J. FACILITIES – EQUIPMENT - MAINTENANCE   Estee Lauder/雅詩(shī)蘭黛驗(yàn)廠清單之設(shè)備保養(yǎng)

1.  Are the facilities adequate in design, size, and condition to produce the required materials?
     設(shè)施的設(shè)計(jì)，大小條件生產(chǎn)所需的材料是否充足？

2.  Is an effective, documented pest control program implemented and maintained?
     是否有有效的成文的害蟲防治項(xiàng)目正在實(shí)踐和維持

3.  Is there proper security to prevent unauthorized entry?
     是否有阻止未經(jīng)同意的進(jìn)入

4.  Are there records of the assessment of all utilities (e.g. air, gases, steam, water) for their potential impact on the quality of the product and any associated risks?
     所有的設(shè)施是否都有評(píng)估記錄（如空氣，氣體，蒸汽，水）為了保證其對(duì)產(chǎn)品質(zhì)量的潛在影響和任何相關(guān)的風(fēng)險(xiǎn)？

5.  Does the assessment include other fluids (e.g. lubrication fluids, cooling fluids, hydraulic oils, etc.), which may accidentally come into contact with the product? Depending on the risks, food-grade fluids should be considered
     無(wú)意中接觸到的物品是否經(jīng)過(guò)評(píng)估，包括其他液體（如潤(rùn)滑油，冷卻液，液壓油，等等），根據(jù)不同的風(fēng)險(xiǎn)，食品級(jí)液體應(yīng)考慮

6.  Where necessary are there appropriate ventilation and exhaust systems to minimize contamination? Particular attention shall be given to recirculation systems.
     在必要的地方是否有適當(dāng)?shù)耐L(fēng)和排氣系統(tǒng)，應(yīng)注重減少污染？應(yīng)特別重視再循環(huán)系統(tǒng)。

7.  Is the quality of water determined and controlled, if water comes into direct contact with primary components, or its starting material, or is used for cleaning the equipment in contact with the product?
     如果水與原部件，或它的起始材料直接接觸，或用于與產(chǎn)品接觸的設(shè)備清洗？水的質(zhì)量是否經(jīng)過(guò)確定和控制，

8.  Are there documented requirements for maintenance activities (e.g. production processes, systems and equipment), when such activities or lack thereof may affect product quality?
     是否有程序文件規(guī)定維護(hù)要求（如生產(chǎn)流程，系統(tǒng)和設(shè)備），如果缺乏這樣的程序是否可能影響產(chǎn)品質(zhì)量？

9.  Are records of maintenance maintained?
     維護(hù)記錄是否保存著

10.  Is the infrastructure managed, operated, cleaned and where appropriate, maintained in accordance with GMP to avoid product contamination?
      基礎(chǔ)設(shè)施的管理，操作，清洗和適當(dāng)?shù)木S護(hù)，是否按照GMP標(biāo)準(zhǔn)執(zhí)行，避免產(chǎn)品污染？

11.  Is a set of technical documentation for quality critical equipment and installations maintained?
      對(duì)于質(zhì)量關(guān)鍵設(shè)備和裝置維護(hù)是否有一套技術(shù)性文件