注射剂作业的环境监测与合规 - PDA技术报告13 EM Program Per PDA TR-13 For GMP Compliance 李树德Michael Lee June 20, 2013 环境监测 日常无菌保证 法规和标准 References • USP 1116 Microbiological evaluation of clean rooms and other
-PDA技术报告13 EMProgramPerPDATR-13 ForGMPCompliance 李树德MichaelLee June20,2013 环境监测 日常无菌保证 法规和标准 •USP<1116>Microbiologicalevaluationofclean roomsandothercontrolledenvironments •PDATechnicalreportNo.44Qualityrisk managementforasepticprocess •PDATechnicalreportNo.13Fundamentalsofan Environm...
2015 PDA TECHNICAL REPORT NO. 13 REVISEDFUNDAMENTALS OF AN ENVIRONMENTALMONITORING PROGRAM 技术报告 13：环境监测 Table of Contents 目录 1.0 INTRODUCTION 简介. . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 2....
1 / 91 翻译:杨勇 校对:杨勇 排版:杨勇 水平有限,有纰漏之处,望大家谅解并给予修正 Technical Report No. 13 (Revised 2022) Fundamentals of an Environmental Monitoring Program 技术报告第 13 号( 2022 年修订) 环境监测计划的基础本资料仅供学习交流严禁使用于任何商业用途!
北京齐力佳科技有限公司提供 2022-05-05 Technical Report No. 13 (Revised 2022) 技术报告第 13 号(2022 年修订) Fundamentals of an Environmental Monitoring Program 环境监测计划的基础 本文件来自网络,翻译来自翻译网站,本文仅供个人学习使用,齐力佳不保证原文及翻译的准确性完整性。 北京齐力佳科技有限公司提供...
PDATECHNICALREPORTNO.13 REVISEDFUNDAMENTALSOFANENVIRONMENTALMONITORING PROGRAM 技术报告13:环境监测 TableofContents目录 1.0INTRODUCTION简介...1 2.0ENVIRONMENTALCLASSIFICATIONS环境分级...1 3.0SURVEILLANCESUPPORT监视支持...6 3.1CleaningandSanitization/Disinfection清洗和杀菌/消毒...6 3.2SampleSiteSelection取样...
Technical Report No.11 - Sterilization of Parenterals by Gamma Radiation Technical Report No.12 - Siliconization of Parenteral Drug Packaging Components Technical Report No.13 - Fundamentals of a Microbiological Environmental Monitoring Program Technical Report No.14 - Industry Perspective on the Validation...
These assays must be performed in a GMP laboratory following established SOPs. ICH Q2(R1) and PDA Technical Report No. 57: Analytical Method Validation and Transfer for Biotechnology Products provide detailed guidance for the validation of analytical methods (26,49).这些分析必须在GMP实验室按照既定的...
TechnicalReportNo.13-FundamentalsofaMicrobiologicalEnvironmentalMonitoringProgram TechnicalReportNo.14-IndustryPerspectiveontheValidationofColumn-BasedSeparationProcessesforthePurificationofProteins TechnicalReportNo.15-IndustryPerspectiveonValidationofTangentialFlowFiltrationinBio-pharmaceuticalApplication ...
It expandssubstantially upon the first edition of Technical Report No. 13, Fundamentalsof a Microbiological Environmental Monitoring Program, published by PDA in1990. While this publication cannot possibly supplant the wealth ofinformation published on this subject, it provides summary information and...