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        • 8.2.4.2

          Finished Excipient Testing and Release............................................................................21

        • 8.2.4.3

          Out-of-Specification Test Results .....................................................................................21

        • 8.2.4.4

          Retained Samples ..............................................................................................................21

        • 8.2.4.5

          Certificates of Analysis .....................................................................................................21

        • 8.2.4.6

          Impurities .......................................................................................................................... 21

        • 8.2.4.7

          Stability ............................................................................................................................. 22

        • 8.2.4.8

          Expiry/Retest Periods........................................................................................................ 22

    • 8.3

      Control of Nonconforming Product..............................................................................................22

      • 8.3.1

        Reprocessing .......................................................................................................................... 23

      • 8.3.2

        Reworking .............................................................................................................................. 23

      • 8.3.3

        Returned Excipients ...............................................................................................................23

    • 8.4

      Analysis of Data ...........................................................................................................................23

    • 8.5

      Improvement................................................................................................................................. 24

      • 8.5.1

        Continual Improvement.......................................................................................................... 24

      • 8.5.2

        Corrective Action ...................................................................................................................24

      • 8.5.3

        Preventive Action ................................................................................................................... 24

APPENDIX A

AUDITING CONSIDERATIONS............................................................................... 25

A1. A2.

Introduction .................................................................................................................................. 25 GMP Principles ............................................................................................................................25

A2.1 A2.2 A2.3 A2.4

Control of impurities and contamination................................................................................25 Excipient properties and functionality ...................................................................................25 Consistency of manufacture and change control....................................................................26 Traceability............................................................................................................................. 26

A3. A4. A5. A6.

Application of GMP Principles ....................................................................................................26 General Auditing Considerations .................................................................................................26 Audit Check Points.......................................................................................................................27 Documentation and Record Review.............................................................................................28

APPENDIX B APPENDIX C

DEFINITIONS AND GLOSSARY .............................................................................30 BIBLIOGRAPHY ........................................................................................................ 34

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

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