1、. 培养基适用性检查验证方案 文件编号：VMP-VV-501-00 起 草 人： 审 核 人： 批 准 人： 批准日期： 年 月 日.验证立项申请表 申请部门质量部申请日期 年 月 日验证对象培养基要求完成日期 年 月 日验证原因微生物验证验证类别微生物验证为了确认所采用细菌、霉菌及酵母菌计数和控制菌检查的培养基是否符合微生物限度检查法的规定要求，以保证检验结果的准确、可靠及检验方法的完整性。 申请部门负责人签名： 日期：质量部意见 签名： 日期：验证方案编号VMP-VV-501-00验证报告编号VMP-VV-501REP-00负责人意见 签名： 日期：验证小组成员部门姓名职务备注：验证方案审
2、批表审批程序部门负责人签名日期备注起草 审核批准负责人备注1.概述 通过验证以确认所采用的培养基适合于细菌、霉菌及酵母菌的测定及控制菌的检查，根据特性制订检验方法和检验条件，按制定的方法进行试验，根据验证结果判断是否符合验证标准。若符合，按验证的方法和条件进行微生物限度检查；若不符合，重新建立制订检验方法和检验条件，再进行验证，直至验证结果符合设立的验证标准。2.验证目的及范围为了确认所采用细菌、霉菌及酵母菌计数和控制菌检查的培养基是否符合微生物限度检查法的规定要求，以保证检验结果的准确、可靠及检验方法的完整性。3.验证风险评估对于本次验证的执行进行了如下的风险分析：严重程度 S可能性 P可检
3、测 D风险优先级 RPN = SPD1低1低1高RPN7低可以接受，无需采取措施2中2中2中16RPN8中一定程度上接受，但应按风险优先级采取措施尽可能降低3高3高3低RPN16或严重程度4高不能接受，尽快采取措施降低4关键4极高4极低步骤/单元危害S可能原因/程序失败P现行控制DRPN需采取措施SPDRPN培训验证部分项目出现偏差或漂移3方案培训不到位，方案的执行者不熟悉方案内容2严格执行经批准的验证报告进行培训，并考核合格318确认按照批准的方案培训，培训者均熟练掌握所培训内容。1122检验过程操作不当未达到设定标准，验证失败。3未遵循培养基适用性检查检查操作规程，未严格遵循方案规定方法。
4、2制定培养基适用性检查检查操作规程，并对规程及设立的验证方法培训，按规程及方案要求进行操作。318确认培养基适用性检查检查操作规程已制定并批准，确认人员已培训；确认操作规程适用性。11224.验证前准备4.1验证人员培训：验证报告起草人有责任在方案批准后（且在验证实施前）对本次验证相关人员进行培训。培训人员记录见附件1。4.2将所有的平皿和稀释剂都应该严格按照相关的灭菌程序消毒，以确保其对试验的结果没有影响。4.3仪器与器具：恒温培养箱、生化培养箱、高压蒸汽灭菌器、净化工作台、无菌培养皿、无菌移液管。 5.验证内容5.1测试环境条件要求所有检查在环境洁净度C级下的局部A级洁净度的单向流空气区域
5、内隔离系统内进行，其全过程严格遵守无菌操作，能防止微生物污染。5.2计数培养基5.2.1验证用菌种及培养基：5.2.1.1来源： 食品药品检验所 5.2.1.2菌落计数用菌种菌种名称内控编号大肠埃希菌(Escherichia coli) CMCC（B）44 102E-金黄色葡萄球菌(Staphylococcus aureus) CMCC（B）26 003S-枯草芽孢杆菌(Bacillus subtilis) CMCC（B）63 501B-白色念珠菌(Candida albicans) CMCC (F) 98 001 C-黑曲霉(Aspergillus niger)CMCC(F) 98 003A
6、-注：编号由菌种首字母-传代代数-配制日期组成。5.2.2培养基及其制备方法：取市售的脱水培养基，分别按照规定方法进行配制后灌装于洁净的三角烧瓶中，然后加塞灭菌，在实验前加温熔化备用。培养基名称培养基批号配制日期有效期至营养琼脂培养基玫瑰红钠琼脂培养基营养琼脂对照培养基玫瑰红钠琼脂对照培养基5.2.3菌液制备5.2.3.1接种金黄色葡萄球菌、大肠埃希菌、枯草芽孢杆菌的新鲜培养物至10ml营养肉汤培养基中，3035培养1824小时，取此培养液1ml，加0.9无菌氯化钠溶液至10ml，采用10倍递增稀释法，稀释至10-610-7，使菌数约为50100cfu/ml，做活菌计数备用。5.2.3.2接种
7、白色念珠菌的新鲜培养物至10ml改良马丁培养基中，2328培养2448小时，取此培养液1ml，加0.9无菌氯化钠溶液至10ml，采用10倍递增稀释法，稀释至10-610-7，使菌数约为50100cfu/ml，做活菌计数备用。5.2.3.3接种黑曲霉的新鲜培养物至改良马丁琼脂斜面培养基上，2328培养57天的用35ml 含0.05%（ml/ml）聚山梨酯80的0.9%无菌氯化钠溶液，将孢子洗脱。然后，吸出孢子悬液（用管口带有薄的无菌棉花或纱布能过滤丝的无菌毛细吸管）至无菌试管中，取1ml加含0.05%（ml/ml）聚山梨酯80的0.9%无菌氯化钠溶液至10ml，采用10倍递增稀释法，稀释至10-
8、410-6,制成每1ml含孢子数50100cfu的孢子悬液备用。5.2.4验证方法：5.2.4.1试验组：取大肠埃希菌、金黄色葡萄球菌、枯草芽孢杆菌各1ml，分别注入无菌平皿中，立刻倾注营养琼脂培养基，每株试验菌平行制备2个平皿，混匀，凝固，置3035培养48小时，计数、观察菌落情况；取白色念珠菌、黑曲霉各1ml，分别注入无菌平皿中，立刻倾注玫瑰红钠琼脂培养基，每株试验菌平行制备2个平皿，混匀，凝固，置2328培养72小时，计数、观察菌落情况。测定结果见附件2。5.2.4.2对照组：取大肠埃希菌、金黄色葡萄球菌、枯草芽孢杆菌各1ml，分别注入无菌平皿中，立刻倾注营养琼脂对照培养基，每株试验菌平
9、行制备2个平皿，混匀，凝固，置3035培养48小时，计数、观察菌落情况；取白色念珠菌、黑曲霉各1ml，分别注入无菌平皿中，立刻倾注玫瑰红钠琼脂对照培养基，每株试验菌平行制备2个平皿，混匀，凝固，置2328培养72小时，计数、观察菌落情况。测定结果见附件2。5.2.4.3菌回收率计算： ;Jt*试验组的菌回收率（%）=（试验组平均菌落数/ 对照组平均菌落数）100% h12 5.2.5判定标准：菌回收率均应不低于70%，且菌落形态大小与对照培养基上的菌落一致。5.2.6结论：对计数培养基适用性检查的验证结果进行评价和总结。5.3控制菌培养基适用性检查：5.3.1验证用菌种：5.3.1.1来源：
10、食品药品检验所 5.3.1.2验证用菌种菌种名称内控编号大肠埃希菌(Escherichia coli) CMCC（B）44 102E-金黄色葡萄球菌(Staphylococcus aureus) CMCC（B）26 003S-5.3.1.3培养基及其制备方法：取市售的脱水培养基，分别按照规定的方法进行配制后灌装于洁净的三角烧瓶中，然后加塞灭菌。在实验前加温熔化备用。培养基名称培养基批号配制日期有效期至胆盐乳糖培养基MUG培养基乳糖胆盐发酵培养基胆盐乳糖对照培养基MUG对照培养基乳糖胆盐发酵对照培养基5.3.2菌液制备：接种大肠埃希菌、金黄色葡萄球菌的新鲜培养物至10ml营养肉汤培养基中，303
11、5培养1824小时，取此培养液1ml加0.9无菌氯化钠溶液至10ml，采用10倍递增稀释法，稀释至10-410-6，使细菌数约为5001000cfu/ml。5.3.3验证方法：5.3.3.1促生长能力培养基：取大肠埃希菌各0.1ml，分别涂布于胆盐乳糖培养基、MUG培养基和乳糖胆盐发酵培养基及其对照培养基上，在3035培养18小时，观察菌落情况。测定结果见附件3。5.3.3.2抑制能力培养基：取金黄色葡萄球菌各0.2ml，分别涂布于胆盐乳糖培养基和乳糖胆盐发酵培养基及其对照培养基上，在3035培养18小时，观察菌落情况。测定结果见附件3。5.3.3.3指示能力培养基：取大肠埃希菌各0.2ml，
12、分别涂布于乳糖胆盐发酵培养基及其对照培养基上，在3035培养18小时，观察菌落情况。测定结果见附件3。5.3.4判定标准：5.3.4.1促生长能力培养基：试验培养基与对照培养基生长的菌落大小、形态特征应一致。5.3.4.2抑制能力培养基：试验菌均不得生长。5.3.4.3指示能力培养基：试验培养基与对照培养基生长的菌落大小、形态特征、指示剂反应情况等应一致。5.3.5结论：对控制菌培养基适用性检查的验证结果进行评价和总结。6. 变更和偏差处理： 验证过程中如果出现偏差和变更，应立即通知验小组对偏差和变更进行详细记录，分析偏差产生的根本原因并提出解决方法。所有偏差和变更得到有效处理后，验证方可进入
13、下一步骤。偏差处理单和变更单经过批准后其原件必须附在验证报告中。见附件4。7. 验证结果评定及结论： 质量部负责收集各项验证试验结果，起草验证报告，报验证委员会。 验证委员会负责对验证结果进行综合评审，做出验证结论，发放验证证书，确认培养基适用性检查情况。见附件5。8.拟定再验证周期： 验证小组根据验证情况，拟定再验证周期，报验证领导小组审批。9.会审及批准 会 审： 批 准：附件1培训人员记录表部 门培训人员签名签到日期培训师签名日 期附件2 营养琼脂计数培养基 结果试验菌营养琼脂营养琼脂对照回收率菌落观察情况菌落数菌落数大肠埃希菌1122平均平均金黄色葡萄球菌1122平均平均枯草芽孢杆菌1
14、122平均平均 结果试验菌玫瑰红钠琼脂玫瑰红钠琼脂对照回收率菌落观察情况菌落数菌落数白色念珠菌1122平均平均黑曲霉1122平均平均验证结果评定操作人日期复核人日期附件3 控制菌检查用培养基 项目结果促生长能力抑制能力指示能力胆盐乳糖培养基胆盐乳糖对照培养基MUG培养基MUG对照培养基乳糖胆盐发酵培养基乳糖胆盐发酵对照培养基验证结果评定操作人日期复核人日期附件4偏差处理与变更记录验证项目名称验证项目编号偏差说明：可能的原因：偏差分类：重大 小理由：采取措施：（如需要另附文件）结果：（如需要另附文件）建议（如需要另附文件） 接受偏差 不接受偏差理由：（如需要另附文件）批准人： 日期：附件5 验证
15、证书根据药品生产质量管理规范（2010年版）要求，对 验证。经本公司有关部门进行验证审查，结果符合验证要求，批准使用。特发此证。验证项目名称： 验证方案编码： 验证完成日期： 有 效 期： 1培养基适用性检查应在当前验证条件下使用，使用条件发生变更，应报验证领导小组审核，必要时重新验证。2培养基适用性检查应按批准的标准检验和验证。批准人：年 月 日 备 注：1设备（公用系统）、工艺应在当前验证条件下使用，使用条件发生变更，应报验证领导小组审核，必要时重新验证。2设备（公用系统）应按批准的标准使用、维护保养程序进行操作、维护和保养。 .新标准大学英语视听说教程2习题答案及听力原文Unit 1.I
16、nside view2. They have decided on: 2, 5 and 55,1, c; 2.C; 3.b; 4. A; 5.d6.1.Maybe I should2. Supposing 3. everythings organized, isnt it4. Ive arranged for people to5. Ill count it all up6. Wed better7. Ive got a suggestion8. How aboutOutside view2.The true statements are 3 and 53.1, one of the best
17、 universities2. most talented students 3. well-known around the world4. have open doors5. good social life6.you want it to be7. on another campus8. its a fun place9. go to concerts10. during the weekListening in8.1. b; 2. D; 3.D; 4.B ; 5, aUnit 2Inside view 2. Kate; Kate; Janet; Janet; Janet; Janet;
18、 Kate34-1-2-7-3-5-66.1. b; 2, a; 3. D; 4, d; 5. D;7.1. She was feeling2. I felt as if3. I wouldnt worry about it4. I wish I could have helped5. you look cheerful6. What an amazing grade7. I feel on the top of the world8.1. a; 2. A; 3.A ; 4. A; 5.A; 6. BOutside view2. 1. Kim2. Kim3. Ted4. Sebastien5.
19、Ted6. Kim7.Sebastien8. Kim3.The true statements are: 2, 3 and 54.1. c; 2. A; 3.B; 4.C; 5.D; 6.A; 7.D; 8.B ; 9. C; 10. AListening-in1. Red2. Blue3. Blue-green4. Green5. Red6. Green7. Red8. Red9. Blue10. Orange11. Blue12. Yellow-green13. Blue14. Orange15. Yellow16. Yellow-orange4.1. blue; 2. Yellow; 3
20、, green; 4.Blue-green; 5.Red; 6.Orange; 7.Blue-green; 8. Yellow7.1.g; 2. F; 3.D; 4.C; 5.E; 6. B; 7, aUnit 3.Inside view4.1. c; 2. D; 3.B; 4.d 5. B5.1. This woman said that.2. Youre joking3. Thats what she said4. Its just too much5.She thinks6. Im really furious.7. Unbelievable8. what they said was6.
21、1.a; 2, b; 3. B; 4. B. 5. A. 6. AOutside view.3.1. gain access2. commit this crime; looking at property; an uncut garden3. 800 crimes4. white female(African and Asian Britons are more likely to live in larger family units.)4,6-4-2-5-1-35.1. b; 2. D; 3.B; 4. B. 5. DListening-in3. 1. the policeman2. b
22、ite someone3. 2,0004. the newspaper5. what was happening6.1. Anna Black2. Just over a week ago3. about seven4. male5. mobile phone6. two men7. five minutes7.1. b; 2. A; 3.A; 4.B; 5. DUnit 4.Inside view1.1. story A, 32. story B, 13. story B, 34. story A, 25. story A, 16. Story B, 22,1.front2.several3
23、. did not realize4. the thief5. sell3,1. Mark2. Mark3. Mark4. Janet5. Kate6. Mark, Kate4,1. Tornadoes have damaged home in Northern England2. He is still missing3. Global warming is accelerating4. There are lots of different views and it I very stimulating5. A news addict6. They have to be knowledge
24、able about current affairs7. Whether she is going to watch Friends with her later.5,1. There is still no news of 2. Scientists claim that3. Mostly get my news4. Ive got used to 5. Ive got into the habit of6. I spend too much time6.1.b; 2. A; 3.B; 4.B; 5.B; 6. AOutside view2,2-7-4-5-1-3-63,1.do you m
25、ind2. journalism, photography3. for two hours4. getting these invitations5. on the screen4.The true statements are; 2 and 55.1. Every Saturday night2. To take peoples pictures3. How do you like the idea that someone can take pictures of you on the street?4. They feel you shouldnt have the right to i
26、nvade their privacy.5. Because whatever were consuming, were encouraging them to spread(by buying magazines with such photos in them we are encouraging paparazzi to go and take such pictures.)Listening-in2.1. He says he was on the phone to his girlfriend, but in the cartoon he was actually talking t
27、o a girl in the kitchen.2. Because he is the person being interviewed for the news story and knows the most about it.3.1. Phil Taylor2. South Block, Room 183. November 104. 11 pm5. He had a telephone conversation with his girlfriend and forgot about the chips he was deep-frying, and then the chips a
28、nd oil caught fire.6.ten minutes7. The fire ruined the cooker, two kitchen units and one wall.4.1. d; 2. A; 3.A; 4.B; 5. C7.1. Tricia2. Karen3. Tricia4. Karen5. Karen6. Rick7. Tricia, Rick and Karen8.1. just as many2. how they behave3. a gardening programme4. do very well5. to say to thatUnit 5Insid
29、e view1.Topics mentioned are：2,3,5,6 and 821. Id love to know more about the emperor，he was cool。2. Before that，there were seven big stars and they had been fighting each other for many years.3. Qin was king of the largest state and he defeated the six other states, one after another.4. After his ar
30、my had attacked the first state, the next state surrendered without much fight.5. The army leaders were very clever, they used a river to flood the city.6. After conquering the last state, Qin made himself Emperor of the whole of China.7. Was he the emperor who created the Terracotta Warriors?8. He
31、was so afraid of death that he wanted them to guard him in the afterlife.3.1. Something like 500,000men.2. He is seen as the greatest emperor in Chinese history.3. Yes, of course he had enemies.4. Yes, he built the first Great Wall。4.1. She says it was an incredible achievement.2. As a result of uni
32、fication.3. He standardized writing, the money system and the system for measuring and weighing things.4. He built it to stop tribes from the north invading.5.1. Well, so he unified China2. as a result3. something like4. as a result5. Some people hated him so much 6. so he built a huge wall.6.1. b;
33、2. A; 3.B; 4. AOutside View2. 3-6-5-7-2-1-43.1.dawn service2. remember; forget3. died in battle; identified4. one unshakable truth5. conflicts; around the world6. remembering; go home4.1. a; 2. C; 3.B; 4.A; 5.D; 6.A; 7.D; 8.C; 9.C; 10. BListening-in 2.1. businessman; 11 years old2. first name; his s
34、econd name3. the same age as4. terrible four years; survive5. his Japanese friend6. strength; courage31. B; 2. D; 3.A; 4. D. 5. B5.1. Women in the Land Army worked in agriculture as the men were away fighting2. No, they were in non-combatant roles, although some of them flew transport planes and oth
35、ers worked in dangerous places, like fighter stations.3. They worked in transport, catering, tracking bombers and generally in support services.6.1. It was very hard work, very physical.2. She thought planes were exciting and she liked the uniforms.3. She worked on a fighter station tracking the German bomber.4. They were always in danger of being bombed.5.They had contributed so much to the war effort and to society, therefore, their role in society should be highly valued.Unit 6.Inside view
