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WHO关于国际贸易中药品质量证明制度的实施指南1 9 9 2年

WHO关于国际贸易中药品质量证明制度的实施指南1 9 9 2年

WHO关于国际贸易中药品质量证明制度的实施指南1 9 9 2年第45次世界卫生大会注意到WHO关于国际贸易中药品质量证明制度的先前的决议,特别是有关错贴标签、伪造、假冒或低于标准的药物制剂的进出口和走私的WHA 41.16决议;对WHO的修正的药品策略实施报告以及特别对证明制度的实施指南进行评审后;注意到未来的进口国家为取得有关未在出口国家注册的产品的质量明确保证的需求;相信通过本指南的采用,将有助于制止错贴标签、伪造、假冒或低于标准的药物制剂的进出口和走私。

考虑到一个包括WHO证明制度的完整的质量保证体系应建立在可靠的国家许可证制度、独立的成品、分析制度以及独立的检查以保证生产全过程符合已接受的标准(药品生产质量管理规范)的基础上。

1.签署此WHO证明制度实施指南,该指南在与理事会会的药品政策委员会协商后,在必要时予以评估及修订。

2.敦促成员国实施这些指南,并在5年发行—种证书,其格式为根据预先现场检验所取得的经验并一致同意后制定。

第13次全体会议1992年5月14日A45/VR/13第41次世界卫生大会的WHA 4l·18决议中,除其他内容外,又要求总干事在今后的卫生大会中做出WHO修正的药品策略报告,内容中要提供扩大的WHO 证明制度的实施的完成进展情况。

在另一个WHA 41.16决议中,卫生大会还特别要求总干事开展对错贴标签、伪造、假冒或低于标准的药品的进出口和走私进行制止和检查的计划,在制订本文件过程中已经认识到WHO的证明制度有助于制订本文件。

本文件中所转载的指南系与国家药品管理当局和制药工业的代表性组织合作制订的。

这些指南由WHO药品规格标准专家委员会在1990年12月会议上签署的,并对在今后协商过程中可能认为有必要的任何修改不抱有成见。

显然,这些提议将对国家药品管现当局和药品出口国家增加了巨大的额外工作负担,并由于各国间有—定的差距而实施时需要对法定条款修订,因此建议采用本指南时应由WHO的各管理机构提供5年的过渡期以帮助成员国符合这些要求。

欧洲GMP附录15:确认与验证

欧洲GMP附录15:确认与验证

欧洲GMP附件15:确认与验证欧盟委员会,布鲁塞尔2001年7月发布目录原则 (2)验证计划 (2)文件 (2)确认 (3)工艺验证 (4)清洁验证 (6)控制改变 (6)再验证 (7)术语 (7)原则1.这部分说明了适用于药品生产的质量评定与验证的原则。

GMP检查要求厂商确定采用怎样的验证方法来证明控制了特殊操作的关键方面。

设备、仪器和生产过程中发生的可能会影响到产品质量的巨大变化,必须进行验证。

将会采用冒险的评价方法来确定验证的范围和程度。

验证计划2.所有的验证行为都应该预先计划。

验证程序的关键因素应该在总验证计划书(validation master plan)或相当文件中明确的定义和记载。

3.VMP应该是简短、简洁和清楚的概要文件。

4.VMP至少应该包括以下方面:a)验证方法b)验证行为的组织结构c)需要验证的设备、系统、装置和生产过程的概要d)文件格式:协议和报告的格式e)计划编制和行程安排f)改变控制g)参考的现有文献5.如果计划庞大,必须建立主计划的分布验证计划文件6.应建立书面议定书,详细说明怎样进行质量检验和验证。

议定书应该经过评论和核准。

议定书应该详细说明关键步骤和可接受的准则。

7.应该准备涉及到质量检验和/或验证议定书的报告。

报告总结得到的结果,对观察到的任何偏差进行解释,得出必要的结论,包括提出必要的改变弥补不足。

与议定书确定的计划不一样的地方都应该记录并作出合理解释。

8.当满意的质量检验完成后,应该正式发布质量检验和验证的下一步骤。

确认设计确认(DQ)9.新设备、系统或装置验证的首要因素应该设计质量检验标准。

10.设计的质量检验标准与GMP要求是否符合应该进行证明和记录安装确认(IQ)11.安装确认应该在新的或改进的设备、系统和装置上进行。

12.安装确认应该包括,但不仅限于以下几点:a)设备、管道、设施的安装符合现在工程图和规范的要求b)供应者操作和工作设备和维护要求的收集和整理c)校准要求d)厂房建设原料的验证操作确认(OQ)13.操作确认在安装确认之后。

纠正和预防措施程序中英文版

纠正和预防措施程序中英文版

1.0 P URPOSE 目的1.1 The procedure defines the process for Corrective &Preventive Action and ContinuousImprovement and makes sure quality and environment management system is on continuingimprovement and continuously meets customer requirements.确定纠正预防和持续改进的流程,确保公司的质量管理体系和环境管理体系是处于持续改进的,不断满足客户需要。

2.0 S COPE 范围2.1 Apply to the products and processes which are related with quality management system andenvironment management system, such as internal products or processes required correctiveaction or improvement, customer complaint, internal/external audit and environmentnonconformity, KPI over target, and etc.适用于公司内质量管理体系和环境管理体系所涉及的产品和过程。

比如要求纠正或改进的产品、过程,客户投诉,内/外部审核和环境不符合,目标未达成,数据分析等。

3.0 D EFINITIONS定义3.1 Correction: action to eliminate a detected nonconformity. A correction can be, for example,rework or re-grade.纠正:为消除已发现的不合格所采取的措施,如返工,降级等。

浅谈进口药品注册申请中证明性文件的准备

浅谈进口药品注册申请中证明性文件的准备

浅谈进⼝药品注册申请中证明性⽂件的准备“证明性⽂件”是药品申报资料项⽬中最重要的⼀份⽂件,是申请⼈所提供的证明这个药品及该申请符合有关法规的⽂件。

同时,它也是SFDA受理中⼼形式审查的重要内容。

⼀旦证明性⽂件有任何差错或是有不⼀致的地⽅,CFDA都会拒绝接受该申请。

⽽由于证明性⽂件的修改或是重新出具,都需要境外制药⼚商甚⾄是当地药监部门办理,有时更是需要进⾏公证和中国使领馆的认证,因此重新办理往往需要很长时间。

由此可知,注册⼈员必须慎重对待此项⽂件,在申请递交之前就要确保这份⽂件的正确性,否则接到补正通知后再次办理就会耽误申请递交的时间。

在本⽂中,笔者对于进⼝药品注册申请中的证明性⽂件进⾏简单的介绍,希望能够对刚从事该领域的⼈员有所帮助。

根据《药品注册管理办法》(28号令),对于进⼝药品,证明性⽂件包括:1. ⽣产国家或者地区药品管理机构出具的允许药品上市销售及该药品⽣产企业符合药品⽣产质量管理规范的证明⽂件、公证⽂书及其中⽂译本。

2. 由境外制药⼚商常驻中国代表机构办理注册事务的,应当提供《外国企业常驻中国代表机构登记证》复印件。

境外制药⼚商委托中国代理机构代理申报的,应当提供委托⽂书、公证⽂书及其中⽂译本,以及中国代理机构的《营业执照》复印件。

3. 申请的药物或者使⽤的处⽅、⼯艺等专利情况及其权属状态说明,以及对他⼈的专利不构成侵权的声明。

下⾯针对各种不同申请对证明性⽂件做更为详细的解释说明:1. 进⼝药品注册申请进⼝药品申请,是指境外⽣产的药品在中国境内上市销售的注册申请。

对于上⾯提到的⽂件1,申请⼈通常会提供CPP(Certificate of Pharmaceutical Product)证书,这份证书可以同时证明该药品在国外已经批准上市销售以及⽣产企业符合药品⽣产质量管理规范,⽽且⼀般国家出具的CPP证书都符合世界卫⽣组织推荐的统⼀格式,这样也就不需要经所在国公证机构公证及驻所在国中国使领馆的认证。

C-TPAT重点 (2)

C-TPAT重点 (2)

C-TPAT 重點一.安全管理系統1.有否專人負責保安裝備事宜?如有,請提供人名及聯繫電話。

2.是否有書面保安政策及程序包括實體保安、門禁管理、人事保安、教育和培訓、貨櫃保安、提貨單及運輸保安、出入貨物管理以鑒定是否有否超重或短缺以及是否有不明或違法物品。

3.有否準備及更新與執法部門、公司管理層、客戶和承包商的緊急聯繫電話以供不時?4.有否與要處理貴企業出口貨物到美國的運輸及其他服務司的合同中已包含了符合C-TPAT的最低保安要求。

5.有否核實派發物件和信件的人的身份。

二.實體保安及門禁管理1.有否準備實體保安的書面程序。

2.有否在貨物作業和存放区(如货车集装箱擺放区及装卸货区等等)装置围墙栅栏或有天然屏障以阻止非授权人士进?3.是否定期視查工廠周围及内部空旷地帶以確保其狀態良好?4.有否监控所有的出入口以防止非授权车辆出入厂区态,或最低限度,在货物交收,货仓,装货及货物存放的地方?5.有否驗明進出交收貨物司機的有效身份(如身分證或駕駛執照)的措施?6.有否良好的控制裝置(如否安排保安人,电子操纵出入的装置或闭路电视等)阻止非授权人士出入厂区,尤其是在货物交收及貨物存放的地方?7.员工是否配带工作证,是否對無配带者盘问清楚?8.任何访客或生意伙伴是否经管理层批准,保安有否在门口检查他们的身份证?9.工厂内部包括入口大堂以及卸货区同紧急出口是否有照明设备?10.人员进出口,紧急出口,卸装货区的出入口,货柜箱存放区和货物停放的区的照明是否充足?11.所有建筑物是否足以坚固抵制非法侵入,并定期检查?12.是否保持所有门窗统关闭以防非授权人士进入?13.有否安装计算机系統保安装置以防止非授权人士进入该计算机系统?有否要求用户密码,安装系统防火墙,病毒防护装及安全的服务器?14.有否针对出入工具(如锁匙,电子开门卡等)的派发,没收和更改制订书面程序?15.锁及钥匙的使用保管过程或是否由管理人员控制或有其它足够保安的措施?16.墙内外是否清除杂物(如灌木丛,树木或其它植物等等),以保证保安人员的视线无遮无挡,防范有人躲藏或爬入而无法及时发现?三.人事保安&教育及培训意识1.有否对准员工的申请资料(如咨询人,前雇主及公民身份等)加以确认?2.是否員工受訓並有意識分辨可疑或違法行為進行舉报及如何举报?3.有否规定存在离职或被解雇的员工收回工作证及其它财物及更改出入口或计算机的密码(如有的话)?4.是否对准员工进行背景审查,包括依法对这些员工进行犯罪背景调查和申请资料确认?5.有否對身处敏感工作崗位的人员進行定期作檢查或再调查?6.有否對临时工和合同工进行同样的背景调查?7.有否对所有人士作药物测试?四.貨櫃箱保安1.集裝箱裝載貨物前有否書面程序指引如何核實檢驗其完整性及集裝箱門用來安鎖的裝置是否堅固?2.檢驗過程是否包括七個點(前、左、右、底、內外頂、內外門、外底盘)?3.用來鎖集裝箱或拖車的封條保安質量是否達到或超出PAS ISO17712標準,並在裝完貨後馬上上鎖。

品泽生物标准操作规程SOP临床试验CRC协助递交伦理文件制度

品泽生物标准操作规程SOP临床试验CRC协助递交伦理文件制度

品泽生物标准操作规程SOP临床试验CRC协
助递交伦理文件制度
集团标准化工作小组[Q8QX9QTgX8QQB8Q8-NQ8QJ8-M8QMN]
品泽生物标准操作规程(SOP)
PZSW STANDARD OPERATlNG PROCEDURE
版本修改历史(REBISloN HlSTORY))
正式批准(APPROVAL)
规范CRC协助研究者递交伦理文件常规流程。

范围(SCOPE)
适用于本公司所有参与临床研究的CRCO
定义(DEFINmoNS)
Standard OPerating PrOCedUre
规程(PROCEDURE)
CRC部门负责本SOP的审核,全体CRC人员负责SOP的执
意外条款(CONTlNGENClES)
任何情况下不能执行该SOP时要立即报告部门主管。

如果该SOP不能被遵从,则需要立即修改SOP或根据试验采取相应措施。

如果山于某一申办者要求而不能遵从该SOP,则按该研究方案或手册进行。

相关的政策,标准操作规程,工作指南及表格(ASSlCIATED POLs, SOPs, WISs, AND FORS)
适用的法规/指南
(APPLlCABLE REGULATlONS/GUIDELINES)。

巴西药品GMP检查条款

巴西药品GMP检查条款

ANNEX IIIInspection Guidelines Items for the Medicinal Drugs Manufacturers.GMP检查的项目列表ESSENCIAL – E关键检查项目:对产品质量和安全性,与产品接触的员工安全以及整个生产工艺会产生关键影响。

该项目是以“是”或“否”来回答。

NECESSARY - N必要检查项目:对产品质量和安全性,与产品接触的员工安全以及整个生产工艺会产生较为关键的影响。

该项目是以“是”或“否”来回答。

如果必要检查项目在此次验厂中发现不符合要求,那么在今后的验厂中将被划为关键检查项目RECOMMENDED - R建议检查项目:对产品质量和安全性,与产品接触的员工安全以及整个生产工艺会产生非关键的影响。

该项目是以“是”或“否”来回答。

如果建议检查项目在此次验厂中发现不符合要求,那么在今后的验厂中将被划为必要检查项目,但不会被划为关键检查项目。

INFORMATIVE – INF or I信息型检查项目:该项目是指描述性信息,不会对产品质量和安全性,与产品接触的员工安全以及整个生产工艺会产生影响。

该项目可以用“是”或“否”来回答,或者描述一下。

1.- MANAGEMENT AND GENERAL INFORMATION 基本信息The company should submit the required evidence documents. 厂家需提供以下基本文件Nº Qualif. Items 项目 YES NO N/A1.1 INF What is company’s the legal name? 厂家法定名称___________________1.1.1 INF CNPJ 税务登记号_____________________1.1.2 INF Adress 地址: Street / Avenue: ____________________________________N0 _____________, Complement:__________________________Neighborhood:_____________________City:_____________________State:_________________ZIP Code:________________Telephone: ______________________Fax:_________________________________Email: _____________________________1.2 INF Inspection Period:验厂日期 ____/____/____ to ______/_____/_____1.2.1 INF Reason for inspection:验厂原因 ______________________________________1.3 INF Date of last inspection:上次验厂日期 ____/____/____1.3.1 INF Reason for last inspection: 上次验厂原因_______________________1.4 INF Does the company have a Good Manufacturing Practices (GMP) Certification? 公司有GMP证书吗1.4.1 INF Date of Certificate Issue 有的话,证书颁发日期____/___/___1.5 INF Name of the Responsible Technician: 技术负责人姓名____________1.6 E Is the responsible pharmacist presents?负责的药剂师在场吗1.7 E Is there an evidence of his/her certification by the proper agency?有没有相关部门发给过他相关证件?1.8 N Has the company presented an Organizational Chart?公司有没有出示组织机构图?1.9 I Does the company have an Operating Certificate granted by the proper Agency of the National Sanitary Surveillance Agency?公司有没有国家卫生监督局所颁发的运营证书?1.9.1 INF Number 证书号_______________________________________________1.9.2 INF Authorized Activities: 各工叙0 Storing 存储 0 Packaging包装 0 Distribution 销售 0 Exporting 出口0 Importing 进口0 Manufacture 加工 0 Production 生产 0 Transport 运输 0 Re-packaging 再包装0 Extraction 抽提0 Expedition发货 0 Fractioning 分馏 0 Synthesizing 合成 0 Transforming 转化 0 Purifying 纯化1.10 I Does the company have a Special Operating Certificate, granted by the proper Agency of the National Sanitary Surveillance Agency?公司有没有国家卫生监督局所颁发的特别的运营证书?1.10.1 INF Number: 有的话,编号_____________________1.10.2 INF Authorized Activities: 各工叙0 Storing 存储 0 Packaging包装 0 Distribution 销售 0 Exporting 出口0 Importing 进口0 Manufacture 加工 0 Production 生产 0 Transport 运输 0 Re-packaging 再包装0 Extraction 抽提0 Expedition发货 0 Fractioning 分馏 0 Synthesizing 合成 0 Transforming 转化 0 Purifying 纯化 0 Manipulating 操作1.11 I Are the records and inventories of substances subject to a special control conducted according to the Sanitary Laws in place? 根据卫生部的要求,物料的记录和存货清单是否有进行特定的管理?1.12 I Are the losses arising from the manufacture processes of products subject to special controls and properly recorded?产品生产过程中物料的损失是否经过特别控制,并被记录?1.13 I Does the company have an Operating License / Sanitary Authorization from the local Agency?公司有没有当地卫生部授权的生产执照1.13.1 INF Number:执照号 _______________________1.14 Does the company have an authorization from the proper Agencies related to:公司是否有相关部门颁发的下列相关授权/批准:1.14.1 N Environment Protection?环境保护?1.14.2 N Facilities safety (Fireman)? 设施安全(消防员)1.14.3 N Does the company responsible for transportation of raw materials and/or finished products have an operating authorization for such activities, from the proper Sanitary Agency?公司对原粉和/或制剂的运输是否有卫生部门授权/批准?1.15 N Was the building architectural plan presented?厂房建筑方案是否有出示?1.15.1 INF What is the total site area? 总面积 _______________ m21.15.2 INF What is the built area? 建筑面积_____________________m21.15.3 INF How many buildings are there in the plant? 厂里有几栋楼______________1.16 INF Is there a restaurant / cafeteria in the plant?厂里有食堂/自助餐厅吗1.17 N Is there an updated Occupational Health Plan properly signed by the responsible physician? 有没有更新的由负责医生所签字的职业健康计划1.18 N Was a list of proprietary products presented, for those products that are in the market and for the ones that are not?是否有一张已上市的和未上市的专利产品列列表1.18.1 E Are all such products properly registered at the proper National Sanitary Agency?是否所有产品都在当地卫生部有注册1.19 INF What is the company’s production installed capacity, per line / pharmaceutical form?(Attach documentation)公司每条生产线的设计产能(附上文件)1.20 R Was the updated floor plan, approved by the proper Sanitary Agency, presented?有没有卫生部门批准的更新的平面图?1.21 R Are the people and materials flows indicated in the floor plan, updated and approved by the proper Sanitary Agency?人流和物流是否标注在平面图中,并经相关卫生部门批准?1.22 INF Does the company contract third parties’ services fo r the production of their products?产品的生产是否有委托第三方?1.22.1 INF Which are the outsourced products and stages? 委托第三方生产的产品有哪些?进程如何?_____________________________________________________________________________________________________ __________________1.22.2 INF Which are the contracted companies? 委托那些第三方公司______________1.22.3 N Were the Outsourcing Agreements submitted to the evaluation by the proper Sanitary Agency?与委托公司(第三方)协议是否递交给卫生部进行评估?1.22.4 INF Does the company contract third partie s’ services for the production of products subject to special control?委托第三方进行的生产是否经过特殊控制?1.22.4.1 INF Which are the contracted companies? 与哪些公司订约________________1.23 INF Does the company contract third parties’ services for the analysis of raw materials and/or products?原粉及制剂的分析是否有委托第三方?1.23.1 INF Which are the contracted companies? _委托哪家公司?_______________1.23.2 N Which are the conducted assays?做的哪些分析__________________1.23.3 N Were the Outsourcing Agreements for analysis of raw material and/or products submitted to the evaluation by the proper Sanitary Agency?把原粉和制剂的分析委托给第三方的协议是否有递交给相关卫生部门,并由卫生部来评估?1.24 INF Does the company import any raw materials?公司有进口原材料吗?1.25 INF Does the company import any intermediate product?公司有进口中间产品吗?1.26 INF Does the company import any bulk product?公司有进口原液(原粉)吗?1.27 INF Does the company import any finished product?公司有进口制剂吗?1.28 R Has the company submitted the list of imported products (intermediate, bulk, finished products)? 公司有递交进口产品清单吗(包括中间产品,原液(原粉),制剂)1.29 INF Have the lines where imported products are manufactured already been granted a Certificate from the proper Sanitary Agency in Brazil? 进口产品的生产线是否得到巴西卫生部门的许可证1.29.1 N If the answer is NO, has the company already asked for the inspection by the proper Sanitary Agency in Brazil?如果没有,公司是否要求巴西卫生部门来检查?1.30 INF Does the company export finished products?公司出口成品制剂吗1.30.1 R Has the company submitted the list of exported finished products?公司有递交出口的制剂列表吗1.31 INF Is the company active in business related to industrialization of products having a different nature or purpose, subject to an Authorization from the proper Sanitary Agency? 公司从事特殊性质/目的的产品工业化,是否得到相关卫生部门许可/授权?1.31.1 INF Specify All Products. 列出这些所有产品_________________________1.32 N Has the company produced 03 (three) recorded pilot product batches, according to the applicable law? 根据相关法律规定,公司是否有3个批次试生产?1.32.1 INF Where are these batches?这些批号产品在哪里1.32.2 N Are there records?有记录吗2.- PREMISES 厂房设施2.1- Generalities 概述Nº Qualif. Items YES NO N/A2.1.1 INF Are there pollution or contamination sources near the company? 工厂附近有污染源吗2.1. 2 R Are the access ways paved?路有铺好吗2.1.3 N Are the areas surrounding the buildings clean?工厂大楼附近的区域洁净吗2.1.4 R As to the external appearance, do(es) the building present a good conservation state (absence of cracks, leaking, etc.)根据外观来看,工厂大楼是否完好无损(没有破裂,渗漏等等)2.1.5 N Are the effluents treated?废水有处理吗2.1.5.1 INF Which are the treatments? 怎么处理____________________________________________________2.1.5.2 N Are there records? 有处理的记录吗2.1.6 N Are the facilities built in a way to protect against entry of insects and other animals?工厂的建造能否防止昆虫以及别的动物的进入2.1.6.1 N Is there a program in place for prevention and control of insects and other animals?有防止和控制昆虫以及别的动物进入的措施吗?2.2. Ancillary Facilities 辅助设施Nº Qualif. Items YES NO N/A2.2.1 Dressing-Rooms and Bathrooms更衣室和浴室2.2.1.1 R Are there enough changing rooms?有足够多的更衣室吗2.2.1.1.1 N Are the hygiene conditions appropriate?更衣室有良好的卫生条件吗2.2.1.2 R Are there enough bathrooms?有足够多的浴室吗2.2.1.2.1 N Are the hygiene conditions appropriate and is there cold and/or hot water, soap and disposable towels or driers?浴室有良好的卫生条件吗,有冷水/热水,肥皂和一次性毛巾和烘干机吗2.2.1.2.2 N Is the access to the bathrooms independent from the production and storage areas?浴室通道是否与生产及仓储区分离开来?2.2.2 Maintenance / Facilities 维护/设施2.2.2.1 INF Are the maintenance areas physically separated from the production areas?维护区域有跟生产区域分开吗2.2.2.2 INF Is there a specific area for the steam generator equipment?蒸汽发生器有在特定区域呢?2.2.2.2.1 INF Is industrial steam produced? 有生产工业用的蒸汽吗2.2.2.2.2 INF Is pure steam produced?有生产纯蒸汽吗2.2.2.3 INF Is there a specific area for the air compressor? 空气压缩机有在特定区域吗2.2.2.4 INF Is there a specific area for the purified water producing equipment? 纯化水生产的设备是在特定区域吗2.2.2.5 INF Is there a specific area for injection water production equipment? 注射用水生产的设备是在特定区域吗2.2.2.6 INF Is there a specific area for air conditioning equipment? 空调系统的设备有没有在特定区域2.2.2.7 INF Is there a central container for the dust coming from the air exhausting system? 是否有集中收集来自排风系统灰尘的容器?2.2.2.8 N Is there a power generator, if required in an emergency?在紧急状况下,是否有电力发电机2.2.2.9 N Are the water, steam, gas, compressed air and electricity ducts properly labeled?水,蒸汽,气体,压缩空气以及electricity ducts是否有合适区分?2.2.3 Bioterium2.2.3.1 N Are the bioterium facilities independent from the other facilities? 细菌微生物设施与其他设施隔离开来吗2.2.3.2 N Are all the activities carried out in this area compliant with the previously defined Standard Operating Procedures (SOP)?在这里所进行的操作是否遵循SOP2.2.3.2.1 N Are there records for the critical operations defined in the relevant Standard Operating Procedures (SOP)? 是否记录SOP中规定的关键操作?2.2.3.3 N Are the hygienic conditions adequate?那里有合适的卫生条件吗2.2.3.4 N Are there exclusive bathrooms and changing rooms for the staff working with animals? 进行动物实验的员工是否有专门的浴室和更衣室2.2.3.4.1 N Are the hygienic conditions adequate?那里有合适的卫生条件吗2.2.3.5 INF What are the species of the animals? 哪些动物_____________________________________________________2.2.3.6 INF Is the animals’ origin known? 动物的来源知道吗2.2.3.7 INF Is the available area large enough to accommodate the various species utilized?动物实验室是否足够大可以住各种需要用的动物2.2.3.8 N Is the bioterium’s ventilation and/or air conditioning system independent from the other company’s facilities? 细菌微生物房的通风系统/空调系统与工厂其他设施隔开吗2.2.3.9 N Is the light sufficient? 光充足吗2.2.3.10 N Is there a quarantine area for animals? 动物有检疫区域吗2.2.3.11 N Is there a room for inoculated animals? 有动物接种室吗2.2.3.12 N Is there a room for disinfection and drying of boxes, cages, feeders and other required materials ?有对盒子,笼子,进食器和其他需要的材料进行来消毒干燥的房间吗2.2.3.13 N Is there an adequate place for material, food and beds storage for the animals?有没有一个合适的地方来对于动物所需的材料,食品和床进行存储2.2.3.14 N Does the Standard Operating Procedures (SOP) define the treatment to be given to animals dejects and corpses? SOP里有没有规定如何处理动物的废弃物尸体2.2.3.14.1 N Is there an adequate place to store animals dejects and corpses? 有没有足够的地方储存动物尸体?2.2.3.15 N Is there a capacitated professional, responsible for the bioterium? 是否有负责细菌微生物的专业人员?3.- STORAGE ROOM / MATERIALS AND PRODUCTS 仓储区/物料和成品3.1.- GeneralitiesNº Qualif. Items YES NO N/A3.1.1 N Are floors, walls and ceilings appropriate for the activities conducted in the area? 地面, 墙和天花板是否适合于对这块区域的操作3.1.1.1 N Are such items in good conservation state?以上这些地方都保持完好吗3.1.1.2 N Are they easy to clean? 容易清洁吗3.1.1.3 N Are they clean? 干净吗3.1.2 N Is there any protection against entry of rodents, insects, birds and other animals?这些地方有没有防止啮齿动物, 昆虫, 鸟和其他动物进入的措施呢3.1.2.1 N Is there a preventive system in place, related to such? 对以上动物有防护系统吗3.1.2.2 INF Who is the person responsible for carrying out such system?执行这一系统的负责人_______________________________3.1.2.3 INF Were there indications of the presence of rodents, insects, birds or other animals? 当啮齿动物, 昆虫, 鸟和其他动物出现时有指示吗3.1.4 R Is the light adequate? 光照充足吗3.1.5 INF Is it necessary to have humidity and temperature control in the store rooms? 在仓储区有必要对湿度和温度进行控制吗3.1.5.1 N In case it is necessary, are there humidity and temperature controlling devices? 如果有必要, 有湿度和温度控制仪吗3.1.5.2 N Are there records? 有温度和湿度记录吗3.1.6 N Are the temperature and humidity in accordance with the required parameters established for the stored materials and products?温度和湿度是否符合仓储区物料和产品的要求的参数3.1.6.1 N Should there be deviations related to the established parameters, was the cause investigated? 测量值与规定的参数会有偏差吗?起因调查了吗?3.1.6.2 N Are preventive and/or corrective actions taken in relation to the identified causes?有没有对已知的起因实施预防和整改3.1.6.3 N Are there records? 有相关记录吗3.1.7 INF Is a cold chamber necessary? 需要冷库吗3.1.7.1 I Is there a cold chamber? 有冷库吗3.1.7.1.1 N Is the temperature controlled? 冷库温度有控制吗3.1.7.1.2 N Are there temperature records? 有温度记录吗3.1.7.1.3 R Is there an alarm system in the cold chamber, to alert when a temperature deviation occurs? 当温度偏差发生时,冷库里有警报装置吗,3.1.7.1.4 INF What was the reading of the temperature at the time of inspection?验厂时冷库里温度读数多少 ___________ 0C3.2.- Specific ConditionsNº Qualif. Items YES NO N/A3.2.1 N Are all the activities conducted in this area compliant with the previously defined Standard Operating Procedures (SOP)? 在这个区域中所有操作都遵循之前定义的SOP吗3.2.1.1 N Are there records of critical operations defined in the relevant Standard Operating Procedures (SOP)?SOP中规定的关键操作有记录吗?3.2.2.1 N Are the protective suits clean and in good conditions? 防护服干净,完好吗3.2.3 N Are the scales/balances regularly inspected and calibrated? 天平或称有定期检查和校准吗3.2.3.1 INF How often are the scales/balances inspected? 天平或称多久查一次_____3.2.3.1.1 N Are there records? 有记录吗3.2.3.1.2 N Is the inspection conducted by means of standard weights, properly calibrated? 是根据标准砝码来校准的吗3.2.3.2 INF How often are the scales/balances calibrated? 天平或称多久校准一次_____3.2.4 N Is the storage organization rational and correct, aiming at preserving the integrity and identification of materials and products? 仓储结构是否合理,能够识别/区分存放的物料和产品?3.2.5 Is there an area / system limiting or restricting the use of materials/products, respecting the previously defined status for: 在以下定义的情况下, 有没有一个区域/系统来限制物料/产品的使用,3.2.5.1 N Quarantined? 检疫3.2.5.2 N Approved? 批准3.2.5.3 N Returned? 退回3.2.6 Are there areas / systems for keeping: 这些区域/系统用来放3.2.6.1 N Raw materials? 原材料3.2.6.2 N Packaging materials? 包材3.2.6.3 N Intermediate products? 中间产品3.2.6.4 N Bulk products? 原液(原粉)3.2.6.5 N Finished products? 制剂3.2.7 Is there a specific place, supplied with a safety device for keeping substances and products subject to special control, for: 有没有特定区域, 可以提供安全装置来存放需要特殊控制的物料/产品3.2.7.1 E Raw materials? 原材料3.2.7.2 E Intermediate products? 中间产品3.2.7.3 E Finished products? 制剂3.2.8 N Do the control and recording system for storage of intermediate products and bulk products include the maximum permitted storage period of time, before packing?在包装之前,对中间产品和原液(原粉)的控制和记录系统中是否有允许的最长储存期3.2.9 N Do the control and recording system for shipping observe the correspondent sequence relation for batches and expiry dates? 发货的管理以及记录系统是否按照相关批次及过期日期的顺序来进行的?3.2.10 N Are all stored materials and products within the validity term? 所有储存的物料和产品都有效期内吗3.2.11 N Is there a separate, safe and identified area for storage of expired products and/or material, while awaiting their final destination? 有没有一个单独的,安全的,识别的区域来存放过期产品和/或过期物料,在等待它们最终的结果时3.2.11.1 N Will such products and/or materials be destroyed later? 这样的产品和/或物料今后会被销毁吗3.2.12 N Is there a system for inventory control? 有物料管理系统吗3.2.12.1 INF Which system?_ 有哪些系统___________________________________3.2.12.2 N If there are computer systems for materials and products management, does the company assure the system’s safety? 如果有经计算机系统来对物料和产品管理,那么公司能不能保证系统的安全3.2.13 INF Are regular inventories conducted? 定期清点存货吗?3.2.13.1 N Are there records? 有具体记录吗3.2.14 R R Are stored materials and products away from the floor and walls, in order to facilitate cleaning and conservation? 为了保证洁净,所储存的物料和产品是否不接触地板和墙面呢3.3.- Raw materials receipt and storage 原料接收与储存Nº Qualif. Items YES NO N/A3.3.1 N Is the available area consistent with the volume of operations? 是否有足够区域来完成相应操作3.3.2 N Are all the activities carried out in this area compliant with the previously defined Standard Operating Procedures (SOP)? 所有在这区域进行的操作是否符合先前定义的SOP3.3.2.1 N Are there records for the critical operations described in the relevant Standard Operating Procedures (SOP)? 是否记录SOP中的关键操作?3.3.3 N Are raw materials correctly labeled by the supplier/manufacturer? 供应商/生产商有没有对原材料正确地贴标3.3.3.1 N Is the label properly adhered to the container’s body? 标签有没有正确地贴在容器上3.3.4 N Does every raw material batch receive a registration number on receipt? 每一批原料在接收时都有登记号吗?3.3.4.1 N Is the registration number used to identify the raw material up to its final utilization? 登记号是用来识别原料,直到其最后使用之前3.3.5 N Does the label from the company permit the correct identification, visualization or electronic control of the raw material status?标签能否对原料的状态做出正确的识别,可视化或电子控制3.3.5.1 N Is it properly adhered to the container’s body? 标签是正确地贴在容器上吗?3.3.6 N Does the raw material stay quarantined and properly identified as such, before being released by Quality Control? 在QC放行之前,原料是否同样有被检疫和标识?3.3.6.1 N In case of computer controlled inventories, is the use of a quarantined raw material blocked until its release by an authorized person?在电脑控制存货记录的情况下,待检疫的原材料是否是在授权人放行之后才能使用3.3.7 N Is a raw material already approved and identified as such, transferred to the correspondent area/system? 原料是否经批准和识别,然后转入相应区域3.3.8 I Are raw materials used only after release by Quality Control? 原料是否只是在被QC 放行后才使用3.3.9 N Is the expiry date indicated in the label? 过期日期是否有在标签中显示3.3.10 N Is there a reanalysis program for stored raw materials, respecting the validity term established by the manufacturer thereof? 是否对原辅料厂家制定的有效期进行重新分析的程序3.3.10.1 N Is the reanalysis date indicated in the label/system, where applicable? 如果进行重新分析的话,标签/系统中是否有重新分析的日期3.3.11 N Is there a program for Suppliers’ Qualification? 有关于了解供应商资质的程序吗3.3.11.1 N Are the suppliers of active substances qualified? 活性物质供应商合格吗?3.3.11.2 N Are there defined criteria for monitoring the program? 有没有设定的标准来监测控这些程序3.3.12 Does program include: 项目是否包括:3.3.12.1 INF Evaluation of the supplying history? 供应历史的评价3.3.12.2 INF Preliminary evaluation through a questionnaire? 通过调查问卷做初步估计3.3.12.3 INF Quality audits? 质量审核3.3.13 N Are the rejected raw materials properly identified and segregated? 不合格的原料是否适当地鉴别与隔离?3.4.- Packaging materials receipt and storage 包材接收与储存Nº Qualif. Items YES NO N/A3.4.1 N Is the available area consistent with the volume of operations? 是否有足够区域来完成相应操作3.4.2 N Are all the activities carried out in this area compliant with the previously defined Standard Operating Procedures (SOP)? 所有在这区域进行的操作是否符合先前定义的SOP3.4.2.1 N Are there records for the critical operations described in the relevant Standard Operating Procedures (SOP)? 是否记录SOP中的关键操作3.4.3 N Are packaging materials correctly labeled by the supplier/manufacturer? 供应商/生产商对包材是否都有正确的标签3.4.4 N Do packaging materials receive a registration number on receipt? 包材在接收时是否都有一个登记号码?3.4.4.1 N Is the registration number used to identify the packaging material up to its final utilization? 原材料在最后使用之前,其登记号一直用来识别/标识吗3.4.5 N Does the label from the company permit the correct identification, and visualization of the packaging material status? (rejected, quarantined and approved )?标签能否对包材的状态做出正确的识别,可视化或电子控制(退回,检疫还是批准)3.4.6 N Are all the material batches sampled by Quality Control, according to proper and reliable statistical systems? 根据统计系统,是否所有批的原材料QC都要进行取样?3.4.7 N Is the quantity of sampled material according to the established sampling procedure? 材料取样的量是否根据建立的取样程序?3.4.8 N Does the packaging material stay quarantined and properly identified as such, before being released by Quality Control?在QC放行之前,包材是否有被检疫和识别3.4.9 N Is a packaging material already approved and identified as such, transferred to the correspondent area/system? 包材是否在被批准和鉴别后,转入相应区域3.4.10 N Are the rejected materials properly identified and segregated?不合格包材是否有恰当地标识和隔离?3.4.11 R Are the materials deemed old or obsolete destroyed? 旧的原材料是否会被销毁3.4.11.1 N Are there records? 有相关记录吗3.4.12 N Is there a locked sector in the store room, with restricted access, for the printed material? 仓库是否有个锁定的区域,并有限制人员进入,来放已印好的包材3.4.12.1 N Is the access to the restricted area permitted only to authorized personnel? 只有指定人员才能进入这个限定区域吗?3.5.- Intermediate and bulk products receipt and storage 中间产品和原液(原粉)的接收和储存Nº Qualif. Items YES NO N/A3.5.1 Is there an area for storage of products? 有区域来存放以下产品吗3.5.1.1 I Intermediate products? 中间产品3.5.1.2 N Bulk products? 原液(原粉)3.5.2 N Are all the activities carried out in this area compliant with the previously defined Standard Operating Procedures (SOP)? 所有在这区域进行的操作是否符合先前定义的SOP3.5.2.1 N Are there records for the critical operations described in the relevant Standard Operating Procedures (SOP)? 是否记录SOP中规定的关键操作?3.5.3 Are defined procedures for receipt and storage of intermediate and bulk products: 中间产品和原液(原粉)的储存和接受是否所设定的程序3.5.3.1 N Locally produced? 当地生产的3.5.3.2 I Imported? 进口的3.5.4 I Are there locked storerooms or facilities, with restricted access, for intermediate and bulk products subject to special control? 在储藏室中是否有个锁定的区域或设施,并有限制人员进入,用于存放需要特殊控制的中间产品和原液(原粉)3.5.5 N Do the control and recording system for shipping intermediate and bulk products observe the correspondent sequence relation for batches and maximum storage term established for each product? 对中间产品和原液(原粉)的控制和记录系统是否遵循每个产品的批次及最大储存期限的顺序?3.5.6 N Is the storage of intermediate and bulk products conducted with the proper care and safety, in order to prevent potential mixing during control process and shipping errors, as well as accidents when being handled? 为了防止控制过程中可能的混淆,运输错误以及操作中的事故,中间产品和原液(原粉)是否适当安全的储存?3.5.7 N Do the intermediate and bulk products stay quarantined and properly identified as such, before being released by Quality Control? 在QC放行之前,中间产品和原液(原粉)是否有被检疫和识别3.6.- Finished Products receipt and storage 制剂接收和仓储Nº Qualif. Items YES NO N/A3.6.1 N Is there an area for storage of finished products? 有存放制剂的区域吗3.6.2 N Are all the activities carried out in this area compliant with the previously defined Standard Operating Procedures (SOP)? 所有在这区域进行的操作是否跟先前定义的SOP一致3.6.2.1 N Are there records for the critical operations described in the relevant Standard Operating Procedures (SOP)? 是否记录SOP中规定的关键操作?3.6.3 N Do the registration and control system for shipping of finished products observe the correspondent sequence relation for batches and validity term? 制剂运输的记录和控制系统是否遵守批记次和有效期的顺序3.6.4 N Is the storage conducted with the proper care and safety, in order to prevent potential mixing during control and shipping errors, as well as accidents when being handled? 为了防止控制过程中可能的混淆,运输错误以及操作中的事故,制剂是否适当安全的储存?3.6.5 N Do the finished products stay quarantined and properly identified as such, before being released by Quality Control? 在QC放行之前,制剂是否有被检疫和识别3.6.5.1 N If there are computer systems for materials and products management, does the company assu re the system’s safety? 如果有计算机系统来管理物料和产品,那能保证系统的安全吗3.6.6 N Are the products safely stacked? 产品保存安全吗3.6.7 I Are there locked storerooms or facilities, with restricted access, for products subject to special control? 是否有个锁定的区域或设施来存放需要特殊控制的产品,并有限制人员进入3.6.8 N Does the company have established procedures concerning products whose expiry dates are near to their due date?公司有没有建立一套关于即将到效期产品的规程3.6.8.1 N Are such procedures complied with? 这些程序符合相关规定吗3.6.8.2 N Are there records? 有相关规定吗3.6.9 N Does the company have distribution records for products, allowing for tracking of primary distribution client? 公司有没有产品的销售记录,允许跟踪一级分销商3.6.9.1 N Are all primary distribution clients properly authorized by the appropriate Sanitary Agency? 所有一级分销商是否有相关卫生部授权3.7. Raw Materials Sampling Area 原材料取样区Nº Qualif. Items YES NO N/A3.7.1 N Is there a specific room for raw materials sampling? 有没有专门的原材料取样区?3.7.2 N Are all the activities carried out in this area compliant with the previously defined Standard Operating Procedures (SOP)?所有在这区域进行的操作是否跟先前定义的SOP一致3.7.2.1 N Are there records for the critical operations described in the relevant Standard Operating Procedures (SOP)? 是否记录SOP中规定的关键操作?3.7.3 N Are the employees properly dressed (uniformed)? 员工有没有合理着装(制服)3.7.3.1 N Are the uniforms clean? 制服干净吗3.7.4 N Do they wear personal protection equipment, where necessary? 如果需要,他们有戴防护设备吗3.7.5 N Do the facilities present proper hygiene conditions? 设施有良好的卫生条件吗3.7.6 R Does the area have temperature and relative humidity control, where necessary?如果需要,那里有温度和相对湿度的控制吗3.7.6.1 N Are there records? 有相关记录吗3.7.7 N Should there be deviations related to the established parameters, is the cause investigated? 温湿度测试值和设定值之间有没有偏差,如果有,有调查过什么原因吗3.7.7.1 N Are there preventive and/or corrective actions related to the identified causes? 对于这些被识别的原因,有防护或整改的措施吗3.7.7.2 N Are there records? 有相关记录吗3.7.8 INF Are equipment for measurement of pressure differentials required? 需不需要测量压差的设备3.7.8.1 N If yes, are such equipments available?如果需要,是否有这样的设备?3.7.8.2 N Are there records? 有相关记录吗3.7.9 INF Are sterile raw materials sampled? 无菌的原料取样吗3.7.9.1 N Is sampling carried out under Laminar Flow, installed in a classified area? 取样在百级层流下(洁净级为背景)进行吗3.7.9.2 N Are the Laminar Flow and the Area qualified? 百级层流区域条件合格吗3.7.9.3 N Are there records? 有相关记录吗3.7.10 N Are the instruments and appliances used for sampling appropriate? 有没有适当的取样设备与仪器吗3.7.10.1 N Are the instruments and containers that have contact with the raw material cleansed or sterilized, before and after use? 跟原料直接接触的仪器和容器在使用前后有没有进行清洗和灭菌3.7.10.2 N Are such materials identified concerning their cleansing status? 上述仪器或容器是否有洁净状态的标识3.7.11 N Are the sampled containers labeled?取样容器有没有贴标签3.7.12 Content identification testing for containers of the active substances is performed: 装活性物质的容器是否做鉴别测试3.7.12.1 N For all containers? 所有容器吗3.7.12.2 N In a statistical sampling, in the case of Large-Volume Parentereal(注射)Solutions (LVPS) manufacturers, provided that the supplier is qualified: 按统计学取样,对于大容量注射器而言,如果供应商合格,那是否做容器的鉴别测试3.7.13 N Is identification testing for content of an statistical sampling of excipients performed? 辅料容器是否进行鉴别测试3.7.14 N Are the sampling containers labeled and closed after sampling? 做完采样后,取样容器贴上标签并密封吗4.- COMPLAINTS 投诉Nº Qualif. Items YES NO N/A4.1 NN Is there a person appointed for receiving complaints? 是否有专人负责接收投诉4.2 NN Are there Standard Operating Procedures (SOP) for evaluation and actions to be taken concerning the complaints? 是否有SOP来规定如何处理投诉4.3 N Is there a person in charge of decisions and actions to be taken?是否有人负责对投诉做决定和采取措施。

标准预防与职业暴露的处理流程

标准预防与职业暴露的处理流程

标准预防与职业暴露的处理流程Standard precautions and management of occupational exposure are crucial in ensuring the safety and well-being of employees in any workplace. 标准预防和职业暴露的管理对于确保任何工作场所的员工的安全和福祉至关重要。

The first step in the process is to assess the potential risks and hazards in the workplace. 流程的第一步是评估工作场所的潜在风险和危害。

This can be done through conducting a thorough risk assessment to identify any potential sources of exposure to harmful substances or dangerous situations. 这可以通过进行彻底的风险评估来完成,以识别可能对有害物质或危险情况的潜在暴露来源。

Once the potential risks have been identified, the next step is to implement standard precautions to minimize the likelihood of exposure. 一旦确定了潜在风险,下一步就是实施标准预防措施,以最大程度地减少暴露的可能性。

This can involve providing personal protective equipment (PPE) to employees, such as gloves, masks, or protective clothing, to use when handling hazardous materials or working in high-risk areas. 这可能包括向员工提供个人防护装备(PPE),如手套、口罩或防护服,在处理危险材料或在高风险区域工作时使用。

全麻醉操作规范和流程

全麻醉操作规范和流程

全麻醉操作规范和流程英文回答:Anesthesia is a critical component of many medical procedures, and the use of general anesthesia requiresstrict adherence to established protocols and guidelines to ensure patient safety. Here, we will outline the standard operating procedures and workflow for administering general anesthesia.1. Preoperative Assessment: Prior to the administration of general anesthesia, a thorough preoperative assessment of the patient is essential. This includes a review of the patient's medical history, physical examination, and any necessary laboratory or diagnostic tests. The purpose of this assessment is to identify any potential risk factors or contraindications to anesthesia and to tailor the anesthetic plan accordingly.2. Informed Consent: Informed consent must be obtainedfrom the patient or their legal guardian before the administration of general anesthesia. This involves a detailed discussion of the risks, benefits, and alternatives to anesthesia, as well as the specific anesthetic plan for the procedure.3. Preoperative Preparation: The patient should be adequately prepared for anesthesia, which may include fasting for a specified period of time to reduce the risk of aspiration during induction of anesthesia. Preoperative medications, such as anti-anxiety agents or prophylactic antibiotics, may also be administered as indicated.4. Anesthetic Induction: The process of anesthetic induction should be performed in a controlled environment by a qualified anesthesia provider. This involves the gradual administration of anesthetic agents to achieve a state of unconsciousness and loss of sensation. Monitoring of vital signs, including blood pressure, heart rate, and oxygen saturation, is essential throughout this process.5. Maintenance of Anesthesia: Once the patient is in astate of general anesthesia, the anesthesia provider must maintain a careful balance of anesthetic agents to ensure continued unconsciousness and analgesia. Close monitoring of the patient's vital signs and depth of anesthesia is crucial during this phase.6. Emergence and Recovery: As the surgical procedure nears completion, the administration of anesthetic agentsis tapered off to allow for the patient to emerge from anesthesia gradually. Postoperative monitoring in a designated recovery area is essential to ensure thepatient's safe recovery from the effects of anesthesia.7. Postoperative Care: Following the procedure, ongoing monitoring and supportive care may be necessary to manage any residual effects of anesthesia and to address any postoperative complications.中文回答:全麻醉操作规范和流程是非常重要的,需要严格遵守既定的协议和指南,以确保患者的安全。

预防性试验申报流程

预防性试验申报流程

预防性试验申报流程Conducting preventive trials is crucial in advancing medical research and enhancing public health. 预防性试验对于推动医学研究和促进公共健康至关重要。

It is essential for researchers to understand and follow the proper procedures for submitting trial applications. 研究人员必须理解并遵循适当的程序来提交试验申请。

The process of applying for preventive trials involves several key steps that are aimed at ensuring the safety and efficacy of the proposed research. 预防性试验申请的过程涉及几个关键步骤,旨在确保拟议研究的安全性和有效性。

One of the first important steps in the trial application process is to thoroughly review the regulatory requirements for preventive trials. 试验申请流程中的首要重要步骤之一是深入审查预防性试验的监管要求。

Researchers must familiarize themselves with the applicable guidelines and regulations set forth by the relevant authorities. 研究人员必须熟悉相关当局制定的适用指南和法规。

This step is crucial in ensuring that the trial application meets all the necessary legal and ethical standards. 这一步骤对确保试验申请符合所有必要的法律和道德标准至关重要。

院前处方开具管理制度及流程

院前处方开具管理制度及流程

院前处方开具管理制度及流程英文回答:Prehospital Prescribing Management System and Process.Introduction.Prehospital prescribing is an essential aspect of providing timely and effective emergency care. It enables paramedics and other prehospital providers to administer medications in the field, enhancing patient outcomes and potentially reducing the need for hospital transport. To ensure the safe and appropriate use of medications in the prehospital setting, structured management systems and processes are crucial.Key Components of a Prehospital Prescribing Management System.1. Protocols and Guidelines: Comprehensive protocolsand guidelines should be established to guide prehospital providers in the selection and administration of medications. These documents should be based on evidence-based practices and updated regularly to reflect the latest clinical advancements.2. Provider Training and Competency Assessment: Prehospital providers must undergo rigorous training and competency assessment to ensure their proficiency in medication administration. Training programs should cover topics such as pharmacology, drug interactions, and emergency medical procedures.3. Medication Inventory and Storage: Prehospital vehicles should be equipped with standardized medication inventories to ensure the availability of essential medications in the field. Medications should be stored securely and appropriately labeled to prevent errors.4. Electronic Health Records (EHRs): EHRs provide a crucial tool for documenting prehospital prescribing and monitoring patient outcomes. EHRs enable providers toaccess real-time patient information, track medication administration, and facilitate communication with other healthcare professionals.Process for Prehospital Prescribing.1. Patient Assessment: The prehospital providerconducts a thorough patient assessment to determine the appropriate medication(s) to administer. This includes evaluating vital signs, medical history, and any allergiesor contraindications.2. Medication Selection: Based on the patient assessment, the provider selects the appropriatemedication(s) from the standardized inventory. Protocolsand guidelines provide guidance on the selection and dosage of medications.3. Medication Administration: The provider administers the medication(s) according to the prescribed dosage and route of administration. This may involve oral, intravenous, intramuscular, or other methods.4. Patient Monitoring: After medication administration, the provider closely monitors the patient for any adverse reactions or changes in condition. This includes monitoring vital signs, respiratory status, and level of consciousness.5. Documentation: The provider documents all aspects of the prehospital prescribing process in the patient's EHR. This includes the medication(s) administered, dosage, route of administration, time of administration, and any adverse effects observed.Conclusion.A well-structured prehospital prescribing management system and process is essential for ensuring the safe and effective use of medications in the prehospital setting. By adhering to established protocols, providing appropriate provider training, maintaining meticulous medication inventories, and utilizing EHRs, prehospital providers can optimize patient care and improve outcomes.中文回答:院前处方开具管理制度及流程。

预防性保护方案申报流程

预防性保护方案申报流程

预防性保护方案申报流程英文回答:Preventive Protection Scheme Registration Process.The Preventive Protection Scheme (PPS) is a voluntary scheme that allows certain individuals to apply for a court order to protect them from harassment or stalking. The PPS is available to people who have not yet been the victim of a crime, but who have concerns that they may be at risk.To apply for a PPS, you must complete the following steps:1. Submit an application form to the court. The application form is available from the court registry or online.2. Provide evidence that you have concerns that you may be at risk of harassment or stalking. This evidence couldinclude statements from witnesses, police reports, orsocial media posts.3. Attend a hearing before a judge. The judge will consider your evidence and decide whether to grant you a PPS order.If the judge grants you a PPS order, it will be in place for a period of up to 12 months. The order will require the person who is harassing or stalking you to stop their behavior. If the person breaches the order, they could be arrested and charged with a crime.The PPS is a valuable tool for people who are at risk of harassment or stalking. If you are concerned that you may be at risk, I encourage you to apply for a PPS order.中文回答:预防性保护计划申报流程。

中英文纠正预防措施程序文件

中英文纠正预防措施程序文件

Procedure 程序Issue版本:1TITLE:Corrective & Preventive Action Control 标题:糾正和預防措施控制DOC No.文件編號:FQP-CAR01 Pages: 1 of 6Revision History 更改记录Issue 版本Page#页码Rev版次CHANGE更改內容WRITTEN BY编写DATE日期Review and Approval審查和批准Review [ x ] [ x ] [ x ] [ x ] [ x ] [ x ] [ x ] [ x ] [ x ] [ x ] [ x ] Signature / DateISO Officer:________________________QC Sup:_____________________________QE Sup: ____________________________QA Mgr&MR:__________________________ProgramDirector: __________________________PM: ________________________________Store Mgr:_________________________Purchasing Mgr:______________________PMC Sup:_____________________________Shipping Sup:________________________Facility Mgr: ______________________Review[ x ][ x ][ x ][ x ][ x ][ x ][ x ][ x ][ x ]Signature / DateFacility Engineering Mgr:___________________________________ME Mgr:____________________________1st process Mgr:______________________2nd Process Mgr:______________________PPC Mgr: ____________________________Tooling Repair & Maintenance Mgr:___________________________________HR Mgr: ________________________ADM Mgr:_____________________________MIS Mgr:_____________________________APP[ x ]Signature / DatePlant. Manager:____________________Checked by DCC / Date: 文控審核/日期:TITLE:Corrective & Preventive Action Control 标题:糾正和預防措施控制DOC No. Rev文件編號: FQP-CAR01 版次: A Pages: 2 of 6Effective date Expiry date文件生效日期:____________________ 文件失效日期:_________________1.0目的Purpose:消除實際或潛在的不合格因素,及時采取有效的糾正和預防措施,并確保類似問題不再重复發生,以達到自我完善﹑自我提高的目的。

纠正措施与预防措施处理规程-翻译

纠正措施与预防措施处理规程-翻译

1 目的为规范GMP运行过程产生的(潜在)不符合的处理行为,使药品生产符合法规、行业标准规定,降低产品缺陷率及偏差发生的机率,实现质量管理体系的持续改进,特制定纠正措施与预防措施(Corrective Action & Preventive Action,以下简称CAPA)的管理程序。

To regulate the incongruent processing behavior generated in the GMP, and meet the drug production in line with regulations and industry standards, and reduce product defect rate and the probability of the deviation occurrence, and realize the continuous improvement of the quality management system, we specially formulated corrective measures and prevention measures (Corrective Action & Preventive Action, hereinafter referred to as CAPA) management program.2 适用范围2.1 适用于药品GMP运行过程产生的各类(潜在)不符合的CAPA制定、实施及闭环确认。

Applies to all kinds of (potential) formulation, implementation and closed-loop confirmation which do not meet the CAPA in the GMP2.2在生产质量活动中,能够立即采取应急措施解决问题且相关批次产品质量无影响,可以不执行该程序。

SOP-QC吡啦西坦检验操作规程

SOP-QC吡啦西坦检验操作规程

吡拉西坦检验操作规程1. 目的建立吡拉西坦检验标准操作规程,使吡拉西坦检验操作规范化。

2. 范围适用于吡拉西坦的质量检验。

3. 术语或定义3.1 GMP:药品生产质量管理规范(Good Manufacturing Practice)的英文简称。

3.2 SMP:标准管理程序(Standard Management Procedure),用于指导工作的管理类文件。

3.3 SOP:标准操作程序(Standard Operating Procedure),用于指导如何完成一项工作的文件。

4. 职责质量控制部对本规程的实施负责。

5. 程序5.1 检验依据5.1.1 《中国药典》2020年版二部(576页)。

5.1.2 吡拉西坦质量标准(质量标准编号:5.1.3《中国药典》2020年版四部。

1.【性状】1.1本品为白色或类白色的结晶性粉末;无臭。

本品在水中易溶,在乙醇中略溶,在乙醚中几乎不溶。

熔点依熔点测定法操作规程进行测定。

本品的熔点应为151~154℃。

2.【鉴别】2.1鉴别⑴2.1.1试药高锰酸钾试液、氢氧化钠试液2.1.2操作方法取本品0.1g,置点滴板上,加水数滴溶解,加高锰酸钾试液与氢氧化钠试液各1滴,搅匀,放置,溶液应显紫色,渐变成蓝色,最后显绿色。

2.2鉴别⑵在含量测定项下记录的色谱图中,供试品溶液主峰的保留时间应与对照品溶液主峰的保留时间一致。

2.3鉴别⑶2.3.1仪器与用具双光束红外分光光度计、压片机、玛瑙研钵2.3.2操作方法取供试品约1mg,置入玛瑙研钵研细,再取溴化钾粉(约200mg),在玛瑙研钵中充分研磨混匀,移置于直径13mm的压模中,使铺布均匀,加压至20MPa,约60秒取出。

目视检查应均匀,无明显颗粒。

将供试片置于仪器的样品光路中,进行光谱扫描。

供试品的红外光吸收图谱应与对照的图谱(光谱集185图)一致。

3.【检查】3.1溶液的澄清度与颜色取本品2.0g,加水10ml溶解后,溶液应澄清无色;如显浑浊,与1号浊度标准液比较不得更浓。

澳大利亚GMP中文版

澳大利亚GMP中文版

澳大利亚TGA药物良好生产操作规范导言..................................... 错误!未指定书签。

解释..................................... 错误!未指定书签。

第一章质量管理........................... 错误!未指定书签。

原则 ................................. 错误!未指定书签。

质量保证 ............................. 错误!未指定书签。

良好的生产操作规范.................... 错误!未指定书签。

质量控制 ............................. 错误!未指定书签。

第二章人员............................... 错误!未指定书签。

原则 ................................. 错误!未指定书签。

一般原理 ............................. 错误!未指定书签。

关键人员 ............................. 错误!未指定书签。

培训 ................................. 错误!未指定书签。

个人卫生 ............................. 错误!未指定书签。

第三章厂房与设备......................... 错误!未指定书签。

原则 ................................. 错误!未指定书签。

厂房 ................................. 错误!未指定书签。

原则.............................. 错误!未指定书签。

生产区............................ 错误!未指定书签。

EP凡例2

EP凡例2

.0凡例1.1总体概述总体概述适用于所有的专论和另外的欧洲药典中的其它内容。

欧洲药典的官方内容以法语和英语出版。

欧洲药典公约的签署国可以将其翻译成另外的语言。

如有疑问或争议,英语和法语版本具有单独的权威性。

在欧洲药典的内容中,‘药典’一词,没有标明资格的表示欧洲药典。

官方缩写Ph.Eur.用来定义欧洲药典。

专论标题和副标题的使用意味着文章符合相关专论的要求。

这样的对药典专论内容的参考以专论标题和斜体的参考页码表示。

制备过程必须完全遵守其整个有效期;打开的或者开盖容器的单独的有效期和/或规格由主管当局决定。

任何另外的专论的内容必须遵守其有效期。

有效期标注在任何给出的产品中,有效期从哪天开始计算由主管当局根据稳定性实验结果来决定。

除非在凡例和专论中另有指定,专论中的说明为强制性要求。

当在专论中涉及通用章节时,通用章节变成法定要求,除非这种提及的方式表明,它不打算使提到的文字作为强制性要求,而只是引用它的信息。

活性成分(药用物质),赋形剂,(辅助药物),药物制剂,和另外专论中提到意欲用于人和兽的的产品(除非明确严格的规定用于其中一个)。

除非产品符合专论中的所有要求,否则它就不符合药典的质量要求。

但这并不表示厂商在放行产品前评估产品是否符合药典要求的先决条件是进行专论中的所有测试。

生产厂商可以从导出的数据来保证产品具有药典规定的质量,例如,生产过程和进程内控制的验证。

在特定情况下,参数释放被主管当局视为适合的,但并没有排除符合药典要求的需要。

描述的试验和分析方法都是在药典标准的基础之上的官方原理。

在主管当局的认可下,为了控制目的而采用的分析的替代原理也可用。

如果官方原理被使用,可以对是否符合专论标准作出明确的判断。

在发生疑问或者争议时,药典的原理单独具有权威性。

特定的物料可能出现在药典专论中为了适应不同的目的而设的不同的等级中。

除非在专论中另有指定,这些要求适用于所有等级的物料。

在一些专论中,特别是那些关于赋形剂的,功能相关特性的列表关于物质的使用信息附在专论信息中,测定其中一个或者更多的特性的原理也作为信息给出。

CLP 法规 防范说明(Precautionary Statements)解释

CLP 法规 防范说明(Precautionary Statements)解释

CLP 法规 防范说明(Precautionary Statements)解释
1.1 防范说明-一般的
编码 一般的防范说明 英文原文 P101 Ifmedicaladviceisneeded,haveproductcontainerorlabelat hand. P102 Keepoutofreachofchildren. P103 Readlabelbeforeuse. 中文解释 如果需要医疗建议,要有产品容器或标 签。 远离儿童。 使用前先阅读标签。

P311 P312 P313 P314 P315 P320 CallaPOISONCENTERordoctor/physician. CallaPOISONCENTERordoctor/physicianifyou feelunwell. Getmedicaladvice/attention. Getmedicaladvice/attentionifyoufeelunwell. Getimmediatemedicaladvice/attention. Specifictreatmentisurgent(see … onthislabel). 求医/就诊。 若感觉不适,求医/就诊。 立即求医/就诊。 紧急的特殊明确的治疗 (见本标签上的... ) 。 (参 考的补充急救指示。-如需立即服用解毒药是必需 的。 ) P321 Specifictreatment(see …onthislabel). 特殊明确的治疗 (见 (参考的补充急救指示。需的。 ) (参考的补充急救指示。如立即采取具体措施是必 需的。 ) (参考的补充急救指示。如立即采取措施是必需 的。 ) (参考的补充急救指示。制造商/供应商可规定一种 适当的清洗剂。 ) P322 Specificmeasures(see …onthislabel). 特殊明确的措施 (见 本标签上 …) 。 (参考的补充急救说明。如具体建议的清洁剂等紧 急措施。 ) (参考的补充急救说明。如具体建议的清洁剂等措 施。 ) P330 P331 P332 P333 P334 P335 P336 P337 P338 P340 P341 P342 Rinsemouth. DoNOTinducevomiting. Ifskinirritationoccurs: Ifskinirritationorrashoccurs: Immerseincoolwater/wrapinwetbandages. Brushofflooseparticlesfromskin. Thawfrostedpartswithlukewarmwater.Donotrub affectedarea. Ifeyeirritationpersists: Removecontactlenses,ifpresentandeasytodo. Continuerinsing. Removevictimtofreshairandkeepatrestina positioncomfortableforbreathing. keepatrestinapositioncomfortableforbreathing. Ifexperiencingrespiratorysymptoms: 将受害者移到新鲜空气处,在呼吸舒适的地方保 持休息。 舒适的地方保持休息。 如果出现呼吸道症状: 如果眼刺激: 如果现在容易做到,拿掉隐形眼镜,继续冲洗。 漱口。 不要引吐。 如发生皮肤刺激: 如果发生皮肤刺激或皮疹: 浸入冷水中/用湿绷带包扎。 掸掉皮肤的细小颗粒。 用温水解冻冻伤部分。不要摩擦患处。 本标签上的... ) 。 如需立即服用解毒药是必 呼叫解毒中心/医生。 如果你感到不适,呼叫解毒中心/医生。
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Step The Temporary Chair appoints a temporary Two secretary of the convention
Step
calls for all Qualified members of the Party to sign in on Exhibit A with their presidential preference. “Qualified” means that they voted in 2019 Democratic primary and reside in that precinct. Please verify on the voter roll if you were able to pick it up from the election judge.
Step Four
Temporary Chair announces that the convention will be conducted in accordance with the Texas Election Code and the Rules adopted by the Party in accordance with Section 163.002 of the Election Code, and that the 2000 edition of the Roberts Rules of Order, Newly Revised will govern parliamentary procedure. (See the back of TDP Rules for briefing on Parliamentary Procedure. ) Temporary Chair announces that a copy of the party Rules is available for inspection. (This will be in your packet.)
Step Ten, Continued
After the number and percent of presidential preference or uncommitted status are announced and accepted by the convention, anyone else who signs in will be able to participate, but will not change the established percentages required for a caucus. Their names should be marked with an asterisk: *
each CAUCUS Line 2 Enter the Total number of eligible participants at
CONVENTION Line 3 % of Convention (divide line 1 by line 2) Line 4 Enter Total Number of delegates to which your
Step Thirteen
Determine how many delegates each caucus gets. The Formula is: Total # in Caucus/Total # at Precinct Convention X Total # of SD or County Delegates to which Precinct is Entitled (Round DOWN) If there is an unallocated delegate, the caucus with the highest fraction gets the delegate.
Worksheet to determine the # of delegates each caucus gets
Clinton Obama Uncommitted Total Line 1 Enter the total number of eligible people signed in for
Precinct Convention minutes)
Step Election for Permanent Secretary by majority vote. Eight (Enter the name in the Precinct Convention minutes.)
Step Calculate the Number and Percentages of each Nine Presidential Preference or Uncommitted Status
PRECINCT CONVENTION PROCEDURES
STEP BY STEP INSTRUCTIONS
Step One
Temporary Chair calls convention to order. (This position is generally filled by the precinct chair; however, any qualified voter (resides in that precinct and voted the Democratic primary) can assume the position of Temporary Chair of the convention) Note: The precinct convention cannot begin prior to 7:15, and it cannot begin until the last voter in line has voted and been given an opportunity to sign in at the precinct convention.
Step Ten Permanent Chair announces: •Number of eligible voters on roll (Exhibit A) •Number of delegates and alternates to the County/Senatorial Convention (on the front of your packet) •Number and percent of eligible members signed in for each presidential and uncommitted preference. The Chair should call for the convention to accept the report. Enter this information in the Precinct Convention Minutes.
Step Election for Permanent Chair by majority vote. (Enter
Six the name in the Precinct Convention minutes.)
Step Permanent Chair calls for nominations for Permanent Seven Secretary. (These names should be entered in the
Enter number of people attending your convention (from Exhibit A sign-in sheet) This is the number that was announced by the Chair and accepted by the convention. Enter number of delegates to the SD/County Convention to which your precinct is entitled. This will be on the front of the packet.
at your convention. From Exhibit A, count the number of participants signed in for EACH PREFERENCE and the TOTAL OF ALL SIGNED IN and divide EACH PREFERENCE TOTAL by the total number of eligible participants of the convention signed in on Exhibit A. (Total of each preference/Total signed in=% of each preference)
Step Eleven (Work sheet)
Line 1
Line 2
Line 3
Line 4
Determine the number of people needed to make a caucus The formula is: Total # attending convention/Delegates to which your precinct is entitled You must ROUND UP!
Divide line 1 by line 2, extending to two decimal places If Line 3 is not a whole number, round UP to the next whole number. This is the number people required to make a caucus.
Step The Temporary Chair calls for nominations of Five Permanent Chair. (These names should be
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