Provisional guidelines on the inspection of pharmaceutical

Provisional guidelines on the inspection of pharmaceutical manufacturers

Annex 2

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TABLE OF CONTENTS

Introduction 

The role of the inspector

The inspection process

Routine inspection

Concise inspection

Follow-up inspection (Reassessment or Reinspection)

Special inspection

Quality systems review

Frequency and duration of inspections

Preparing for the inspection

Conduct

Report

Regulatory actions

References

Appendix 1- Recommended publications and documents

Appendix 2- Form and content of the inspector's report

Provisional guidelines on the inspection of pharmaceutical manufacturers