【正文】 ： 9/50 Cleaning Validation Protocol of XXXX Tablets(10mg) No.: Page:9/50 驗證 內(nèi)容 Content of cleaning validation 驗證 的準(zhǔn)備工作 Preparation before cleaning validation 驗證 前，所有與清潔 驗證 有關(guān)的儀器、設(shè)備應(yīng)進(jìn)行 過校驗或確認(rèn)。 When the testing results are abnormal, follow the SOP the handling of out of specifications (Doc. No.:XXX) to investigate. 當(dāng)出現(xiàn)操作不符合 SOP要求時，執(zhí)行部門應(yīng)通知 QA，執(zhí)行偏差調(diào)查。 Archive the pleted cleaning validation documentation 質(zhì)量 保證 部經(jīng)理： QA Manager 批準(zhǔn)清潔 驗證 方案、 驗證 報告。 According to requirements of GMP, the manufacturing equipments and rooms must be pletely cleaned to avoid contamination of different batches of same products or crosscontamination of different products after manufacturing of oral solid dosage. There are two types of cleaning method based on SOPs of Operation/ Cleaning and maintenance for individual equipments: Watercleaning method and nonwatercleaning method. The cleaning method for XXX belongs to the former. Three consecutive cleaning validation will be conducted synchronously during process validation of 10mg strength Tablets to validate the stability and reliability of cleaning method on the basis of finishing cleaning verification of trial batch. All equipments and utensils used in manufacturing must be pletely cleaned once every batch of 10mg XXXX Tablets is finished, then sample to test chemical residual and microbial residual, the requirement is the level of residual is less than the limit of residual. Because API is not sieved during dispensing phase and directly put into a bag within a transferring container, only spoon contacting with API will be tested for chemical and microbial items, while other parts are only tested for microbial items. /Equipments used in the manufacturing 列出本產(chǎn)品生產(chǎn)中所使用的所有設(shè)備 List all equipments used in this product. Utensils used in the manufacturing 料倉、中轉(zhuǎn)桶、料鏟 Bin, Transferring container and spoon. 題目： XXXX片（ 10mg規(guī)格）清潔驗證方案 編號： 頁碼： 5/50 Cleaning Validation Protocol of XXXX Tablets(10mg) No.: Page:5/50 Construction materials contacting with drug product 與藥品接觸的部位材質(zhì)為 304或 316L不銹鋼；鑄鐵；玻璃等。根據(jù)各生產(chǎn)設(shè)備的《操作、清潔及維護(hù)保養(yǎng)》標(biāo)準(zhǔn)操作規(guī)程，將 清潔方法 分為水溶性及 非水溶 性兩組， XXX 屬于水溶性組 。 QC instruments ............... 21 附件二：取樣位置示意圖 ................................................................................................. 23 Attachment 2 Schematic diagram for sampling locations ................................................... 23 附件三： QC化學(xué)檢測取樣記錄表 ................................................................................... 24 Attachment 3 Sampling record form for QC chemical testing ............................................ 24 附件四： QC化學(xué)檢測結(jié)果匯總表 ................................................................................... 30 Attachment 4 Summary table for QC chemical testing results ........................................... 30 附件五： QC微生物檢測取樣記錄表 ............................................................................... 36 Attachment 5 Sampling record form for QC Microbial testing........................................... 36 附件六： QC微生物檢測結(jié)果匯總表 ............................................................................... 45 Attachment 6 Summary table for QC microbial testing results........................................... 45 題目： XXXX片（ 10mg規(guī)格）清潔驗證方案 編號： 頁碼： 3/50 Cleaning Validation Protocol of XXXX Tablets(10mg) No.: Page:3/50 驗證 小組人員名單 /Team Member List 組 長 Team Leader 部門 Dept. 崗位 Position 姓名 Name 制造部 Production Dept. 業(yè)務(wù)經(jīng)理 Supervisor 小組成員 Team Member 部門 Dept. 崗位 Position 姓名 Name 設(shè)備動力部 Engineering Dept. 業(yè)務(wù)經(jīng)理 Supervisor 制造部 Production Dept. 工藝質(zhì)量員 Technician 制造部 Production Dept. 生產(chǎn)協(xié)調(diào)員 Production Coordinator 制造部 Production Dept. 工藝質(zhì)量員 Production Coordinator 制造部 Production Dept. 工段長 Team leader 制造部 Production Dept. 技術(shù)員 Technician 制造部 Production Dept. 工段長 Team leader 制造部 Production Dept. 技術(shù)員 Technician 制造部 Production Dept. 工段長 Team leader 制造部 Production Dept. 技術(shù)員 Technician 制造部 Production Dept. 工段長 Team leader 制造部 Production Dept. 技術(shù)員 Technician 制造部 Production Dept. 工段長 Team leader 制造部 Production Dept. 技術(shù)員 Technician QC QC主管 QC Supervisor QC 理化 1組組長 Leader of physicochemical team 1 QC 微生物組組長 Leader of Microbial team QC 微生物檢驗員 Analyzer QA QA檢查員 QA inspector QA QA檢查員 QA inspector QA QA檢查員 QA inspector QA 驗證管理員 Validation administrator 題目： XXXX片（ 10mg規(guī)格）清潔驗證方案 編號： 頁碼： 4/50 Cleaning Validation Protocol of XXXX Tablets(10mg) No.: Page:4/50 /General Introduction 根據(jù) GMP 的要求，在口服固體制劑生產(chǎn)結(jié)束后，要對生產(chǎn)設(shè)備及操作間進(jìn)行徹底清潔，以避免造成不同批號或不同品種產(chǎn)品之間的污染和交叉污染。 因配料階段原料不進(jìn)行篩分，稱重后放入塑料袋內(nèi)再放入中轉(zhuǎn)筒中儲存，所以配料階段 清潔后只對接觸原料的料鏟進(jìn)行化學(xué)及微生物取樣，其它部位只進(jìn)行微生物取樣。 Use those instruments within calibration expired date QA 制定清潔 驗證 計劃及 驗證 編號； Establish cleaning validation plan and No. 負(fù)責(zé)組織審核清潔 驗證 的方案 /報告； Organize the review the cleaning validation protocol/report 組織清潔 驗證 相關(guān)部門進(jìn)行清潔 驗證 方案的培訓(xùn)并記錄； Organize the training and record for cleaning validation protocol 負(fù)責(zé)驗證實施過程的協(xié)調(diào)，保證驗證項目實施進(jìn)度； Coordinate the activities of cleaning validation to ensure the performance. 題目： XXXX片（ 10mg規(guī)格）清潔驗證方案 編號： 頁碼： 7/50 Cleaning Validation Protocol of XXXX Tablets(10mg) No.: Page:7/50 驗證 實施中的監(jiān)控檢查； Supervise the validation activities. 保證經(jīng) 驗證 的參 數(shù)符合預(yù)期的標(biāo)準(zhǔn)； Make sure validated parameters meet predetermined criteria 負(fù)責(zé)組織 驗證 方案中改變控制、偏差處理的調(diào)查； Organize the investigation for the change control and deviation handling. 負(fù)責(zé)將完成的清潔 驗證 文件歸檔。 QA should check the pleteness of data records and make sure whether they are satisfied related requirements. 、 OOS/OOT的調(diào) /Deviation, OOS/OOT investigation 當(dāng)檢測結(jié)果異常時，按照《檢驗結(jié)果超標(biāo)情況的處理》文件編號 XXX的操作規(guī)程執(zhí)行。 When the operations don’t meet the requirements specified in SOPs, the associated dept. should notify QA to make deviation