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WHO guidelines on the transfer of technologyin pharmaceutical manufacturing

WHO制藥生產(chǎn)技術(shù)轉(zhuǎn)移指南

Background

背景

1. Introduction

介紹

2. Scope

范圍

3. Glossary

術(shù)語(yǔ)

4. Due diligence and gap assessments

盡職調(diào)查和差距評(píng)估

5. Organization and management

組織和管理

6. Quality management and quality risk management

質(zhì)量管理和質(zhì)量風(fēng)險(xiǎn)管理 

7. Documentation

文件

8. Premises

廠房

9. Equipment and instruments

設(shè)備和儀器

10. Qualification and validation

確認(rèn)與驗(yàn)證

11. Product life cycle and project management principles

產(chǎn)品生命周期和項(xiàng)目管理原則

12. Phases of a technology transfer project

技術(shù)轉(zhuǎn)移項(xiàng)目階段

Phase I: Project initiation

階段1：項(xiàng)目啟動(dòng)

Phase II: Project proposal

階段2：項(xiàng)目計(jì)劃

• Establishing a team

• 建立團(tuán)隊(duì)

• Risk assessment

• 風(fēng)險(xiǎn)評(píng)估

• Project plan

• 項(xiàng)目計(jì)劃

• Control strategy

• 控制策略

Phase III: Project transfer

階段3項(xiàng)目轉(zhuǎn)移

• Production: transfer (processing, packaging)

• 生產(chǎn)：轉(zhuǎn)移（工藝、包裝）

• Starting materials

• 起始物料

• Active pharmaceutical ingredients

• 活性藥物成分

• Excipients

• 輔料

• Information on process and finished pharmaceutical products information

• 關(guān)于工藝和藥物成品的信息

• Packaging

• 包裝

• Quality control: analytical method transfer

• 質(zhì)量控制：分析方法轉(zhuǎn)移

• Cleaning

• 清潔

Phase IV: Project review

階段4：項(xiàng)目回顧

References