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TABLE OF CONTENTS FOREWORD .........................................................................................................................................i ACKNOWLEDGEMENTS .......................................................................................................................... v

1

INTRODUCTION ......................................................................................................................... 1

    • 1.1

      Purpose and Scope..........................................................................................................................1

    • 1.2

      Principles Adopted .........................................................................................................................1

      • 1.2.1

        The Guide and its Use ..............................................................................................................1

      • 1.2.2

        Application ............................................................................................................................... 2

      • 1.2.3

        Quality System Standard ..........................................................................................................2

2 3

1.3

3.1 3.2

Document Structure........................................................................................................................ 2 DEFINITIONS .............................................................................................................................. 3

GENERAL GUIDANCE............................................................................................................... 3 Pharmaceutical Excipients.............................................................................................................. 3 Excipient GMP Implementation.....................................................................................................3

4

QUALITY MANAGEMENT SYSTEM- EXCIPIENT QUALITY SYSTEMS ..........................3

    • 4.1

      General Requirements ....................................................................................................................3

    • 4.2

      Documentation Requirements ........................................................................................................4

      • 4.2.1

        General ..................................................................................................................................... 4

      • 4.2.2

        Quality Manual......................................................................................................................... 4

      • 4.2.3

        Control of Documents ..............................................................................................................4

      • 4.2.4

        Control of Records ...................................................................................................................4

    • 4.3

      Change Control............................................................................................................................... 5

5

5.1 5.2 5.3 5.4

MANAGEMENT RESPONSIBILITY .........................................................................................5 Management Commitment .............................................................................................................5 Customer Focus .............................................................................................................................. 5 Quality Policy................................................................................................................................. 6 Planning..........................................................................................................................................6

      • 5.4.1

        Quality Objectives .................................................................................................................... 6

      • 5.4.2

        Quality Management System Planning ....................................................................................6

R e s p o n s i b i l i t y , A u t h o r i t y a n d C o m m u n i c a t i o n . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.5 6 Responsibility and Authority....................................................................................................6 Management Representative ....................................................................................................7 Internal Communication ........................................................................................................... 7 5.5.1 5.5.2 5.5.3

    • 5.6

      Management Review ...................................................................................................................... 7

      • 5.6.1

        General ..................................................................................................................................... 7

      • 5.6.2

        Review Input ............................................................................................................................7

      • 5.6.3

        Review Output.......................................................................................................................... 7

6.2.1 6.2.2

General ..................................................................................................................................... 8 Competence, Awareness and Training .....................................................................................8

6.2.3

Personnel Hygiene.................................................................................................................... 8

    • 6.3

      Infrastructure .................................................................................................................................. 8

      • 6.3.1

        Buildings and Facilities............................................................................................................9

      • 6.3.2

        Equipment ................................................................................................................................ 9

        • 6.3.2.1

          Equipment Construction...................................................................................................... 9

        • 6.3.2.2

          Equipment Maintenance...................................................................................................... 9

RESOURCE MANAGEMENT ....................................................................................................7 Provision of Resources...................................................................................................................7 Human Resources ........................................................................................................................... 8

6

6.1 6.2

Copyright © 2006 The International Pharmaceutical Excipients Council and Copyright © 2006 Pharmaceutical Quality Group

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