Stability testing of api and finished pharmaceutical products

Stability testing of (api) active pharmaceutical ingredients and finished pharmaceutical products - Annex 10

Introduction and background

The guidance on Stability testing of active pharmaceutical ingredients and finished pharmaceutical products was published as Annex 2 in the World Health Organization (WHO) Technical Report Series, No. 953, 2009 (1).

The aim of these regulatory guidelines is to outline the core stability data package required for registration of active pharmaceutical ingredients (APIs) and finished pharmaceutical products (FPPs), replacing the previous WHO guidelines in this area. The guidelines cross-refer to the series of related documents published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) (2) and other WHO guidelines.

Click on the titles below for complete guidelines

TABLE OF CONTENTS

1. Introduction 

1.1 Objectives of these guidelines 

1.2 Scope of these guidelines 

1.3 General principles 

2. Guidelines 

2.1 Active pharmaceutical ingredient 

2.1.1 General 

2.1.2 Stress testing 

2.1.3 Selection of batches 

2.1.4 Container-closure system 

2.1.5 Specification 

2.1.6 Testing frequency 

2.1.7 Storage conditions 

2.1.8 Stability commitments 

2.1.9 Evaluation 

2.1.10 Statements and labelling 

2.1.11 Ongoing stability studies 

2.2 Finished pharmaceutical product 

2.2.1 General 

2.2.2 Stress testing 

2.2.3 Selection of batches 

2.2.4 Container-closure system 

2.2.5 Specification 

2.2.6 Testing frequency

2.2.7 Storage conditions 

2.2.8 Stability commitments 

2.2.9 Evaluation 

2.2.10 Statements and labelling 

2.2.11 In-use and hold time stability 

2.2.12 Variations 

2.2.13 Ongoing stability studies 

3. Glossary 

References 

Appendix 1  Examples of testing parameters 

Appendix 2  Recommended labelling statements 

Appendix 3  Interpretation of storage statements for products approved in climatic zone II when the products are to be distributed in zone IV

Stability testing of api and finished pharmaceutical products