設備清潔驗證方案.doc

松澤化妝品驗證管理程序文件編號：SZ-Q-XXXX修訂日期: 2010-08-17版本：A頁號： 2 of 8 PROCEDURES/INSTRUCTIONS設備清潔驗證方案Equipments Cleaning Qualification Protocol文件編號Doc. No.: 文件版本Revision: 修訂日期Revision Date: 擬案單位Issued by: 編輯Author審核Approved by校對Reviewed by日期Effective Date1. 概述DescriptionDermasil OTC 產品生產設備組由真空乳化攪拌鍋組和液體自動填充機組成。主材采用不銹鋼，易清洗，耐消毒。造型美觀大方，各系統(tǒng)轉動靈活、平穩(wěn)，溫度調節(jié)靈敏、易控制。該組設備主要生產活性成分相同的護膚產品。微生物控制尤為重要。Manufacturing equipment for Dermasil OTC skincare product includes vacuum emulsification mix tank group & Liquid Automatic Filling Machine. These equipments adopt stainless steel materials, and facilitate cleaning and resist disinfection. They are easy to control and have good design, flexible and stable system, sensitive temperature adjusting. These equipments are used to produce skin care products with same active ingredients. Control the microorganism is significant. 2. 目的Purpose檢查并確認OTC生產設備清潔規(guī)程制定是否具有可操作性和科學性，保證清洗后的設備能夠滿足工藝要求。This is to check and verify if these equipments for OTC products are scientific and designed to facilitate operation. 3. 范圍Scope3.1. 本驗證方案主要適用于以下Dermasil OTC護膚產品生產設備的清潔驗證。This protocol is applied for cleaning qualification of these equipments for Demersil OTC Skincare products; 項目Project標準范圍Limits物理外觀檢測Physical test目測潔凈，干燥，無嗅Clean, dry, no scent殘留物濃度限度Limits of residue目測潔凈無色（說明見5.5）Clean and chromaticity (see section 5.5)微生物限度Microbial test 細菌總數(shù)Total bacteria100CFUmL（淋洗水washing water）細菌總數(shù)Total bacteria50CFU25cm2（棉簽擦拭法cotton sticker wiping）4. 職責Role & Responsibilities4.1. QA manager4.1.1. 負責指派驗證小組組長，負責驗證方案及報告批準，發(fā)放驗證證書，確認再驗證周期。Assign team leader, approve validation protocol and reports, issue validation certificate and decide re-validation frequency.4.2. 驗證小組組長Team leader4.2.1. 即具體驗證項目的主導人，主導和協(xié)調驗證工作，負責方案的起草，記錄數(shù)據的收集以及報告整理。Team leader is the leader of specific qualification projects, lead to and coordinate qualification assignment, draft the protocol and collect the data and records and sort out reports.4.2.2. 負責首次清潔驗證方案的起草，完成報告。并指導驗證實施、培訓及技術移轉。Draft first cleaning validation protocol and complete the reports, and guide the implementation, training and technical transfer of the qualification.4.3. QA4.3.1. 負責驗證數(shù)據及結果的審核，Review of qualification data and results.4.3.2. 負責驗證過程的監(jiān)督和驗證報告的審批。Supervise the qualification and review validation report.4.3.3. 負責驗證文件管理。Manage qualification documents.4.3.4. 負責驗證管理的日常工作，制定驗證計劃及監(jiān)督實施，驗證方案管理，驗證工作的協(xié)調，驗證文件的管理。Develop validation plan and supervise the implementation of validation and manage the documents. 4.4. 實驗室LAB4.4.1. 負責制定清潔后殘留物（產品殘留、微生物、清潔劑等）的檢測方法和殘留限度。Develop inspection methods and limits of residue (products left, microorganism, cleaning agent).4.4.2. 負責制定取樣方法和執(zhí)行取樣，并對清潔驗證的結果進行評價。Establish sampling methods and sample for tests, and evaluate the qualification results.4.4.3. 負責對生產選用清潔劑種類及清潔方法進行指導。Guide the production department to choose cleaning agent and cleaning methods.4.5. 生產部Production4.5.1. 負責制定清潔作業(yè)指導書，執(zhí)行清潔操作以及對操作人員的培訓和考核。Make the procedure for cleaning and conduct cleaning activities and do training for the operators.4.5.2. 配合協(xié)調時間及人員的安排。提供必要的資源。Arrange personnel and adjust time, and provide necessary resources.4.6. 設備部Maintenance4.6.1. 負責設備清潔時，對相關設備的拆卸、安裝提供指導培訓。Do training of de-assembly and installation. 5. 驗證內容Qualifications5.1. 在產品生產結束后，按照作業(yè)指導書進行清潔。Follow the procedure to clean the equipments after production.5.2. 最難清潔部位：Position uneasy to clean設備名稱Equipment編號Number部位Position真空乳化攪拌鍋組vacuum emulsification mix tank group均質頭Homo-mixer液體自動填充機Liquid Automatic Filling Machine下料管output pipe5.3. 可接受的限度范圍標準：Acceptance Limits項目Project標準范圍Limits物理外觀檢測Physical test目測潔凈，干燥，無嗅Clean, dry, no scent殘留物濃度限度Limits of residue目測潔凈無色（說明見5.5）Clean and chromaticity (see section 5.5)微生物限度Microbial test 細菌總數(shù)Total bacteria100CFUmL（淋洗水washing water）細菌總數(shù)Total bacteria50CFU皿5.4. 物理外觀檢查：清洗后用含75%乙醇的藍色或者與產品不同顏色的無紡布（已消毒）擦拭表面后應無任何可見的殘留物痕跡，設備及無紡布表面見本色。Physical inspection: use sterile blue or color different from that of the product cloth with 75% ethanol to wipe their surfaces, no residue is visible。5.5. 殘留物濃度限度：該組設備生產的產品所使用的活性成分均為二甲基硅油。均為無毒原料，安全性高。因此以物理外觀檢測潔凈來代替。必要時送第三方檢測一次殘留物含量Residue concentration limits: active ingredients used include dimethicone, they are highly safe raw materials without toxin. So we use physical check after cleaning is accepted. And if necessary we will send once to 3rd party for checking residue.5.6. 微生物限度檢驗Microorganism examination 5.6.1. 真空乳化攪拌鍋組和液體自動填充機采用淋洗水沖洗方法。在清潔工序完成后，用純化水淋洗均質頭，然后參照WI-006微檢室作業(yè)指導，進行取樣，送微生物實驗室進行檢測。具體檢測方法參照WI-006&WI-008。Vacuum emulsification mix tank group & Liquid Automatic Filling Machine use washing water to clean. After clean the tank and homo-mixer, we use purified water to wash the homo-mixer. Samplings refer to WI-006, and sent to micro lab. Micro test method refers to WI-006&WI-008.5.7. 再驗證周期Re-qualification frequencyQA部門根據驗證結果確定設備再驗證周期 QA to decide the re-qualification frequency after verifying the results.6. 偏差處理Deviation Handling驗證出現(xiàn)偏差的指導原則，參考偏差處理