PDA技术报告目录
更新时间:2023-11-29 09:04:01 阅读量: 教育文库 文档下载
PDA——Parenteral Drug Association,注射用药物协会(http://www.pda.org/)
PDA技术报告目录/PDA Publications
● Technical Methods Bulletin No.
1 - Extractables from Elastomeric Closures: Analytical Procedures for Functional Group Characterization/Identification
2 - Elastomeric Closures: Evaluation of Significant Performance and Identity Characteristics
3 - Glass Containers for Small Volume Parenteral Products: Factors for Selection and Test Methods for Identification
● Technical Information Bulletin No.
2 - Generic Test Procedures for Elastomeric Closures 4 - Aspects of Container/Closure Integrity
● Technical Report No.
1 Validation of Moist Heat Sterilization Processes: Cycle Design, Development, Qualification and Ongoing Control, Revised 2007 (original Technical Monograph No. 1, Validation of Steam Sterilization Cycles, first published in 1978)
Technical Monograph No. 2 - Validation of Aseptic Filling for Solution Drug Product, 1980 (replaced by Technical Report No. 22 and is no longer available.)
3 Validation of Dry Heat Processes used for Sterilisation and Depyrogenation, 1981
4 Design Concepts for the Validation of a Water for Injection System, 1983
5 Sterile Pharmaceutical Packaging: Compatibility and Stability, 1984
6 Validation of Aseptic Drug Powder Filling Processes, 1984 (replaced by Technical Report No. 22 and is no longer available.) 7 Depyrogenation, 1985
8 Parametric Release of Parenteral Solutions Sterilized by Moist Heat Sterilization,
1987 (Please note: Technical Report No. 8 has been superseded by Technical Report No. 30 and is no longer available.)
9 Review of Commercially Available Particulate Measurement Systems, 1988
10 Parenteral Formulations of Proteins & Peptides: Stability and Stabilizers, 1988
11 Sterilization of Parenterals by Gamma Radiation, 1988
12 Siliconization of Parenteral Drug Packaging Components, 1988 13 Fundamentals of a Microbiological Environmental Monitoring Program, 1990 (Revised 2001)
14 Validation of Column-Based Chromatography Processes for the Purification of Proteins, Revised 2008 (original name: Industry Perspective on the Validation of Column-Based Separation
Processes for the Purification of Proteins, first published in 1992) 15 Industry Perspective on Validation of Tangential Flow
Filtration in Bio-pharmaceutical Application, 1992 (Revised 2009) 16 Effect of Gamma Irradiation on Elastomeric Closures, 1992
17 Current Practices in the Validation of Aseptic Processing - 1992, 1993
18 PDA Report on the Validation of Computer Related Systems, 1995
19 Rapid/Automated ID Methods Survey, 1990
20 Report on Survey of Current Industry Gowning Practices, 1990 21 Bioburden Recovery Validation, 1990
22 Process Simulation Testing for Aseptically Filled Products, 1996
23 Industry Survey on Current Sterile Filtration Practices, 1996 24 Current Practices in the Validation of Aseptic Processing - 1996, 1996
25 Blend Uniformity Analysis: Validation and In-Process Testin, 1997
26 Sterilizing Filtration of Liquids, 1998 (Revised 2008) 27 Pharmaceutical Package Integrity, 1998
28 Process Simulation Testing for Sterile Bulk Pharmaceutical Chemicals, 1998 (revised 2006)
29 Points to consider for Cleaning Validation, 1998
30 Parametric Release of Pharmaceuticals Terminally Sterilized by Moist Heat, 1999
31 Validation & Qualification of Computerized Laboratory Data Acquisition Systems, 1999
32 Auditing of Suppliers Providing Computer Products and
Services for Regulated Pharmaceutical Operations, 1999 (revised 2004)
33 Evaluation, Validation & Implementation of New Microbiological Testing Methods, 2000
34 Design and Validation of Isolator Systems for the
Manufacturing and Testing of Health Care Products, 2001
35 A Proposed Training Model for the Microbiological Function in the Pharmaceutical Industry, 2001
36 Current Practices in the Validation of Aseptic Processing - 2001, 2002
38 Manufacturing Chromatography Systems Post-Approval Changes: (ChromPAC): Chemistry, Manufacturing and Controls Documentation, 2006
39 Guidance for Temperature-Controlled Medicinal Products: Maintaining the Quality of Temperature-Sensitive Medicinal Products through the Transportation Environment, revised 2007 (orginal name: Cold Chain Guidance for Medicinal Products: Maintaining the Quality of Temperature-Sensitive Medicinal
Products Through the Transportation Environment, first published in 2005)
40 Sterilizing Filtration of Gases, 2005 41 Virus Filtration, 2005 (revised 2008)
42 Process Validation of Protein Manufacturing, 2005
43 Identification and Classification of Nonconformities in Molded and Tubular Glass Containers for Pharmaceutical Manufacturing, 2007
44 Quality Risk Management for Aseptic Processes, 2008
45 Filtration of Liquids Using Cellulose-Based Depth Filters, 2008 46 Last Mile: Guidance for Good Distribution Practices for Pharmaceutical Products to the End User, 2010
47 Preparation of Virus Spikes Used for Virus Clearance Studies, 2010
48 Moist Heat Sterilizer Systems: Design, Commissioning, Operation, Qualification and Maintenance, 2010
PDA的技术报告目录/刊物 技术方法
第1号-萃取物从弹性封路措施:分析程序功能群表征/鉴定 2 弹性封路措施:对重要的性能和身份特征评价
3 小容量注射用玻璃容器:选择和试验方法因素的识别 技术信息通报
1 蒸汽灭菌周期验证
2 对弹性封通用测试程序
3 验证流程,干热灭菌和除热源使用 4 为一个注射水系统验证设计概念 5 无菌医药包装:兼容性和稳定性 6
7 除热源
8 肠外参数解湿热灭菌消毒释放 1987年(注意:技术报告已被第8号第30号技术报告取代,不再可用) 9 审查颗粒测量系统投放市场
10 注射制剂的蛋白质及肽:稳定性和稳定剂 11 由伽马辐射肠道灭菌 12 肠外药品包装成分渗Si
13 一个微生物环境监测方案基础
14 行业对基于列的分离工艺验证的角度来看,用于蛋白质的分离纯化
15 关于切向流过滤验证产业视角在生物医药中应用 16 γ-辐射对弹性封
17 当前实践中的无菌工艺验证? 1992年 18 掌上报告计算机相关系统验证 19 快速/自动调查ID方法
20 对当前行业调查报告gowning 实践 21 生物负载恢复验证
22 无菌填充过程的仿真测试产品 23 关于当前产业调查无菌过滤实验 24 当前实践中的无菌工艺验证 1996年 25 混合均匀度分析:验证和流程测试 26 液体过滤杀菌
27 医药软件包的完整性
28 过程无菌原料药化工仿真测试 29 点考虑清洗验证
30 药品参数放行末由湿热灭菌
31 计算机实验室验证及数据采集系统的鉴定
32 中医药部分提供受规管电脑产品及服务供应商审核 33 评估,验证和测试新方法的实施微生物 34 设计及制造及保健品的隔振系统验证测试 35 微生物的作用,为拟议的培训模式在制药行业 36 现行做法是无菌生产过程的验证 2001 37 38
39 对药品冷链指导:维护交通环境,通过对温度敏感的药品产品质量
40 气体过滤杀菌 41 病毒过滤
42 蛋白质制造工艺验证
43 识别及铸模,管状玻璃容器不符合药品生产的分类 44 质量风险管理过程的无菌
45 利用纤维素为基层的深层过滤液体 2008年过滤
正在阅读:
PDA技术报告目录11-29
虽然吸电子烟更安全,但大家对它的看法和普通烟还是没差05-04
城市“富贵病”知多少05-27
祝寿02-19
公司开业庆典贺词12-13
物流信息系统--业务流程图04-24
DCS系统在石油化工中的应用04-07
- exercise2
- 铅锌矿详查地质设计 - 图文
- 厨余垃圾、餐厨垃圾堆肥系统设计方案
- 陈明珠开题报告
- 化工原理精选例题
- 政府形象宣传册营销案例
- 小学一至三年级语文阅读专项练习题
- 2014.民诉 期末考试 复习题
- 巅峰智业 - 做好顶层设计对建设城市的重要意义
- (三起)冀教版三年级英语上册Unit4 Lesson24练习题及答案
- 2017年实心轮胎现状及发展趋势分析(目录)
- 基于GIS的农用地定级技术研究定稿
- 2017-2022年中国医疗保健市场调查与市场前景预测报告(目录) - 图文
- 作业
- OFDM技术仿真(MATLAB代码) - 图文
- Android工程师笔试题及答案
- 生命密码联合密码
- 空间地上权若干法律问题探究
- 江苏学业水平测试《机械基础》模拟试题
- 选课走班实施方案
- 目录
- 报告
- 技术
- PDA
- 2018-2019-201X年武汉中考考试分数线公布word版本(3页)
- 幼儿园小班上学期班务工作总结
- 技能抽查(答案)运输成本核算及运输费用的计算
- 关于森林资源保护与生态环境建设的思考
- 初级安全主任复审试题
- 性别图式理论
- 2017年劳资工作总结
- 2017-2018学年江苏省南京市秦淮区八年级(下)期末数学试卷(含解析)
- 2019最新物理(人教版)中考复习学案第十一章热和能word版
- 梦想作文之乘着梦想的翅膀作文高中
- 2019届北京市朝阳区高三上学期期末考试数学(文)试卷及解析
- 混凝土子分部验收各个检验批内容
- 2018学年九年级上册数学全册教学设计 人教版1〔优秀篇〕
- 吉安教师招聘面试培训班
- 四种产品生产工艺流程及产污节点图
- 2011华安县最新科目四货车试题 -
- 人教版小学五年级数学上册第七单元
- 图形推理的十大规律
- 上半年乡镇街道市政卫生计生科工作总结-精选模板
- 2017年湖北省黄冈市中考物理二模试卷及参考答案