Cosmetics Good Manufacturing Practice Regulations Article 41
The cosmetics manufacturer, according to the need of every manufacture operation stage, relevant documents and data shall be prepared and available. The documents are:1. Equipment documents.2. Formula for the products3. List of all raw material with the quantities and identified batch numbers.4. Detailed manufacturing process for each stage, including the addition of the raw materials, temperature, speeds, mixing time, sampling, cleaning, necessary sanitizing, transfer of bulk products and other related items.Before starting any manufacturing process mentioned in the preceding paragraph, these items have to be ensure:1. All the relevant documents related to manufacturing and all raw materials are prepared, available and released.2. Equipment is able to use properly and has been through appropriate cleaning and sanitizing.3. Operation area is cleaned to prevent from mixing any materials from the previous manufacturing operations.The identification of the manufacturing operation mentioned in paragraph 1 shall be regulated as follows:1. All raw materials measured and weighted according to the formula, and placed in a labelled, cleaned and suitable container, or directly put into the manufacturing equipment.2. Major equipment, raw material containers, and bulk product containers shall be identified easily at any time.3. The identification on the bulk product container shall include: Name or identification code, batch number and storage condition when such information is critical to assure the quality of the products.Manufacturing process mentioned in the preceding paragraph shall be regulated as follows:1. Establish a manufacturing process control plan includes acceptance criteria and to enforce it.2. To enforce the plan mentioned in the preceding sub-paragraph. Any result does not meet the acceptance criteria shall be and reported and investigated according to the procedure.
中文原文 化粧品優良製造準則第41條
化粧品製造業者，應依各製造作業階段需求，具備下列文件或資料，並得供隨時取得查閱：
一、使用設備文件。
二、產品配方文件。
三、具識別批號及數量之所有原料清單。
四、每一階段之詳細製程文件，其內容包括原料添加、溫度、速度、混合時間、抽樣、清潔、必要之消毒、半成品傳送或其他相關事項。
前項製造，應於事前確認下列事項：
一、備齊製造文件及經放行可供使用之原料。
二、設備已經適當清潔或消毒，並可正常運轉。
三、作業區已完成清理，且無殘留前次製造作業使用之原物料。
第一項製造，其製程中之識別，應符合下列規定：
一、所有原料均依配方量測或稱重後，置入適當標示之乾淨合適容器，或直接置入製造設備。
二、主要設備、原料容器及半成品容器，可隨時辨識之。
三、半成品容器記載有名稱或識別碼、批號，及影響產品品質之關鍵性儲存條件。
前項製程，其管制應符合下列規定：
一、訂定包括允收基準之製程管制計畫，並執行之。
二、執行前款計畫，發現有未符允收基準者，循程序報告，並予調查。
一、使用設備文件。
二、產品配方文件。
三、具識別批號及數量之所有原料清單。
四、每一階段之詳細製程文件，其內容包括原料添加、溫度、速度、混合時間、抽樣、清潔、必要之消毒、半成品傳送或其他相關事項。
前項製造，應於事前確認下列事項：
一、備齊製造文件及經放行可供使用之原料。
二、設備已經適當清潔或消毒，並可正常運轉。
三、作業區已完成清理，且無殘留前次製造作業使用之原物料。
第一項製造，其製程中之識別，應符合下列規定：
一、所有原料均依配方量測或稱重後，置入適當標示之乾淨合適容器，或直接置入製造設備。
二、主要設備、原料容器及半成品容器，可隨時辨識之。
三、半成品容器記載有名稱或識別碼、批號，及影響產品品質之關鍵性儲存條件。
前項製程，其管制應符合下列規定：
一、訂定包括允收基準之製程管制計畫，並執行之。
二、執行前款計畫，發現有未符允收基準者，循程序報告，並予調查。