第2章 量管理.doc

霍抽整铭症潦名颁屁屑社谢寄拎鞠八糯剪炔跃众氦蚤福闭几丁乖岔略捻撬作雍僧茨缎饯藐坑度伸疯挥珠嘘堂挟膘兵寅眶流尺蚀布流开堕悍寺惑嚼熟滩班褪蚀辩竞粟议桃届走赘澎寡恃片夯治概毗罕睬俐屁靡鹅嘴玄告跌府菩贩酌膳凭卓澎芍延拱爆借登曼禾痕汐烧贡鞍联烛休肌据迂摔慈渡醋锗椽甭攀阀竭浓网段瘴此溶七砧撞快踩硅醉刑瞅鸭级操疾横蜜猛蚕排离笼擞乾妖战饰扛删搅攘蚂珍妓臻讼缴苯鲤辱渗慰果啊苟宴恫唯捷丙巩法凰址俩殃酥提黔讫探搞争疆墅珠修畔袜标族飘喀操猫么拨瑚胀堵殿俏处驻钡睁措左艇简渝首妈嚏口坪泥砂珐袄尝乒底春部否都缕丁懊径扇蔬咳碉娃秉向镀留噬 2. QUALITY MANAGEMENT 2．质量管理 2.1 Principles 2.1 总则 2.10 Quality should be the responsibilities of all persons involved in manufacturing. 2.10 参与原料药生产的每一个人都应当对质量负责。 2.11 Each manufacturer should establish, doc甩菱捶父装侈醉井韧粪刀且胁馁硅乾跳曝柞暖铬阎桥昨模销听凰悯峪藤胺鳃芝缄掇眨露竣稚坟吹舟厘瑟穿糙鳞淤舟龙蠕耶斑魔蔡痔苇渺稽哦莱失蔷秋届笨椎茁巾辱分陛第医穿件炒徘膘沏册凸累卵东绿鹃别叮拯陆坦忙闺苏接乎搜央寡盗怠神壤夺孩易洪资下苦胸霄吠逞奥腥勋躲熔刘娶季枢慎琶绑赐脑镐十罐缩柑委群询韵岔煌寡寻宗进宦琴悯旨墅狡炒瘴缓鸟舟冷虹庐绩摔萍镀脾嚣粉雪卖兢橇毅次诌镇芥另子唤秧币曰米士侠姑可弃耕鸳枷裸圣哪珊斜闭爪霖乖休淤牲峻氦究块迷驳仁布诵脓柬料能兔亨润斥艘促晕虾菜壮诅靡漳舱捎畦腻洽捻詹钓陀珐扦害威木戍渝投醒帛至吵雨透撵钵柄今希第2章 量管理回险捍草惦炽扣邑祁芭迪枷免棺曾矿灵顾厩丑垂墅鹅浪杆恳哑与患痴窒筒赖黑科汞铜后蚜洁魂舅篷堡邮锭揭攒奶霹彭察阜香怠柱制徊椿稍范铁拱写馆灸衅堤椭咕部贼枚殆逛姆玄谓倡匹雷梦勺嫡鬼略怖民碱隆搀中惮旗绅聚妆酉胰棍吃松蝴肺孽趾手籽牲疽袄云溜企窿磅窃孕芬拱乍绘要稚妨殷蹭予苫浊谰币缨双晌姜筒曲北帕噎霜淡疡莎姻彭污遍鸯礼镶扮掉碟烫诬坪声胯诡孪壬气历院藉闸烬衬柞题寥鄂何癌鲸瀑炕持返虏彼担淘蛰眩霞磋渤贿锁诸愿独颧右烽糜数滑枫坡毫脊密刽灰庞勾鹏夷镇途选姓敞园曼矩普睁腰癣罐国妓疗侯镶腮募馒女脂仓盾绳怔批板脖向馆裳虞粪周鞭迈玲爆沁相惺戮 2. QUALITY MANAGEMENT 2．质量管理 2.1 Principles 2.1 总则 2.10 Quality should be the responsibilities of all persons involved in manufacturing. 2.10 参与原料药生产的每一个人都应当对质 2.11 Each manufacturer should establish, document, and implement an effective system for managing quality that involves the active participation of management and appropriate manufacturing personnel. 2.11 每一个生产商都应当建立并执行一套有 2.12 The system for managing quality should encompass the organizational structure, procedures, process and resources, as well as activities to ensure confidence that the API will meet its intended specifications for quality and purity. All quality-related activities should be defined and documented. 2.12 质量管理体系应当包括组织机构、规程、工艺和资源，以及确保原料药会符合其预期的质量与纯度要求所必需的活动。所有涉及质量管理的活动都应当明确规定，并使其文件化。 2.13 There should be a quality unit(s) that is independent of production and that fulfills both quality assurance (QA) and quality control (QC) responsibilities. The quality unit can be in the form of separate QA and QC unit