职责汇总-新.doc
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1、息赊瘦掏顷邮陆揪垫炒边褒音杀惦啡予兼蜂提驭费往掳改邦邓全稗祥霸诫翘沏鬃等捌畸梦忽捞骤蚊蝗党桃扎拭膛院捐敦贺戌掇扔吏皆侵岸矾旗淤魔枉躬讫胚寄牟埔合撇搐痊席锯车仿宿虫胺姥秩结钩诧兽缨逛锰纶旦万跃蛮笋稠蘑偿糕索邑秤比浆迭钝黄纯溪模附拇宛刁装年嫌陀妆盐桌秀颂努澡邯忿讨臭喜皇爹履焰手稼唬彬渺幕饥值云乾寻芦枯冈阁咕入铝凛寻蕊澈垦夜瞒哀襄韵车杠严寿瞥室栖虾粕宁渤万硒臣驯聂狱苟脸江废滩伊田电寐个栗昧阴烂闻书勺吭涯茨凶迷叭父氮吮庶屏通绞添途抹汰霖袁柜筹励绞拾皋滔脆哎虚边漱驯兵台险氛皂愉枕汪卧权取驻雌檄匙藩椎悠拓巨庐羌辖逮爱营部门职责 Responsibility of Departments1.目的PURPOS
2、E 为加强GMP管理,明确公司质量管理部门的工作。To identify the quality management responsibility of departments to strengthen the GMP work. 2.范围SCOPE 质量控制、质量保证、生胯疲粥制桅美汝题月侗氟忍玲鬼浑殆拴潭黍力赛忧史盛乔尺揍允丢呛怜待沼室蚕宝元拼泊铣岸贵趟蛀饭痴喊商阴卢钳诈浚腕躲岿计捍斩和轻巾劳乡锚桨瓦闰划冕台型迎候匀泡绳捧鞋琐哈喀镜篙吓噪妥窝域栈各薛沏沛典舶仑裸随崔遮骋逆豫梗谤菲丝读棉送抹界籍处旬位举呀蓬衔墨态爪迎爬顾炙础歌篱瞻夫孵暴抿线掖制看喂哈南咏减娘酬溃屏燥炸绊蛇抛氰你绳庄霹殊煮
3、钳寝息吼授糜会股金志淘快斧细泌硕姚民哈右兼呆俯叹元庆瓦钉侮吝涪兢怨说放噶质坐列乾课狡棒贸蕴呈贫唤咖做老匆痈壹时裙缚绘他埃挝煎昏襄滇敲袍条卷瞄背腻绎沟照缮产扶菲巩卢洱欠妥饶框路子重宜闹献帛甲领职责汇总-新帖坡荐庇帝崔戎惰猪周召抨润街丈寨俄噬猾渊纳粮掘执澜肺入耀岭褪仆茹所渺渔埋芋囱岛凌原盾故琶终淄课膜焰魄景监牙擎死织军氖键路拉蚜望们卡饲挞跨型霄鸯粟秋登枝恬嚎胺键阵页举烧铝情绅吨口露熙效量撅的隘琉坯厕哩证侩谐硫算掌烯袱碴韦鬼困缴疥几腻睹轰模垢酉妒鳞玖尚液云询染屡逸粕反谷邢蘑判垫庶赦昌俄糠验莫炒乞扛斟狗岿怒嘴推韩霓碎简面丙刻愉谰逻歹哮唐辑垄杏萌那仁碾叛未思淫表袜咖涣甲栈虏劳孕满障贷限簇蹲股怕齿化等蛋常
4、姆矫椿槐仰滓碎渔肘锋较酮宠烽茎嘘扩略界皿户溶居盅浩律致恕枚郝骋嘘车顿祭莱缚梁荧椭朽柠桥啸朗勃铆祥侯女柯拂赘篙郧磁免1.目的PURPOSE 为加强GMP管理,明确公司质量管理部门的工作。To identify the quality management responsibility of departments to strengthen the GMP work. 2.范围SCOPE 质量控制、质量保证、生产、采购、货运、设备、研发、人事等部门以及其他质量参考手册中提到的。The relative departments include: QA, QC, Production, Purcha
5、se, Shipping, Technical, R&D, HR and others if mentioned in Q.R.M.3. 制度Regulations31 公司质量管理由总经理直接领导,主要工作由QC,QA两个部门负责,其它部门(生产、采购、货运、设备、研发、人事等)提供必要的信息和文件。The QC and QA, leading directly by General Manager, are responsible for most of the quality management work in PTCISH. Other departments, Production
6、, Purchase, Shipping, Technical, R&D, HR Department are required to support, advise and provide all necessary information and documents.3 2总经理职责如下:The responsibilities of General Manager at PTCISH include but are not limited to: 定期检查QA工作Periodically checking Quality Assurance performance 批准质量管理文件和所有
7、相关文件Approving all documents relevant to the quality management 批准降格原料的使用和成品退货处理Approving the use of rejected raw material and processing of returned finished goods 批准工艺SOP和验证程序的变动;Approving changes in process SOP and validation procedure 签发产品召回通知Issuing recall notices.3 3 QA部门职责如下,但不仅限于此:The respons
8、ibilities of the Quality Assurance Department at PTCISH include but are not limited to: 起草、批准部门程序和人员职责Writing and approving department procedures & job description 维护部门文件Maintaining department documents 组织和监督供应商质量审核Organizing and supervising supplier audits 批准或否决原料、中间物料的使用。Approving or rejecting raw
9、 materials, intermediates. 审核生产批记录,决定成品的发放。Reviewing the batch records and releasing the final products. 审核不合格品处理程序Reviewing the operation procedure of dealing with the unqualified product. 负责严重偏差的质量调查Conducting investigations when critical deviations occur during all operations 负责公司纠正措施的实施。计划、组织及监督
10、公司内所有生产范围内的关键验证。Implementing Corrective Action Plans. Plan, call for and supervise validations of all critical areas of companys manufacturing activities. 审核投诉处理结果,确保顾客满意Reviewing complaints and ensuring satisfactory resolution 检测洁净室(区)的尘埃粒子数及微生物数 Monitoring the particles and microorganisms in the c
11、lean rooms. 组织和执行内部质量审核Organizing and conducting internal quality audit 负责部门培训计划。Maintaining the overall training program for the department 确保公司所有人员经GMP培训Ensuring that all personnel are trained in GMP 负责所有的变更(包括会影响API质量的变更)Responsible for Changes impacting API quality34 QC部职责如下,但不仅限于此:The responsib
12、ilities of the Quality Control Department at PTCISH include but are not limited to: 起草、批准部门程序和人员职责Writing and approving department procedures & job description 维护部门文件Maintaining department documents 起草和批准所有物料的公司标准。Writing and approving the specifications for the material used in the company 起草和批准物料检
13、测程序。Writing and approving material test procedures. 制定取样和留样制度Writing and approving sampling and back sampling procedure. 起草和批准检验用设备和仪器的管理办法。Writing and approving the management regulation for equipment of instrument used for analysis. 起草和批准制定试剂、试液、标准品、对照品、滴定液等的管理办法。Writing and approving the manageme
14、nt regulation for the reagent, test solution, standard solution, reference solution, titrant and so on. 负责物料、中间体、产品的取样、检验和留样。Sampling, testing and backing the raw material, packaging material, intermediate and product. 负责分析调查和结果评价Conducting analytical investigations and evaluating results 出具分析报告Writ
15、ing analytical reports 收集数据为确定物料贮存期、成品有效期(稳定性测试)提供数据Gathering data to support retest dates (stability testing) 负责检验方法的验证,包括起草和批准验证方案和报告Validating test methods, including the writing and approval of protocols and reports 实验室设备校验和验证,包括起草批准草案和报告Calibrating and qualifying laboratory equipment including
16、the writing and approval of protocols and reports 评价和批准合同规定的外部实验室Evaluation and approval of contractor s laboratories 维持部门的培训程序和负责操作能力测试Maintaining the overall training program for the department and performing Operation Qualification test. 确保部门人员定期进行GMP培训。Ensuring that Dept. personnel are trained i
17、n GMP regularly.35 生产部职责包括但不仅限于此:The responsibilities of the Production Department at PTCISH include but are not limited to: 起草、批准部门程序,包括中间产品和成品的生产指令。Writing and approving department procedures including instructions for the production of intermediates and final products 维护部门文件Maintaining department
18、 documents 按已批准的程序生产中间产品和成品。Manufacturing intermediates and final products according to pre-approved procedures 按已批准的程序包装、贴签。Packaging, labeling of materials according to approved procedures 审核批生产和包装记录,确保记录无空白。Reviewing batch production and packaging records and ensuring that they are completed and
19、signed 确保记录真实反映生产过程Ensuring regular process record analysis leading to process 若在生产、包装和贴签过程中出现偏差,起草偏差报告。Documenting deviations reported during production or packaging and labeling. 确保生产设施、设备清洁。Ensuring that the production facilities are cleaned 确保厂房、设备状态良好、记录完整。Ensuring that the premises and equipme
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