WHO TRS (Technical Report Series) 929, 2005 Annex 4

WHO guidelines for sampling of pharmaceutical products and related materials - Annex 4

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TABLE OF CONTENTS

1. Introduction

1.1 General considerations 

1.2 Glossary 

1.3 Purpose of sampling 

1.4 Classes and types of pharmaceutical products and related materials 

1.5 Sampling facilities 

1.6 Responsibilities for sampling 

1.7 Health and safety 

2. Sampling process 

2.1 Preparation for sampling 

2.2 Sampling operation and precautions 

2.3 Storage and retention 

3. Regulatory issues 

3.1 Pharmaceutical inspections 

3.2 Surveillance programmes 

4. Sampling on receipt (for acceptance) 

4.1 Starting materials 

4.2 Intermediates in the manufacturing process and bulk pharmaceutical products 

4.3 Finished products 

4.4 Packaging materials (primary and secondary) 

5. Sampling plans for starting materials, packaging materials and finished products 

5.1 Starting materials 

5.2 Packaging materials 

5.3 Finished products 

Bibliography 

Appendix 1  Types of sampling tools 

Appendix 2  Sample collection form 

Appendix 3  Steps to be considered for inclusion in a standard operating procedure 

Appendix 4  Examples of types of containers used to store samples of starting materials and bulk products

Appendix 5  Examples of use of sampling plans n, p and r

1. Introduction

These guidelines are primarily intended for use by governmental organizations, such as drug regulatory authorities (including inspectorates), quality control laboratories and customs and police officials, but some of the general principles may also be appropriate for application by procurement agencies, manufacturers and customers.

WHO guidelines for sampling of pharmaceutical products and related materials - Annex 4