C.3.3.7 Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities

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Table of Contents

 

Executive summary

 

1. Introduction (background)

 

2. Scope

 

3. Legal basis

 

4. Determination of health based exposure limits

 

5. Specific considerations

 

6. Reporting of the PDE determination strategy

 

7. Implementation

 

8. Definitions

 

References:

 

Annex