WHO TRS 1010, 2018 Annex 9

WHO TRS (Technical Report Series) 1010, 2018 Annex 9

Guidance on good practices for desk assessment of compliance with good manufacturing practices (GMP), good laboratory practices (GLP) and good clinical practices (GCP) for medical products regulatory decisions

Click on the titles below for complete guidelines

TABLE OF CONTENTS

Background

1. Introduction 

2. Aim and objectives of the guidance 

3. Scope of the guidance 

4. Glossary 

5. Essential elements of desk assessment 

5.1 High-level support and cooperation 

5.2 Commonality of quality management systems in inspectorates 

5.3 Convergent standards of good practices 

5.4 Reliability and accuracy of information 

5.5 Management tools to support consistent and objective assessment 

5.6 Risk-based assessment of available information 

5.7 Mutual trust and confidence among inspectorates 

5.8 Quality assurance of the desk assessment process 

5.9 Communication of assessment outcomes 

6. Sources of good information and related challenges 

6.1 Official websites with databases 

6.2 Authenticity of documents 

6.3 Failure to submit documentary evidence 

7. Submission and assessment of documentary evidence and information 

7.1 Submission of application for desk assessment and documentary evidence 

7.2 Assessment of documentary evidence and information 

7.3 General requirements for documents 

8. Regulatory actions and reporting of serious instances of noncompliance 

8.1 Communication and information exchange 

9. Responsibilities of the applicant

References and further reading 

Appendix 1: Model report format for desk assessment for finished pharmaceutical products and active pharmaceutical ingredient manufacturers 

Appendix 2: Model report format for desk assessment of quality control laboratories 3

Appendix 3: Model report format for desk assessment for contract research organizations and clinical trial sites

WHO TRS (Technical Report Series) 1010, 2018 Annex 9: