)區(qū)域的地面,墻壁,天花板,窗戶應(yīng)設(shè)計為易清洗的,必要時可以消毒的,以保持清潔和良好狀態(tài)
    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(dāng)其中空氣流通充分時,窗應(yīng)該設(shè)計為不開啟的。如果窗是直接開向室外的,應(yīng)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(chǎn)區(qū)域的設(shè)計應(yīng)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(shè)施******************************************************************************************************************************************************************************************************************************************************************************************盥洗設(shè)施要提供給員工,應(yīng)與生產(chǎn)區(qū)域分開,但應(yīng)直接通向生產(chǎn)區(qū)。適當(dāng)時要提供淋浴和更衣設(shè)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(qū)域都應(yīng)安裝充足的光線適合作業(yè),
    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(yīng)采用萬一發(fā)生破損時不會對產(chǎn)品污染的方式。否則,要采取措施保護產(chǎn)品。
    4.8 Ventilation 通風(fēng)設(shè)備
    Ventilation should be sufficient for the intended production operations. Alternatively, specific measures should be taken to
    protect the product.
    在作業(yè)時通風(fēng)要充足,如果不能,要采取措施保護產(chǎn)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(chǎn)品,容器、設(shè)備表面。
    4.9.2 Drains should be kept clean and should not allow back flow.
    排水溝應(yīng)保持清潔而且不能回流
    4.9.3 Design considerations should be given to the following:設(shè)計所要考慮的
    a) exposed overhead roof beams, pipes and ducts should be avoided; 當(dāng)屋頂橫梁外露時,管道和排泄管應(yīng)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(chǎn)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(guī)范中描述的廠房應(yīng)該保持干凈狀態(tài)
    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(dá)到保護每個產(chǎn)品的目標(biāo)
    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(qū)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(guī)范中描述的廠房
    應(yīng)保持在一個良好的維護狀態(tài)
    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(chǎn)品質(zhì)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(shè)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(yīng)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(qū)域要采取措施以避免吸引害蟲

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