固體車間清潔驗(yàn)證預(yù)案

1、上海金冀商務(wù)咨詢有限公司,Shan ghai Jinji Busin ess Con suit ingCo., Ltd文件編號(hào):固體車間清潔驗(yàn)證方案Clea ning validati on Master Pla n forSolid Dosage WorkshopAssurance立項(xiàng)部門： 質(zhì)量保證部Initiation Department: QualityDepartment工藝驗(yàn)證小組負(fù)責(zé)人：Leader of validation teem:方案制訂日期： 年 月Date: Year Month Day目錄List of Content一. 驗(yàn)證概述OVERVIEW OF VALI

2、DATION二. 驗(yàn)證組織機(jī)構(gòu)及人員安排VALIDATION ORGANIZAGION AND MEMBERS三. 應(yīng)用范圍AREAS OF APPLICATION四. 風(fēng)險(xiǎn)評(píng)估RISK EVALUATION五 驗(yàn)證方案表格VALIDATION MATRIX六 清潔溶劑CLEANSING AGENTS七. 可同意標(biāo)準(zhǔn)的確定ACCEPTANCE CRITERIA八. 清潔驗(yàn)證取樣CLEANING VALIATION AND SAMPLING九清潔驗(yàn)證的實(shí)施IMPLEMENTATION OF CLEANING VALIDATION十 . 偏差、變更DEVIATIONS AND CHANGES十一

3、. 再驗(yàn)證RE-VALIDATION驗(yàn)證概述 Overview of Validation 1. 驗(yàn)證目的依照GMP的要求，在口服固體制劑生產(chǎn)結(jié)束后，要對(duì)生產(chǎn)設(shè)備及操作間進(jìn)行完全清潔，以幸免造成不同批號(hào)或不同品種產(chǎn)品之間的污染和交叉污染。依照各生產(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，進(jìn)行風(fēng)險(xiǎn)分析，選出最壞情況產(chǎn)品。為了驗(yàn)證清潔方法的穩(wěn)定性與可靠性，對(duì)所選的最壞產(chǎn)品進(jìn)行三次清潔驗(yàn)證。每批產(chǎn)品生產(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。According to requirements of GMP,the m

4、anufacturing equipments and rooms must be completely cleaned to avoid contamination of different batches of same products or cross-contamination of different products after manufacturing of oral solid dosage.There are two types of cleaning method based on SOPs ofOperation/ Cleaning and maintenance f

5、or individual equipments: implement the risk analysis assessment to choose the worst case products. Three consecutive cleaning validation will be conducted to validate the stabilityand reliabilityofcleaning method. All equipments and utensils used in manufacturing must be completely cleaned once eve

6、ry batch of the worst case products are finished, then sample to test chemical residual and microbial residual, the requirement is the level of residual is less than the limit of residual.二 . 驗(yàn)證組織機(jī)構(gòu)及人員安排Validation Organization and TeamMembers2.1 制造部 /Production Dept.組織清潔驗(yàn)證方案及報(bào)告的起草；Prepare the cleaning validation protocol/report確定設(shè)備表面積、清潔方法、取樣部位；Determine the surface area of equipments, cleaning sampling locations制定清潔操作規(guī)程；Establish cleaning procedure按清潔操作規(guī)程清潔設(shè)備和容器具；Clean equipments and utensils according to cleaning 確保清潔記錄填寫完整；Make sure the completeness of cleaning records將完成的清