WHO TRS 996, 2016 Annex 1

WHO TRS (Technical Report Series) 996, 2016 Annex 1

 WHO Good Pharmacopoeial Practices | Annex1

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TABLE OF CONTENTS

1. Background 

2. Purpose and scope of good pharmacopoeial practices 

3. Glossary 

4. Benefits of good pharmacopoeial practices 

5. Implementation 

6. Monograph development 

6.1 General considerations 

6.1.1 Adoption of pharmacopoeial standards 

6.1.2 Open and transparent process 

6.1.3 Harmonization 

6.1.4 Legal recognition 

6.1.5 Compliance with a pharmacopoeial monograph 

6.1.6 Analytical requirements 

6.1.7 Acceptance criteria 

6.2 Technical guidance 

6.2.1 Monographs for pharmaceutical substances 

6.2.2 Monographs for finished pharmaceutical products 

7. Analytical test procedures and methods

WHO TRS (Technical Report Series) 996, 2016 Annex 1