OUTLINE

1. Introduction

2. Pancreas Collection and Pancreatin Production

3. Quality Control

4. Labeling

5. Certification and Documentation

6. Testing and Control of Adventitious Infectious Agents

   6.1 Overview

   6.2 Risk Assessment Strategies

   6.3 Identification of Relevant Virus Panel Test

   6.4 Virus Clearance by Manufacturing Process Steps

   6.5 Viral Testing

7. Characterization of Pancreatin

   7.1 Description and Physico-Chemical Properties

   7.2 Protein and Enzyme Contents

   7.2.1 Pancreatic Proteases

   7.2.2 Pancreatic Lipase and Colipase

   7.2.3 Pancreatic Phospholipase A2

   7.2.4 Pancreatic Amylase

8. Enzyme Activity Measurements

   8.1 Lipase Activity

   8.2 Protease Activity

   8.3 Amylase Activity

9. Appendix 1: Regulatory Bibliography

10. Appendix 2: Literature Bibliography