WHO TRS 823, 1992 Annex 2

WHO TRS (Technical Report Series) 823, 1992 Annex 2

Provisional guidelines on the inspection of pharmaceutical manufacturers

Click on the any titles below for complete guidelines

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

WHO TRS (Technical Report Series) 823, 1992 Annex 2