【正文】 obial 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(yàn)證方案 編號(hào)： 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。 10mg規(guī)格每批生產(chǎn)結(jié)束后 ，對(duì)所有在 生產(chǎn)中 使用 的 生產(chǎn) 設(shè)備及容器具進(jìn)行清潔，清潔后取樣檢測(cè)化 學(xué)殘留及微生物殘留，要求殘留量低于設(shè)定的殘留限度要求。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 。XXXX藥業(yè)驗(yàn)證文件 編號(hào)： 頁碼： 1/50 Validation Document of XXXX pany No.: Page: 1/50 XXXX片（ 10mg 規(guī)格） 清潔 驗(yàn)證 方案 Cleaning Validation Protocol of XXXX Tablets(10mg) 方案起草 Prepared by 部門 /崗位 Dept./Position 簽名 Signature 起草日期 Date QA 年 (Y) 月 (M) 日 (D) 方案審核 Reviewed by 部門 /崗位 Dept./Position 簽名 Signature 審核日期 Date QC主管 QC Supervisor 年 (Y) 月 (M) 日 (D) QA主管 QA Supervisor 年 (Y) 月 (M) 日 (D) 方案批準(zhǔn) Approved by 部門 /崗位 Dept./Position 簽名 Signature 批準(zhǔn)日期 Date 質(zhì)量 保證 部經(jīng)理 QA Manager 年 (Y) 月 (M) 日 (D) 頒發(fā)部門 Issued by QA 生效日期： Effective Date 分發(fā)部門 Distributed to 制造部（ 1份）、 QC（ 1份） Production Dept.(1 copy), QC (1 copy) 制作備份： 2份 Copies prepared:2 pcs 題目： XXXX片（ 10mg規(guī)格）清潔驗(yàn)證方案 編號(hào)： 頁碼： 2/50 Cleaning Validation Protocol of XXXX Tablets(10mg) No.: Page:2/50 目 錄 Table of Contents /Team Member List............................................................................ 3 /General Introduction......................................................................................................... 4 /Equipments used in the manufacturing .............................. 4 ......................................................................................... 4 used in the manufacturing .................................................................................. 4 ............................................................................. 5 materials contacting with drug product....................................................... 5 /Purpose of cleaning validation ......................................................................... 5 /Responsibility ................................................................................................................... 6 /Production Dept. ................................................................................................. 6 /QA Dept. ..................................................................................................... 6 /Engineering Dept. ....................................................................................... 7 /Execution of protocol ........................................................................................... 8 /Filling of Raw Data ................................................................................ 8 、 OOS/OOT的調(diào) /Deviation, OOS/OOT investigation ......................................... 8 /Change Control........................................................................... 8 Content of cleaning validation.......................................................................... 9 Preparation before cleaning validation ....................................... 9 /Criteria of residual limit ................................................ 12 /Sampling procedure and method .............................................. 13 /The process of cleaning validation ....................................................... 16 ................................................... 17 Identification of Personnel Executing this Protocol ...................................................... 17 Attachments and index ....................................................................................... 18 8. 培訓(xùn)記錄 /Training Records .................................................................................................. 19 附件一 制造部及 QC本次清潔確認(rèn)過程中所有使用的設(shè)備、儀器、儀表、計(jì)量器具等確認(rèn)或校驗(yàn)情況總結(jié)表 ............................................................................. 21 Attachment 1: list of verification for production equipments amp。 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(cè)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(cè)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(cè)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(cè)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(yàn)證方案 編號(hào)： 頁碼： 3/50 Cleaning Validation Protocol of XXXX Tablets(10mg) No.: Page:3/50 驗(yàn)證 小組人員名單 /Team Member List 組 長(zhǎng) 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(dòng)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