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                   Report Types

  cGMP Text Reports               GLP Text Reports

  Title Page                                           Title Page

   List of Tables                                     GLP Compliance Statement

   List of Figures                                    QA Compliance Statement

   1.0 Abbreviations                               Signature & Approval Page

   2.0 Summary                                      List of Tables

   3.0 Materials & Methods                    List of Figures

   4.0 Calculations                                  1.0 Abbreviations

   5.0 Results (tabular & graphic)            2.0 Summary

   6.0 Conclusions                                  3.0 Materials & Methods

   *7.0 Rep. Chromatograms/Spectra     4.0 Calculations

   8.0 Protocol Deviations                       5.0 Results (tabular & graphic)

   References                                          6.0 Conclusions

   QA Compliance Statement                  *7.0 Rep. Chromatogram/Spectra

   Signature & Approval Page                 8.0 Protocol Deviations

   Attachments/Appendices                     Attachments/Appendices

 

   cGMP Data Reports               R&D Reports

   Title Page                                            Title Page

    Tabular Analytical data                        Summary/Conclusions

    *Rep. Chromatograms/Spectra            Signature & Approval Page

    QA Compliance Statement                   *Rep. Chromatograms/Spectra

    Signature & Approval Page                  **Analytical Data

 

*Chromatograms/Spectra may not apply to all reports

**Analytical Data may not apply to all R&D reports

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