Validation_master_plan验证主计划参考.doc,PAGE Pag. PAGE 8 / NUMPAGES 48 VALIDATION MASTER PLAN 验证主计划 (China) Co., Ltd. MANUFACTURING PLANT 有限公司工厂 PREPARED BY: 制定人: QA MANAGER QA经理 CHECKED BY: 审核人: HEAD OF QA 质量经理 APPROVED BY: 批
10. GUIDELINES Preparation and Maintenance of the Validation Master Plan HQ-QO-171- AP03-01 验证主计划的准备和维护 HQ-QO-171- AP03-01 Pag. 44 / 48 ANNEX 1. ORGANIZATION CHART 附录 1:组织机构图 ANNEX 2: LIST OF ROOMS IN GMP AREA 附录 2:GMP 房间清单 ROOM AIR LOCK 气闸室 locke...
GUIDELINES 45ANNEX1.ORGANIZATIONCHART附录1:组织机构图 46ANNEX2:LISTOFROOMSINGMPAREA附录2:GMP房间清单 47ANNEX3:Annualvalidationplan附录3:年度验证计划 50 INTRODUCTION 简介Validationpolicy 验证方针Validationisapartofourqualitypolicy.Webelieveinitasaconceptwhichprovidesbothregulatorycomplianceandcostbenefits.Itisthe...
这个模块完成时参与者应该能够：InterpretGMPrequirementsandguidelinesforpreparingValidationMasterPlans.解读GMP的要求和指南为验证主计划做准备 SuggestthestructureofaVMPandexamplesofschedules,scopeofwork&VMPsections.建议一个验证主计划结构、附表的例子、工作范围和验证主计划章节。Understandprospectiveand...
1. VALIDATION MASTER PLAN 1.1. Principle 1.1.1. Validation requires a meticulous preparation and careful planning of the various steps in the process. All work involved should be carried out in a structured way according to formally authorised standardised working procedures. Validation is characterised...
Deviation investigation guidelines in the pharmaceutical industry June 28, 2024 Overview of pharmaceutical quality control steps and implementations June 10, 2024 What is analytical laboratory management in pharmaceutical? June 6, 2024 Validation master plan (VMP) – when and how to create one? June ...
验证总计划模板Validation Master Plan Template验证主计划 Validation Master Plan 起草人Preparedby 部门Department 打印体姓名PrintName 签字/日期Signature/Date 质量部Quality 审核人Reviewedby 部门Department 打印体姓名PrintName 签字/日期Signature/Date 工程设备部 EngineeringEquipment 生产部 Production 质量控制 Quality...
2.3 Manufacturers should plan validation in a manner that will ensure regulatory compliance and ensuring that product quality, safety and consis- tency are not compromised. 2.4 The general text in the main part of these guidelines may be appli- ...
1.4.The key elements of the site qualification and validation programme should be clearly defined and documented in a validation master plan (VM 17、P) or equivalent document.工厂确认与验证程序的关键要素应当在验证总计划或等效文件中明确定义。1.5.The VMP or equivalent document should define the ...
简介 2Scope 范围 3Glossary 术语 4Relationship between validation and qualification 验证和确认之间的联系 5.Validation 5.1.Approaches to validation 验证方法 5.2.Scope of validation 验证范围 5Qualification 确认 6Calibration and verification 校准和核实 7Validation master plan 验证主计划 8Qualifi...