Cosmetics Good Manufacturing Practice Regulations Article 2
The definition of terms used in this regulation are defined as follows:1. Acceptance criteria: the acceptable amount, range, or other suitable measurement methods according to the test result.2. Auditing: 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.3. Batch: the certain produce amount of raw materials, packaging materials, or products from a single or series of manufacturing process.4. Batch number: The identification of certain batch of products which contains numbers, alphabets, or symbolic combinations.5. Bulk product: any product that is completed the manufacturing process, but without the final packaging process.6. Calibration: Under a certain condition, to establish the operation methods and procedures with the known standard reference values to ensure the result values and material testing values of the measurement equipment or measurement system.7. Control: verification that acceptance criteria are met.8. Change control: To ensure all manufacturing, packaging, process control and storage of the products to meet the defined acceptance criteria. The amendment plan conducted by the internal organizations and responsible units related to good manufacturing practice.9. Cleaning: 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.10. Complaint: external information claiming a product does not meet the defined acceptance criteria.11. Contamination: occurrence of any undesirable matter such as chemical, physical and/or microbiological matter in the product.12. Consumables: materials such as cleaning agents and lubricants that are used up during cleaning, sanitization or maintenance operations.13. Contract acceptor: person, company or external organization to enforce an operation on behalf of another person, company or organization.14. Deviation: 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.15. Finished product: cosmetic product that has undergone all stages of production, including packaging in its final container, for shipment.16. In-process control: 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.17. Internal audit: 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.18. Major equipment: equipment specified in production and laboratory documents, which is considered essential to the process.19. Maintenance: any periodic or unplanned support and verification operations designed to keep premises and equipment in proper working condition.20. Manufacturing operation: set of operations from the weighing of raw materials to the making of the bulk products.21. Out-of-specification: examination, measurement or test result that does not comply with the defined acceptance criteria.22. Packaging operation: all packaging steps including filling and labeling, which a bulk product has to undergo in order to become a finished product.23. Packaging material: any material employed in the packaging of a cosmetic product, excluding any outer packaging used for transportation. 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.24. Plant: location for production of cosmetic products.25. Premises and Facilities: physical location, buildings and supporting structures used to conduct receipt, storage, manufacturing, packaging, control and shipment of product, raw materials and packaging materials.26. Production: manufacturing and packaging operations.27. Quality assurance: all those planned and systematic activities necessary to provide confidence that a product satisfies the defined acceptance criteria.28. Raw material: any substance going into or involved in the manufacturing of a bulk product.29. Recall: decision made by a company to call back a product batch that has been put on the market.30. Reprocessing: re-treatment of all or part of a batch of finished product or a 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.31. Return: sending finished cosmetic products which may or may not present quality defect back to manufacturing premises.32. Sample: one or more representative elements selected from a set to obtain information about that set.33. Sampling: set of operations relating to the taking and preparation of samples.34. Sanitization: operation, used to reduce undesirable micro-organisms on inert contaminated surfaces depending on the objectives set.35. Shipment: set of operations relative to the preparation of an order and its putting in a transport vehicle.36. Waste: any residue of a production operation, transformation or use, any substance, material, product that its holder intends for disposal.
中文原文 化粧品優良製造準則第2條
本準則用詞，定義如下：
一、允收基準：指試驗結果判定為可接受之限量、範圍或其他適當衡量規範。
二、稽核：指為確認品質活動計畫之符合性、實效性及目標達成性，對品質活動及其相關結果之獨立性系統查核。
三、批：指單一或系列製程產出具一致性之特定數量原料、包裝材料或產品。
四、批號：指鑑別特定批之數字、字母或符號組合。
五、半成品：指已完成製造階段，尚未最後包裝之產品。
六、校正：指為確認量測設備或量測系統顯示之數值或材料檢測值，於特定條件下，與已知參考標準值之關係，所建立之作業方式及程序。
七、管制：指查證符合允收基準之行為。
八、變更管制：指為確保所有製造、包裝、管制及儲存之產品符合允收基準，內部組織與權責單位對涉及本準則中一項或多項活動之計劃性變更。
九、清潔：指為確保一定之潔淨度及外觀，搭配使用或調整化學反應、機械作用、溫度及作用時間等方式或條件，分離及消除一般目視可見髒汙。
十、申訴：指外部就產品規格不符合允收基準之反應。
十一、污染：指在產品中出現化學、物理或微生物等之非預期物質。
十二、消耗品：指清潔、消毒或維護作業所使用而消耗減損，包括清潔劑及潤滑劑之材料。
十三、受託者：指受化粧品製造業者委託，執行一項或多項有關本準則活動之機關、自然人、學校、機構、法人或團體。
十四、偏差：指當一項或多項與本準則有關之活動，出現預期、非預期或其他臨時性狀況時，偏離特定要求之情形。
十五、成品：指已完成以最終容器包裝，並可供裝運之化粧品。
十六、製程管制：指為確保產品符合允收基準，於生產過程中，所為之監測及必要之製程調整。
十七、內部稽核：指為確保品質活動計畫之符合性、實效性及目標達成性，由化粧品製造業者指派之勝任人員，執行對品質活動及其相關結果之獨立性系統查核。
十八、主要設備：指載明於生產及實驗室文件內之必要設備。
十九、維護：指為確保廠房設施及設備正常運作所為之定期性或非定期性維持及查證作業。
二十、製造作業：指自原料稱量至製成半成品之過程。
二十一、不符合規格：指檢查、量測或試驗結果未符合允收基準之情形。
二十二、包裝作業：指半成品經充填、分裝及標示等所有包裝步驟成為成品之過程。
二十三、包裝材料：指包裝化粧品之材料，不包括供運輸包裝使用之材料。
包裝材料，依其使用上直接與產品接觸之直接性，分為初級包裝材料或次級包裝材料。
二十四、場所：指化粧品之生產處所。
二十五、廠房設施：指進行產品、原料或包裝材料之接收、儲存、製造、包裝、管制或裝運之實體場所、建築物或其內之附屬場所或裝置。
二十六、生產：指製造及包裝作業。
二十七、品質保證：指為確保產品符合允收基準，所為必要且經規劃之系統性活動。
二十八、原料：指製造半成品所使用之任何物質。
二十九、回收：指化粧品製造業者對產品下架決定，及依其決定就市場流通之特定批產品之收回。
三十、再加工：指對於不符合允收基準之部分或全部特定批號成品或半成品，經由一種或數種處理方式，使其品質符合規定之處理。
三十一、退貨：指將發生及未發生品質瑕疵之化粧品成品送回化粧品製造場所。
三十二、樣品：指為取得產品資訊，自特定產品中選出之一個或多個代表性物件。
三十三、抽樣：指有關採集及製備樣品之作業。
三十四、消毒：指依據預設目標，減少受污染之惰性表面上非預期微生物之作業。
三十五、裝運：指收受訂單後，將成品置於運輸車輛之過程。
三十六、廢棄物：指生產作業、轉換或使用過程中所產生，且為化粧品製造業者棄置之殘餘物質、材料或產品。
一、允收基準：指試驗結果判定為可接受之限量、範圍或其他適當衡量規範。
二、稽核：指為確認品質活動計畫之符合性、實效性及目標達成性，對品質活動及其相關結果之獨立性系統查核。
三、批：指單一或系列製程產出具一致性之特定數量原料、包裝材料或產品。
四、批號：指鑑別特定批之數字、字母或符號組合。
五、半成品：指已完成製造階段，尚未最後包裝之產品。
六、校正：指為確認量測設備或量測系統顯示之數值或材料檢測值，於特定條件下，與已知參考標準值之關係，所建立之作業方式及程序。
七、管制：指查證符合允收基準之行為。
八、變更管制：指為確保所有製造、包裝、管制及儲存之產品符合允收基準，內部組織與權責單位對涉及本準則中一項或多項活動之計劃性變更。
九、清潔：指為確保一定之潔淨度及外觀，搭配使用或調整化學反應、機械作用、溫度及作用時間等方式或條件，分離及消除一般目視可見髒汙。
十、申訴：指外部就產品規格不符合允收基準之反應。
十一、污染：指在產品中出現化學、物理或微生物等之非預期物質。
十二、消耗品：指清潔、消毒或維護作業所使用而消耗減損，包括清潔劑及潤滑劑之材料。
十三、受託者：指受化粧品製造業者委託，執行一項或多項有關本準則活動之機關、自然人、學校、機構、法人或團體。
十四、偏差：指當一項或多項與本準則有關之活動，出現預期、非預期或其他臨時性狀況時，偏離特定要求之情形。
十五、成品：指已完成以最終容器包裝，並可供裝運之化粧品。
十六、製程管制：指為確保產品符合允收基準，於生產過程中，所為之監測及必要之製程調整。
十七、內部稽核：指為確保品質活動計畫之符合性、實效性及目標達成性，由化粧品製造業者指派之勝任人員，執行對品質活動及其相關結果之獨立性系統查核。
十八、主要設備：指載明於生產及實驗室文件內之必要設備。
十九、維護：指為確保廠房設施及設備正常運作所為之定期性或非定期性維持及查證作業。
二十、製造作業：指自原料稱量至製成半成品之過程。
二十一、不符合規格：指檢查、量測或試驗結果未符合允收基準之情形。
二十二、包裝作業：指半成品經充填、分裝及標示等所有包裝步驟成為成品之過程。
二十三、包裝材料：指包裝化粧品之材料，不包括供運輸包裝使用之材料。
包裝材料，依其使用上直接與產品接觸之直接性，分為初級包裝材料或次級包裝材料。
二十四、場所：指化粧品之生產處所。
二十五、廠房設施：指進行產品、原料或包裝材料之接收、儲存、製造、包裝、管制或裝運之實體場所、建築物或其內之附屬場所或裝置。
二十六、生產：指製造及包裝作業。
二十七、品質保證：指為確保產品符合允收基準，所為必要且經規劃之系統性活動。
二十八、原料：指製造半成品所使用之任何物質。
二十九、回收：指化粧品製造業者對產品下架決定，及依其決定就市場流通之特定批產品之收回。
三十、再加工：指對於不符合允收基準之部分或全部特定批號成品或半成品，經由一種或數種處理方式，使其品質符合規定之處理。
三十一、退貨：指將發生及未發生品質瑕疵之化粧品成品送回化粧品製造場所。
三十二、樣品：指為取得產品資訊，自特定產品中選出之一個或多個代表性物件。
三十三、抽樣：指有關採集及製備樣品之作業。
三十四、消毒：指依據預設目標，減少受污染之惰性表面上非預期微生物之作業。
三十五、裝運：指收受訂單後，將成品置於運輸車輛之過程。
三十六、廢棄物：指生產作業、轉換或使用過程中所產生，且為化粧品製造業者棄置之殘餘物質、材料或產品。