【正文】 麗珠集團麗珠制藥廠遷建項目 二 期 Document 碼 ： CLP PS0103001 Cleaning Validation Protocol For Filling System Of Lyophilized Powder For Injection(hormone) Production Line 激素類藥 凍干 粉針生產(chǎn) 線 灌裝系統(tǒng) 清潔驗 證 方案 Page 1 of 41 清潔驗證方案 CLEANING VALIDATION PROTOCOL 設(shè)備名稱 Equipment Name 灌裝系統(tǒng) Filling System 清洗 SOP 編碼 Cleaning SOP ID SOPPS0103001 生產(chǎn)線 Production Line 激素凍干粉針生產(chǎn)線 Lyophilized Powder for Injection(hormone) Production Line 建筑樓 Building No P10 Livzon Pharmaceutical Factory Phase two Relocation Project 麗珠集團麗珠制藥廠遷建項目 二 期 Document 碼 ： CLP PS0103001 Cleaning Validation Protocol For Filling System Of Lyophilized Powder For Injection(hormone) Production Line 激素類藥 凍干 粉針生產(chǎn) 線 灌裝系統(tǒng) 清潔驗 證 方案 Page 2 of 41 Prepared by 起草 Title 職務(wù) Name 姓名 Signature 簽字 Date 日期 生產(chǎn) Production 劉麗平 質(zhì)量 控制 QC 楊雯 Reviewed by 審核 Title 職務(wù) Name 姓名 Signature 簽字 Date 日期 生產(chǎn) Production 周蓓 質(zhì)量 控制 QC 劉玉輝 驗證 Validation 黎維尚 質(zhì)量 保證 QA 付小蓉 Approved by 批準 Title 職務(wù) Name 姓名 Signature 簽字 Date 日期 質(zhì)量受權(quán)人 QP 王銳 Livzon Pharmaceutical Factory Phase two Relocation Project 麗珠集團麗珠制藥廠遷建項目 二 期 Document 碼 ： CLP PS0103001 Cleaning Validation Protocol For Filling System Of Lyophilized Powder For Injection(hormone) Production Line 激素類藥 凍干 粉針生產(chǎn) 線 灌裝系統(tǒng) 清潔驗 證 方案 Page 3 of 41 Revision History 修訂歷史紀錄 Revision 版本 Date of Version 修訂日期 Description of Change 變更描述 Revised By 修訂人 01 2020 年 5 月 19 日 新制定 劉麗平 Livzon Pharmaceutical Factory Phase two Relocation Project 麗珠集團麗珠制藥廠遷建項目 二 期 Document 碼 ： CLP PS0103001 Cleaning Validation Protocol For Filling System Of Lyophilized Powder For Injection(hormone) Production Line 激素類藥 凍干 粉針生產(chǎn) 線 灌裝系統(tǒng) 清潔驗 證 方案 Page 4 of 41 TABLE OF CONTENTS 目錄 1. INTRODUCTION 引言 ...................................................................................................................................... 6 SUMMARIZE 概述 ............................................................................................................................................ 6 SCOPE 范圍 .................................................................................................................................................... 6 2. PURPOSE驗證目的 ........................................................................................................................................... 6 ............................................................................................................................ 6 4. APPLICABLE REGULATIONS AND CODES REFERRED 適用的法規(guī)和指南 ................................... 7 5. ABBREVIATION AND DEFINITION 縮寫與定義 ...................................................................................... 8 6. CHANGE CONTROL 變更控制 ...................................................................................................................... 8 7. RELEVANT DOCUMENT相關(guān)文件 .............................................................................................................. 8 8. PEREXECUTION SIGNATURE LIST/TRAINING VERIFICATION 方案實施前簽名表 /培訓(xùn)確認..................................................................................................................................................................................... 9 9. SYSTEM DESCRIPTION 系統(tǒng)描述 ................................................................................................................ 9 10. PRODUCT GROUP DESCRIPTION 產(chǎn)品描述 ........................................................................................10 11. CLEANING AND STERILIZATION PROCEDURE 清洗滅菌規(guī)程 .....................................................10 PROCEDURE 取樣程序 ..........................................................................................................10 SWAB SAMPLING 擦拭取樣 .......................................................................................................................10 RINSE SAMPLING淋洗水取樣 ..................................................................................................................13 SAMPLING PLAN取 樣計劃 ........................................................................................................................14 RESULT CONNECTION 數(shù)據(jù)收集 ................................................................................................................15 13. ACCEPTANCE CRITERIA接受標準 .........................................................................................................15 VISIBLE RESIDUE 可見殘留物 ...................................................................................................................15 SWAB ACCEPTANCE CRITERIA 擦拭取樣限度 ..........................................................................................15 RINSE WATER淋洗水 .................................................................................................................................20 PROCEDURE 檢測程序 ..............................................................................................................20 TOC 限度計算 ...........................................................................................................................................20 驗證內(nèi)容 ....................................................................................................................................................21 樣品測定 ....................................................................................................................................................22 15. DEVIATION LOG 偏差記錄 .........................................................................................................................22 16. DEVIATION REPORT偏差報告 ..................................................