NAFDAC -Gmp Guidelines for pharma products

 TABLE OF CONTENTS

NAFDAC GOOD MANUFACTURING PRACTICE GUIDELINES FOR PHARMACEUTICAL PRODUCTS 2016 3

INTRODUCTION............................................................................................... 6

PHARMACEUTICAL QUALITY SYSTEM.................................................. 8

PERSONNEL.......................................................................................................17

PREMISES AND EQUIPMENT...................................................................... 23

QUALIFICATION AND VALIDATION....................................................... 33

DOCUMENTATION......................................................................................... 41

PRODUCTION.................................................................................................... 62

MATERIALS MANAGEMENT....................................................................... 73

QUALITY CONTROL....................................................................................... 83

CONTRACT MANUFACTURE AND ANALYSIS...................................... 95

COMPLAINTS AND PRODUCT RECALL ................................................ 97

SELF-INSPECTION............................................................................................100

REFERENCES......................................................................................................100

GLOSSARY............................................................................................................103