22716的定義：
2011年4月21日，歐盟官方公報上發布了《EN ISO 22716: 2007化妝品—良好生產操作(GMP) —良好生產操作指南》(ISO 22716: 2007)，公告該指南正式成為歐盟化妝品法規(EC) No 1223/2009的GMP協調標準，也就是說，符合EN ISO 22716: 2007即表示符合了歐盟化妝品法規的GMP要求。歐盟第一部化妝品法規Regulation（EC）1223/2009於2013年7月11日在27個歐盟成員國（以及挪威、冰島和列支敦斯登）中作為國家法律正式實施，而不像之前的化妝品指令76/768 EEC那樣在各國執行前需要轉換。該法規對化妝品的安全性提出了更加嚴格的要求，其中明確了產品責任人將承擔更多的法律責任，EN ISO 22716也即符合此歐盟新法規（EC）1223/2009涉及GMP的要求。
國際化妝品監管合作組織（International Cooperation on Cosmetic Regulation，ICCR）是美國食品藥品管理局、日本厚生勞動省、歐洲聯盟的歐洲委員會企業總局和加拿大衛生部的政府化妝品監管理部門組成的國際組織。ICCR於2008年7月在美國的華盛頓召開了第二次會議。會上，各國監管機構同意儘可能在各自地區實施ISO 22716標準。具體情況如下：美國同意考慮ISO 22716國際標準和修改現有的FDA的指導原則。歐盟將實施歐盟標準化委員(European Committee for Standardization，CEN)會通過的 TC 217/ISO 22716國際標準。加拿大同意考慮ISO 22716國際標準，並期待採用ICCR-3的自願GMP標準。日本通知地方政府，日本化學工業協會（Japan Chemical Industry Association，JCIA）採用ISO 22716 國際標準。
22716的內容：
INTERNATIONASTANDARD L
國際標準
ISO22716
First edition2007-11-15
第一版本發行於2007 年 11 月 15 日
Cosmetics — Good Manufacturing Practices (GMP) — Guidelines on Good Manufacturing Practices
化妝品—良好生產規範（GMP）準則
ISO 22716:2007(E)
標準號
ISO22716:2007(E)
1ContentsPage
Introduction
目錄.1
1 Scope 範圍.1
2 Terms and definitions 術語和定義1
3 Personnel員工....4
4 Premises 廠房6
5 Equipment 設備....8
6 Raw materials and packaging materials 原料和包材10
7 Production生產 ...11
8 Finished products成品..14
9 Quality control laboratory實驗室質量控制制.15
10 Treatment of product that is out of specification不合格品的處 理.... 17
11 Wastes廢棄物 ...17
12 Subcontracting外包18
13 Deviations偏差19
14 Complaints and recalls 投訴和召回.19
15 Change control變更控制.19
16 Internal audit內審 20
17 Documentation文檔20
Introduction
These guidelines are intended to provide guidance regarding Good Manufacturing Practices for cosmetic products. These guidelines have been prepared for consideration by the cosmetic industry and take into account the specific needs of this sector. These guidelines offer organizational and practical advice on the management of the human, technical and administrative factors affecting product quality.
These guidelines have been written to allow them to be used following the flow of products from receipt to shipment. Additionally, in order to clarify the way this document reaches its objectives, a 『principle』 is added to each major section.
Good Manufacturing Practices constitute the practical development of the quality assurance concept through the description of the plant activities that are based on sound scientific judgement and risk assessments. The objective of these GMP guidelines is to define the activities that enable you to obtain a product that meets defined characteristics. Documentation is an integral part of Good Manufacturing Practices.
介紹
這份準則為化妝品良好生產規範做出指導，是適合化妝品行業並考慮了行業的具體要求，在人
員，技術和影響產品質量的綜合因素方面提供了系統性的和實際性的建議。
這個指導是為了讓員工遵守產品接收到裝運的流程下如何去利用資源。為了達到此目的，在每
一個章節裡都添加了「原則」這一欄。
良好生產規範中的質量保證發展觀念是通過描述建立在科學有效的判定和風險評估上的工廠活
動來完成的，這份準則的目的是為了界定能讓你獲得達標產品的活動。
文件是 GMP 不可或缺的一部分。
ISO22716:2007(E)
化妝品良好生產規範準則
1 Scope 範圍
This International Standard gives guidelines for the production, control, storage and shipment of cosmetic products 此國際標準為化妝品生產，控制，儲存和裝運提供指南
These guidelines cover the quality aspects of the product, but as a whole do not cover safety aspects for the personnel engaged in the plant, nor do they cover aspects of protection of the environment. Safety and environmental aspects are inherent responsibilities of the company and could be governed by local legislation and regulation.這個標準包含產品質量的各個方面但不包括員工安全和對環境的保護方面，安全和環境保護是公司的應的責任，可以通過當地的法律和法規加以管制
These guidelines are not applicable to research and development activities and distribution of finished products. 這些準則並不適用於設計和開發和產品營銷活動。
2 Terms and definitions 術語和定義
For the purposes of this document, the following terms and definitions apply.以下術語和定義對於本文件是適用的.
2.1 acceptance criteria 接收標準
numerical limits, ranges, or other suitable measures for acceptance of test results 數值限度，範圍或者其他可作為接受測試結果的方法
2.2 audit 審核
systematic and independent examination to determine whether quality activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable for achieving objectives為獲得審核證據並對其進行客觀評價，以確定滿足審核准則的程度而進行的 系統的、獨立的、形成文件的過程。
2.3 Batch 批
defined quantity of raw material, packaging material or product issued from one process or series of processes so that it could be expected to be homogeneous從某個或多個操作獲得的、認為是一致的特定數量的原料，包材或產品。
2.4 batch number 批號
distinctive combination of numbers, letters and/or symbols, which specifically identifies a batch 單個數字，字母，或字母和數字結合的，用來指定識別一批產品的代碼.
2.5bulk produc 散裝產品
any product which has completed manufacturing stages up to, but not including, final packaging 經過所有製造工藝過程的產品，除了沒有填充到獨立包裝的產品。
2.6Calibration 校準
set of operations that establish, under specified conditions, the relationship between values indicated by a measuring instrument or measuring system, or values represented by a material measure, and the corresponding known values of a reference standard在特定條件下，通過一系列操作在測量儀器或測量系統所指示的量值，或事物量具或參考事物表示的值，和按標準實現的相應值間建立起一種關係。
2.7 change control 變更控制
internal organization and responsibilities relative to any planned change of one or several activities covered by the Good Manufacturing Practices in order to ensure that all the manufactured, packaged, controlled and stored products correspond to the defined acceptance criteria為確保生產，包裝，控制，儲存符合接收標準，組織所作的內部機構、職責與 GMP 內容有關的任何計劃的變動。
2.8Cleaning 清洗
all operations that ensure a level of cleanliness and appearance, consisting of separating and eliminating generally visible dirt from a surface by means of the following combined factors, in variable proportions, such as chemical action, mechanical action, temperature, duration of application為確保達到潔淨水平，隔離或消除表面贓物的所有操作。例如用化學作用，機械作用，溫度，時間等方法。
2.9Complaint 投訴
external information claiming a product does not meet defined acceptance criteria 外部信息斷言成品有質量缺陷。
2.10Contamination 接觸汙染
occurrence of any undesirable matter such as chemical, physical and/or microbiological matter in the product 指在產品中發現任何不應出現化學的，物理的，生物的物質的事件。
2.11Consumables 耗材
materials such as cleaning agents and lubricants that are used up during cleaning, sanitization ormaintenance operations指某些在清潔、消毒或維護中消耗的材料諸如清潔劑、潤滑油等。
2.12contract acceptor 受託方
person, company or external organization carrying out an operation on behalf of another person, company or organization 代表某人、公司、組織實施操作的個人、公司或外部的組織。
2.13Control 控制
verification that acceptance criteria are met 確認可接受準則得到滿足
2.14Deviation 偏差
internal organization and responsibilities relative to the authorization to deviate from specified requirements due to a planned or unplanned and, in any case, temporary situation concerning one or several activities covered by the Good Manufacturing Practices由於計劃的或非計劃的臨時情況，組織和職責偏離了 GMP 所覆蓋的一個或多個活動的特定要求。
2.15finished product 成品
cosmetic product that has undergone all stages of production, including packaging in its final container, for shipment。化妝品產品經歷了所有的生產階段，包括在其最後的容器包裝，出貨。
2.16in-process control 過程控制
controls performed during production in order to monitor and, if appropriate, to adjust the process to ensure that the product meets the defined acceptance criteria對生產過程進行監控，如果需要可對過程進行調整以確保產品達到可接受準則。
2.17internal audit 內審
systematic and independent examination made by competent personnel inside the company, the aim of which is to determine whether activities covered by these guidelines and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable for achieving objectives由內部有能力的人員實施的系統和獨立的檢查，目的是為了確定活動是否覆蓋了與指南和策劃的相關結果，以及這些安排是否得到有效實施並適用於實現目標。
2.18major equipment 主要設備
equipment specified in production and laboratory documents which is considered essential to the process 在生產和實驗室文件中詳細說明的，被認為是對加工必不可少的設備
2.19Maintenance 維護
any periodic or unplanned support and verification operations designed to keep premises and equipment in proper working condition 為了保持房屋和設備處於適宜的工作狀態所實施的定期或非計劃的維護和驗證檢查。
2.20manufacturing operation 製造過程
set of operations from the weighing of raw materials to the making of the bulk product 從原料的稱量到散裝產品的製造必走的過程
2.21out-of-specification 超出規格
examination, measurement or test result that does not comply with defined acceptance criteria 檢查，測量或測試的結果不符合規定的可接收標準
2.22packaging operation 包裝過程
all packaging steps including filling and labelling, which a bulk product has to undergo in order to become a finished product 所有包裝步驟包括填充，就是散裝產品到成品必走的過程
2.23packaging material 包材
any material employed in the packaging of a cosmetic product, excluding any outer packaging used for transportation 任何用於包裝產品的包裝材料，除了用於運輸的外包裝
NOTE Packaging materials are referred to as primary or secondary according to whether or not they are intended to be in direct contact with the product.注意：包材可分為第一和第二材料根據它們是否與產品直接接觸
2.24Plant 工廠
location for production of cosmetic products 化妝品廠的位置。
2.25Premises 廠房
physical location, buildings and supporting structures used to conduct receipt, storage, manufacturing, packaging, control and shipment of product, raw materials and packaging materials
7物理位置，建築物和支撐結構，用於實施接收，儲存，製造，包裝，控制和產品，原料，包材運輸等活動
2.26production 生產
manufacturing and packaging operations 製造和包裝過程
2.27quality assurance 質量保證
all those planned and systematic activities necessary to provide confidence that a product satisfies given acceptance criteria 為了確保產品符合標準所進行的計劃和系統的活動。
2.28raw material 原料
any substance going into or involved in the manufacturing of a bulk product 製造一個散裝產品所引入的或有關的物質
2.29Recall 召回
decision made by a company to call back a product batch that has been put on the market 決定從市場上回收某個批次的產品。
2.30Reprocessing 返工
re-treatment of all or part of a batch of finished product or bulk product of an unacceptable quality from a defined stage of production so that its quality may be rendered acceptable by one or more additional operations對確定生產階段的所有或部分不合格成品或散裝產品重新加工以讓其允收。
2.31Return 返回
sending finished cosmetic products which may or may not present a quality defect back to the plant 將可能有或沒有質量缺陷的成品退回工廠。
2.32Sample 樣品
one or more representative elements selected from a set to obtain information about that set 從一批裡選擇出的一個或多個具有典型要素的，可以獲得那批信息的產品
2.33Sampling 抽樣
set of operations relating to the taking and preparation of samples 操作中涉及選擇和準備樣品的活動。
2.34Sanitization 消毒
operation, used to reduce undesirable micro-organisms on inert contaminated surfaces depending on the objectives set NOTE It is the action of reducing generally invisible contaminants from a surface在鈍化的被汙染的表面實施的操作，目的是減少不良微生物。註：它是一個減少通常不可見的汙染的操作。
2.35Shipment 裝運
set of operations relative to the preparation of an order and its putting in a transport vehicle 有關訂單的準備和裝入運輸工具的一系列行為。
2.36Waste 廢棄物
any residue of a production operation, transformation or use, any substance, material, product that its holder intends for disposal生產過程產生的或轉化而成的，或者使用後的原料，產品等需要廢棄的任何物質。
3 Personnel 員工
3.1 Principle 原則
Persons involved in the implementation of the activities described in these guidelines should have appropriate training to produce, control and store products with a defined quality.任何規範中提到的參與活動的人員應具備生產，控制，儲存合格品的訓練技能
3.2 Organization 組織
3.2.1 Organization chart 組織結構
3.2.1.1 The organizational structure should be defined in order that the organization and functioning of the staff of the company be understandable. It should be appropriate for the size of the company and the diversity of its products.應制定組織結構，以確保公司組織和員工職能能被理解，組織機構應適合公司的規模和產品的多樣性
3.2.1.2 Each company should ensure that there are adequate staffing levels in the different scope of activity, according to the diversity of its production.根據產品多樣性，每個公司應確保在活動的不同範圍都有充足的員工
3.2.1.3 The organization chart should show the independence, from the other units of the plant, of each quality unit, such as quality assurance unit and quality control unit. The quality assurance and quality control responsibilities can be undertaken by a separate quality assurance unit and a quality control unit, or they can be undertaken by a single unit.組織機構應表明質量保證和質量控制的部門獨立於工廠的其它部門，質量保證和質量控制的職責可以分成兩個也可以合併成一個。
3.2.2 Number of people 員工數量
The company should have an adequate number of properly trained personnel with regards to the defined activities in these guidelines.公司應該有一定數量的經過適當有關這個規範培訓的員工
3.3 Key responsibilities 主要職責
3.3.1 Management responsibilities 管理職責
3.3.1.1 The organization should be supported by the top management of the company.組織應當得到這個公司最高管理的支持
3.3.1.2 The implementation of Good Manufacturing Practices should be the responsibility of top management and should require the participation and commitment of personnel in all departments and at all levels within the company.GMP 的實施是最高管理階層的職責並且需要所有部門和每個員工的支持和參與
3.3.1.3 Management should define and communicate the areas in which authorized personnel are allowed to access.管理職責需要確定相關人員的授權並與之溝通
3.3.2 Responsibilities of personnel 個人職責
All personnel should:每個人都應;
a)know their position in the organizational structure 知道自己在組織結構中的位置
b)know their defined responsibilities and activities;知道被規定的責任和行為
c)have access to and comply with documents relevant to their particular responsibility scope;有機會獲得並符合其特殊的職責範圍的文件
d)comply with personal hygiene requirements; 遵守個人衛生要求
e)be encouraged to report irregularities or other non-conformities which may occur at the level of their responsibilities;被鼓勵報告非法或不符規定的可能發生在他們職責範圍的行為
f)have adequate education training and skills to perform the assigned responsibilities and activities.有足夠的教育背景和技能從而勝任規定的職責和活動
3.4 Training 培訓
3.4.1 Training and skills 培訓和技能
Personnel involved in production, control, storage and shipment should have skills based on relevant training and experience acquired, or any combination thereof, that are appropriate to their responsibilities and activities.
涉及生產，控制，儲存和裝運的員工要有相關的培訓和經驗，或者其他任何適合其工作的等等
3.4.2 Training and Good Manufacturing Practices 培訓和良好生產規範
3.4.2.1 Appropriate Good Manufacturing Practices training relative to the defined activities of these guidelines should be provided for all personnel.良好生產規範培訓都要提供給每個人
3.4.2.2 The training needs of all personnel, regardless of level or seniority in the company, should be identified and a corresponding training programme should be developed and implemented.這個每個人需要培訓，不管什麼水平和位置，所相應的培訓項目要產生並且實施
3.4.2.3 Considering the expertise and experience of the respective personnel, training courses should be tailored to be appropriate to the jobs and responsibilities of individuals.考慮到每個員工的特長和經驗不同，培訓可以根據每個人的工作和職責來設定
3.4.2.4 According to the needs and in-house resources available, training courses may be designed and executed by the company itself or with the help of expert external organizations, if necessary.根據需要和現有的可利用資源，培訓課程可由公司自己編制或由外部專業人士編寫
3.4.2.5 Training should be regarded as a constant and on-going process that is subject to regular updates.
培訓應該是持續的並能及時更新
3.4.3 Newly recruited personnel 新員工招聘
Besides basic training on the theory and practice of Good Manufacturing Practices, newly recruited personnel should receive training appropriate to the duties assigned to them.除了基本的理論和 GMP 培訓，新員工還要他們崗位的培訓
3.4.4 Personnel training evaluations 個人培訓評估
Knowledge accumulated by personnel should be evaluated during and/or after training .在培訓過程中或者過後，個人知識的積累需進行評估
3.5 Personnel hygiene and health 個人衛生和健康
3.5.1 Personnel hygiene 個人衛生
3.5.1.1 Hygiene programmes should be established and adapted to the needs of the plant. These
requirements should be understood and followed by every person whose activities take them into production, control and storage areas.就建立衛生程序並滿足工廠的需要，在生產，控制，儲存區域工作的人員要理解這些要求並且遵守
3.5.1.2 Personnel should be instructed to use hand washing facilities .每個人要被指導如何使用洗手設備
3.5.1.3 Every person entering production, control and storage areas should wear appropriate clothing and protective garments to avoid contamination of cosmetic products.進入生產，控制，儲存區域人員要穿好防護衣從而避免汙染產品
3.5.1.4 Eating, drinking, chewing, smoking or the storage of food, drink or smoking materials or personal medication in the production, control and storage areas should be avoided.
應避免在生產，控制，儲存區域吃東西、喝水、吃口香糖、抽菸、儲存食物，個人藥品。
3.5.1.5 Any unhygienic practice within the production, control and storage areas or in any other area where the product might be adversely affected should be forbidden.任何不衛生的行為都不能出現在生產，控制，儲存區域或者對產品造成影響的區域
3.5.2 Personnel health 個人健康
Steps should be taken to ensure, as far as is practicable, that any person affected by an apparent illness or having open lesions on the exposed body surface should be excluded from direct contact with product until the condition is corrected or determined by medical personnel that the quality of cosmetic products will not be compromised.任何適用的措施應該採取以確保病人和在皮膚暴露部位有開放性傷口的人員不得直接接觸產品，直到情況改善或者醫療人員確認後，這樣才能確保產品不受影響
3.6 Visitors and untrained personnel 來訪者和未被培訓的人員
Visitors or untrained personnel should preferably not be taken into production, control and storage areas. If this is unavoidable, they should be given information in advance, particularly about personal hygiene and the prescribed protective clothing. They should be closely supervised.這些人不能進入生產，控制，儲存區域，如果不得不進入，他們需要被提前告知一些信息，特別是個人衛生和防護服規定。他們應被密切的指導。
4 Premises 廠房
4.1 Principle 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.最大程度降低產品原料和包材交叉汙染的風險
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範裡描述了。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，以便於實施操作，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，人員在建築之間的流動應被確定以避免交叉汙染
11
4.5 Floors, walls, ceilings, windows 地面，牆壁，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，牆壁，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，包括光滑的表面並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
Adequate, clean, washing and toilet facilities should be provided for personnel. The washing and toilet facilities should be differentiated from, but accessible to, production areas. Adequate facilities for showering and changing clothes should be provided when appropriate.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.燈的安裝方式應採用萬一發生破損時不會對產品汙染的方式。否則，要採取措施保護產品。
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，要採取措施保護產品。
4.9 Pipework, drains and ducts 管道，排水溝，排洩管
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汙染原料，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，管道和排洩管應避免
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牆，但可以由託架拖著或者吊著，要充分隔離以便徹底清洗
c) alternatively, specific measures should be taken to protect the product.否則，要採取措施保護產品。
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. 規範中描述的廠房應該保持乾淨狀態
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並是有效的
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.規範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.
用於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，齧齒動物，蟲害和其他害蟲的進入。
4.13.2 There should be a pest control programme appropriate for the premises.
應有適合廠房建築的蟲害控制計劃
4.13.3 Measures should be taken to control the exterior of the premises to prevent attracting or harbouring pests.
廠房外部區域要採取措施以避免吸引害蟲。
5 Equipment 設備
5.1 Principle 原則
Equipment should be suitable for the intended purpose and capable of being cleaned and, if necessary, sanitized and maintained. This clause applies to all equipment within the scope of these guidelines. If automated systems are introduced into activities described in these guidelines, they should take into account the application of the given relevant principles.設備應滿足預期的目的，便於被清洗，必要時可以消毒和維護。本條例適合本規範裡所有的設備，如果自動化系統被引進在這個規範所提到的活動中，那麼就要考慮相關條款的適用性。
5.2 Equipment design 設備的設計
5.2.1 Production equipment should be designed to prevent contamination of the product.
選擇、設計的生產設備類型需確保不會對產品產生汙染。
5.2.2 Bulk product containers should be protected from air contaminants, such as dust and moisture.
散裝產品的儲存容器應防止空氣汙染物，如灰塵和水汽。
5.2.3 Transfer hoses and accessories that are not in use should be cleaned and, if necessary sanitized,kept dry and protected from dust, splash or other contamination.連接軟管和配件不用時要清潔必要時消毒，保持乾燥並防止灰塵水漬和其他汙染物的汙染
5.2.4 The material used in the construction of equipment should be compatible with products and the cleaning and sanitizing agents.設備自身的材料不能和產品，清洗消毒試劑起反應
5.3 Installation 安裝
5.3.1 The design and the installation of equipment should ease its drainage in order to facilitate cleaning and sanitization. 設備的設計和安裝要方便排水從而易於清洗消毒。
5.3.2 Equipment should be placed so that movement of materials, mobile equipment and personnel do not pose a risk to quality.設備應放在不影響原料的轉移，設備和人員移動的地方從而不會對產品質量產生風險。
5.3.3 Reasonable access under, inside and around equipment should be provided for maintenance and cleaning.在設備的下面，裡面和周圍要有合理的空間以方便清洗消毒。
5.3.4 Major equipment should be readily identifiable.主要設備能容易的被識別出來。
5.4 Calibration 校準
5.4.1 Laboratory and production measuring instruments that are important for the quality of the product, should be calibrated regularly.與生產、產品質量控制重要的實驗和生產的測量設備，應被定期校準
5.4.2 If results of calibration are out-of-acceptance criteria, measuring instruments should be appropriately identified and removed from service.如果校準結果超出標準，那麼這個測量設備要被標識，並不能使用。
5.4.3 An out-of-calibration condition should be investigated to determine if there is any impact to the quality of the product and appropriate steps taken based on this investigation.需要分析超出校準的原因，以確定是否對產品質量造成影響，並且需要採取消除其影響的相應的措施。
5.5 Cleaning and sanitization 清洗消毒
5.5.1 All equipment should be subject to an appropriate cleaning and, if necessary, sanitization programme.
所有設備需適合清洗消毒
5.5.2 Cleaning and sanitizing agents should be specified and effective.清洗消毒試劑要有說明並且是有效的
5.5.3 Where equipment is assigned to continuous production or production of successive batches of the same product, equipment should be cleaned and, if necessary, sanitized at appropriate intervals.如果設備被安排持續生產或同種產品的連續生產，應對其進行清潔，必要時在適宜的間隔進行消毒。
5.6 Maintenance 維護保養
5.6.1 Equipment should be regularly maintained.設備應定期保養
5.6.2 Maintenance operations should not affect the quality of the product.保養項目不能影響產品質量
5.6.3 Defective equipment should be identified accordingly, excluded from use and isolated if possible故障的設備應被標識並且不能再使用，如果可能進行隔離。
5.7 Consumables 設備耗材
Consumables used for equipment should not affect the quality of the product.用於設備的耗材不能影響產品質量
5.8 Authorizations 使用授權
Equipment or automated systems used in production and control should be accessed and used by authorized personnel. 設備或用在生產和控制的自動化系統應通過授權的人員訪問和使用
5.9 Back-up systems 系統備份
Adequate alternative arrangements should be available for systems which need to be operated in the event of a failure or breakdown.當作業系統失敗和故障時，適當的替代安排應可獲得。
6 Raw materials and packaging materials 原料和包材
6.1 Principle 原則
Raw materials and packaging materials that are purchased should meet defined acceptance criteria relevant to the quality of finished products採購的原料和包材要符合成品質量標準。
6.2 Purchasing 採購
Purchasing of raw materials and packaging materials should be based on:採購原料和包材時要建立在以下基礎上
a)evaluation and selection of the supplier;對供應商的評估和選擇
b)establishment of technical clauses such as type of selection to be conducted, acceptance criteria, actions in the case of defect or modifications, transport conditions;要制訂技術文件，諸如：選擇類型，接收準則，在出現缺陷的行動和修改，運輸狀況等情況時所採取的相應措施（行動）。
c)setting of relations and exchanges between the company and supplier such as questionnaire, assistance and audits.建立公司和供應商之間的溝通、交流渠道，如通過問卷調查，協助和審核。
6.3 Receipt 接收
6.3.1 The purchase order, the delivery note and the delivered materials should match 用於採購的訂單號，送貨單，運輸的材料信息要匹配
6.3.2 The integrity of the raw materials and packaging materials shipping containers should be checked visually. If necessary, additional checks of transport data should be performed.
需檢查運送原材料和包裝材料的包裝是否完整。必要時，檢查傳遞的數據信息
6.4 Identification and status 識別和狀態
6.4.1 Containers of raw materials and packaging materials should be labelled in order to identify the material and the batch information.盛放原料和包材的容器需被標識以能識別材料和批號信息
6.4.2 Raw materials and packaging materials showing defects that might affect product quality should be held pending a decision.原料和包材如果有可能影響產品質量的缺陷應待定。
6.4.3 Raw materials and packaging materials should be identified in an appropriate way according to their status such as accepted, rejected or quarantined. Other systems can replace this physical system of identification, if they ensure the same level of assurance.包材和原料應當標識接受，拒絕，待檢狀態，如果能達到相同的目的，其它識別系統也可以代替。
6.4.4 Identification of raw materials and packaging materials should contain the following information:原料和包材識別應包含以下信息
a)name of the product marked on the delivery note;產品名稱要標記在送貨單上
b)name of the product as given by the company, if different from the name given by the supplier and/or its code number;如果產品名稱和供應商提供的不一樣，工廠提供的產品名稱。
c)date or number of receipt, if appr opriate;適宜時，接收日期和數量
d)supplier name;供應商名稱
e)batch reference given by the supplier and the one given at receipt, if different.註明供應商提供的批號和接受到的批號。（如果兩者不同）
6.5 Release 放行
6.5.1 Physical or alternative systems should be set up to ensure that only released raw materials and packaging materials are used.應設置物理區域（倉庫合格區存放區）或可選擇的系統（識別狀態系統），以確保只有批准放行的原材料和包裝材料才可以使用。
6.5.2 The release of materials should be carried out by the authorized personnel responsible for quality. 相關人員要對發放的原料和包材質量負責
6.5.3 Raw materials and packaging materials can be accepted on the basis of the supplier certificate of analysis only if there are established technical requirements, experience and knowledge of the supplier, supplier audit and agreed supplier test methods.只有在建立了技術要求、供應商經驗和知識、供應商審核和認可了供應商的測試方法時，審核原料和包材產品檢測證明接收才可以接受
6.6 Storage 儲存
6.6.1 Storage conditions should be appropriate for each raw material and packaging material.儲存條件要適合於原料和包材。
6.6.2 Raw materials and packaging materials should be stored and handled in a manner appropriate to their characteristics.根據原料和包材的特性進行處理和儲存
6.6.3 Specific storage conditions should be respected and monitored, where appropriate.在適當情況下，具體的儲存條件應當得到遵守和監控。
6.6.4 Containers of raw materials and packaging materials should be closed and should be stored off the floor.
包裝原料和包材的容器應被封口並離地面儲存。
6.6.5 When raw materials and packaging materials are repacked, they should carry the same labelling as at origin.如果原料和包材被再次包裝，其批號等信息要和最原始的保持一致。
6.6.6 When raw materials and packaging materials are quarantined or rejected, they should be stored in their respective physical locations or by using any other system providing the same level of assurance.當原料和包材待檢或拒絕，它們要被儲存在各自的適合條件下，或者可以採用其它方法來處理，如果能達到相同效果。
6.6.7 Measures should be set up to ensure stock turnover. Except in special circumstances, stock rotation should ensure that the oldest released stock is used first.應確保存貨周轉，除了特殊情況，要保證先進先出原則。
6.6.8 Periodic inventory should be performed to ensure stock reliability. Any significant discrepancy should be investigated and corrective action taken.定期盤點時為了確保庫存的可信度，任何重大的不符應被調查並採取糾正行動。
6.7 Re-evaluation 重新評估
A system should be set up to re-evaluate materials as appropriate to determining their suitability for use, after a defined period of storage. The system should be set up so as to prevent the use of materials which require re-evaluation.應建立體系以重新評估在儲存一段時間後儲存的物資是否可用。體系也應明確防止未重新評估就使用的情況
6.8 Quality of water used in production 生產用水質量
6.8.1 The water treatment system should supply a defined quality of water.水處理系統要提供符合質量要求的水
6.8.2 Water quality should be verified by either testing or monitoring of process parameters.通過測試和過程參數的監測來核實水質
6.8.3 The water treatment system should permit sanitization.水處理系統應消毒
6.8.4 Water treatment equipment should be set up so as to avoid stagnation and risks of contamination.為了避免水停滯和汙染的風險要具備水處理裝備
6.8.5 Materials used in water treatment equipment should be selected to ensure that water quality is not affected.用於水處理的材料要保證不能影響水質
7 Production 生產
7.1 Principle 原則
At each stage of manufacturing operations and packaging operations, measures should be taken to produce a finished product that meets the defined characteristics.在生產和包裝的每個過程，需採取一些措施確保成品達到要求。
7.2 Manufacturing operations 製造作業
7.2.1 Availability of relevant documents 相關文件的有效性
7.2.1.1 Relevant documentation should be available at each stage of manufacturing operations相關文件在每個生產操作中是可行的
7.2.1.2 Manufacturing operations should be carried out according to manufacturing documentation,including:
根據相關文件進行下列操作：
a)suitable equipment;適合的設備
b)formula for the product;產品配方
c)list of all raw materials identified according to relevant documents indicating batch numbers and quantities;根據相關文件指示的批號和數量，經確定的原料清單。
d)detailed manufacturing operations for each stage, such as addition of raw materials, temperatures, speeds, mixing times, sampling, cleaning and, if necessary, sanitizing of equipment, and bulk product transfer.生產過程的各個細節，如原料的添加、溫度控制、轉速、混合時間、抽樣、清洗、必要時消毒設備、散裝產品的轉移等。
7.2.2 Start-up checks 生產前的檢查
Before starting any manufacturing operations, it should be ensured that:生產前要確保：
a)all documentation relevant to the manufacturing operations is available;所有相關文件要到位
b)all raw materials are available and released;所有原料是可使用的並被放行。
c)suitable equipment is available for use, in working order, cleaned and, if necessary, sanitized;設備可用並可以清洗和消毒
d)clearance of the area has been performed to avoid mixing with materials from previous operations.上一個操作完畢後要對所在區域進行清潔以避免交叉汙染
7.2.3 Assignment of a batch number 確定批號
A batch number should be assigned to each batch of manufactured bulk product. This number does not need to be identical with the batch number that appears on the label of the finished product, but, if not, it should be easy to relate to that number.應指定散裝產品的批號，雖然並不需要和成品上的批號完全相同，但應當與成品的批號相關聯。
7.2.4 Identification of in-process operations 過程操作的確認
7.2.4.1 In accordance with the formula, all raw materials should be measured or weighed, into clean and suitable containers labelled with appropriate identification or directly into the equipment used for manufacturing.
根據配方，所有的原料都應被計量或稱量，投入於乾淨適合的有適當標識的容器裡或者直接投在生產設備當中。
7.2.4.2 At all times, it should be possible to identify major equipment, containers of raw materials and containers of bulk products.在任何時候都需識別主要設備，盛原料和散裝產品的容器。
7.2.4.3 Identification of containers of bulk products should indicate:盛散裝產品的容器的標識：
a)name or identifying code;名稱和識別碼
b)batch number;批號
c)storage conditions when such information is critical to assure the quality of the product.當此信息對產品質量重要時標識儲存條件
7.2.5 In-process control 過程控制
7.2.5.1 In-process controls and their acceptance criteria should be defined.
過程控制及其可接受準則應確定
7.2.5.2 In-process controls should be performed according to a defined programme.
過程控制要按確定的程序進行
7.2.5.3 Any result outside the acceptance criteria should be reported and appropriately investigated.
要報告任何超出規定的結果並做分析
7.2.6 Bulk product storage 散裝產品儲存
7.2.6.1 Bulk product should be stored in suitable containers, in defined areas, and under appropriate conditions.散裝產品要儲存在適合的容器內，特定的區域，適合的條件下。
7.2.6.2 The maximum bulk product storage duration should be defined.設定散裝產品最大儲存有效期
7.2.6.3 When this duration is reached, the bulk product should be re-evaluated before use.當達到有效期時，使用前需對散裝產品進行再評估
7.2.7 Re-stocking raw materials 原料再儲存
If raw materials remain unused after weighing and are intended and deemed acceptable to return to stock, their containers should be closed and properly identified.稱量後未用的剩下原料返還到倉庫時要被標識，並且盛裝的容器要被封口和標識。
7.3 Packaging operations 包裝作業
7.3.1 Availability of documents 相關文件的有效性
7.3.1.1 Relevant documentation should be available at each stage of packaging operations.相關文件在每個生產操作中是可獲得
7.3.1.2 Packaging operations should be carried out according to packaging documentation including:根據相關文件進行操作，這些文件應包括：
a)suitable equipment;適合的設備
b)list of packaging materials defined for the intended finished product;用於包裝成品的所有包材清單
c)detailed packaging operations such as filling, closing, labelling, and coding.詳細的包裝操作：諸如填充，封箱，標識和噴碼。
7.3.2 Start-up checks 生產之前的檢查
Before starting any packaging operation, it should be ensured that:在開始包裝前要確保：
a)the area has been cleared of materials to avoid mixing with materials from previous operations; 上一個操作完畢後要對所在區域進行清線以避免混用。
b)all documentation relevant to the packaging operations, is available;有關包裝的相關文件是可獲得
c)all packaging materials are available;所有包裝材料到位
d)suitable equipment is available for use, in working order, cleaned and, if necessary, sanitized;使用了適合的設備，對要用到的設備進行清洗必要時進行了消毒
e)any coding to permit identification of the product is defined.要確定任何產品的識別碼無誤。
7.3.3 Assignment of batch number 批號的確定
7.3.3.1 A batch number should be assigned to each unit of finished product.每組成品的批號要被確定
7.3.3.2 This number does not need to be identical with the batch number that appears on the label of the bulk product, but, if not, it should be easy to relate to that number. 每個產品要有批號，雖然並不需要和散裝產品上的批號完全相同，但應當與散裝產品的批號相關聯。
7.3.4 Packaging line identification 包裝生產線識別
At all times, it should be possible to identify the packaging line with its name or identifying code, the name or identifying code of the finished product and the batch number.在任何時候，可通過包裝生產線的名稱或識別碼，成品名稱、識別碼或批號。
7.3.5 Checks of on-line control equipment 在線監控設備的檢查
If used, on-line control equipment should be regularly checked according to a defined programme.如果使用這樣的設備，應根據相關文件對這些設備進行定期檢查
7.3.6 In-process control 過程控制
7.3.6.1 In-process controls and their acceptance criteria should be defined.制定過程控制的可接受準則
7.3.6.2 In-process controls should be performed according to a defined programme.過程控制要按確定的程序進行
7.3.6.3 Any result that is outside the acceptance criteria should be reported and appropriately investigated.報告超出準則的結果並分析
7.3.7 Re-stocking of packaging materials 包材再儲存
If packaging materials remain unused after packaging operations and are intended and deemed acceptable to return to stock, their containers should be closed and properly identified.包裝剩下的包材返還到倉庫時要被標識，並且盛裝的容器要被封口和標識。
7.3.8 Identification and handling of work-in-process 在制品的標識和處理
Filling and labelling is usually a continuous process. Where this is not the case, special measures including segregation and identification should be applied so that no mix-ups or mislabelling can occur.填充和貼標通常是一個連續的過程。如果不是，應使用特定的措施諸如阻隔和標識，以避免混貼和漏貼
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