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序號

機構(gòu)

參考文件

主要內(nèi)容

參考鏈接

1

EU

《歐盟檢查和信息交換程序匯編》（Compilation of Community Procedures）：是歐盟的一份官方參考文件，匯集了歐盟/歐洲經(jīng)濟區(qū)的藥品生產(chǎn)質(zhì)量管理規(guī)范/藥品流通質(zhì)量管理規(guī)范檢查機構(gòu)、歐洲藥品管理局（EMA）和歐盟委員會在監(jiān)管檢查的協(xié)調(diào)與執(zhí)行中所使用的所有統(tǒng)一程序、模板和指南。它包含了歐盟檢查機構(gòu)執(zhí)行檢查的相關(guān)程序。

Procedures

1) Introduction to the Compilation of Union procedures on inspections and exchange of information

2) Quality systems framework for Good Manufacturing Practice (GMP) inspectorates

3) Management and classification of reports of suspected quality defects in medicinal products and risk-based decision-making

4) Management of rapid alerts arising from quality defects risk assessment

5) Conduct of inspections of pharmaceutical manufacturers or importers

6) Outline of a procedure for co-ordinating the verification of the GMP status of manufacturers in third countries

7) Guideline on training and qualifications of good manufacturing practice (GMP) inspectors

8) Guidance on the occasions when it is appropriate for competent authorities to conduct inspections at the premises of manufacturers, importers and distributors of active substances and manufacturers or importers of excipients used as starting materials

9) The issue and update of good manufacturing practice (GMP) certificates

10) A model for risk based planning for inspections of pharmaceutical manufacturers

11) Procedure for dealing with serious good manufacturing practice (GMP) non-compliance information originating from third country authorities or international organisations

12) Procedure for dealing with serious good manufacturing practice (GMP) non-compliance requiring co-ordinated measures to protect public or animal health

13) Guideline on training and qualification of inspectors performing inspections of wholesale distributors

14) Good distribution practice (GDP) inspection procedure

15) The issue and update of good distribution practice (GDP) certificates

16) Co-ordinating good manufacturing practice (GMP) inspections for centrally authorised products

17) Procedure for compliance management

18) EU/EEA programme for maintenance of equivalence in supervision of good manufacturing practice compliance of pharmaceutical companies

Compilation of Union procedures on inspections and exchange of information | European Medicines Agency (EMA)

2

FDA

《檢查操作手冊》-2025（Investigations Operations Manual，簡稱IOM）FDA發(fā)布的用于指導(dǎo)其檢查員開展現(xiàn)場調(diào)查活動的官方操作指南。

1) Chapter 1 - Administration 

2) Chapter 2 - Notes, Records and Information 

3) Chapter 3 - Regulatory 

4) Chapter 4 - Sampling  

5) Chapter 5 - Inspections 

6) Chapter 6 - Imports

7) Chapter 7 - Recall Activities

8) Chapter 8 - Investigations

9) Chapter 9 - Public Health Collaboration

10) Chapter 10 – Safety

11) Appendix

Investigations Operations Manual | FDA