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    Downloadable Publications from ISPE

      Product Format Price Order   Ships In...  
    1. ISPE Baseline Guide: Volume 1 - Active Pharmaceutical Ingredients (Second Edition) More Info
    2007
     
    Secure PDF $415.00 Buy SPDF Download
    Printed Edition $415.00 Buy H 3-5 Days

    2. GAMP Good Practice Guide: Electronic Data Archiving More Info
    2007
     
    Secure PDF $215.00 Buy SPDF Download
    Printed Edition $215.00 Buy H 3-5 Days

    3. ISPE Good Practice Guide: Development of Investigational Therapeutic Biological Products More Info
    2007
     
    Secure PDF $215.00 Buy SPDF Download
    Printed Edition $215.00 Buy H 3-5 Days

    4. ISPE Good Practice Guide: Commissioning and Qualification of Pharmaceutical Water and Steam Systems More Info
    2007
     
    Secure PDF $215.00 Buy SPDF Download
    Printed Edition $215.00 Buy H 3-5 Days

    5. Comprehensive Guide to Clinical Materials: A Handbook for Training Clinical Materials Professionals More Info
    2006
     
    Secure PDF $145.00 Buy SPDF Download
    Printed Edition $145.00 Buy H 3-5 Days

    6. ISPE GAMP Good Practice Guide: Global Information Systems Control and Compliance More Info
    2005
     
    Secure PDF $215.00 Buy SPDF Download
    Printed Edition $215.00 Buy H 3-5 Days

    7. ISPE GAMP Good Practice Guide: IT Infrastructure Control and Compliance More Info
    2005
     
    Secure PDF $215.00 Buy SPDF Download
    Printed Edition $215.00 Buy H 3-5 Days

    8. ISPE GAMP: Guide for Validation of Automated Systems More Info
    2001 REPLACED by GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems

    GAMP 4, Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems
     
    This item is not available from Techstreet.

    9. GAMP Good Practice Guide: Validation of Laboratory Computerized Systems More Info
    2005
     
    Secure PDF $145.00 Buy SPDF Download
    Printed Edition $145.00 Buy H 3-5 Days

    10. GAMP Good Practice Guide: A Risk-Based Approach to Compliant Electronic Records and Signatures More Info
    2005
     
    Secure PDF $215.00 Buy SPDF Download
    Printed Edition $215.00 Buy H 3-5 Days

    11. GAMP Good Practice Guide: Calibration Management More Info
    2001
     
    Secure PDF $145.00 Buy SPDF Download
    Printed Edition $145.00 Buy H 3-5 Days

    12. GAMP Good Practice Guide: Validation of Process Control Systems More Info
    2003
     
    Secure PDF $215.00 Buy SPDF Download
    Printed Edition $215.00 Buy H 3-5 Days

    13. ISPE Good Practice Guide: Assessing the Particulate Containment Performance of Pharmaceutical Equipment More Info
    2005
     
    Secure PDF $215.00 Buy SPDF Download
    Printed Edition $215.00 Buy H 3-5 Days

    14. ISPE Good Practice Guide: Technology Transfer More Info
    2003
     
    Secure PDF $215.00 Buy SPDF Download
    Printed Edition $215.00 Buy H 3-5 Days

    15. ISPE Baseline Guide: Volume 1 - Bulk Pharmaceutical Chemicals More Info
    1996
     
    This item is not available from Techstreet.

    16. ISPE Baseline Guide: Volume 2 - Oral Solid Dosage Forms ***REMOVED FROM SALE PENDING NEW REVISION More Info
    1998
     
    This item is not available from Techstreet.

    17. ISPE Baseline Guide: Volume 3 - Sterile Manufacturing Facilities More Info
    1999
     
    Secure PDF $415.00 Buy SPDF Download
    Printed Edition $415.00 Buy H 3-5 Days

    18. ISPE Baseline Guide: Volume 4 - Water and Steam Systems More Info
    2001
     
    Secure PDF $415.00 Buy SPDF Download
    Printed Edition $415.00 Buy H 3-5 Days

    19. ISPE Baseline Guide: Volume 5 - Commissioning and Qualification More Info
    2001
     
    Secure PDF $415.00 Buy SPDF Download
    Softcover $415.00 Buy SC 3-5 Days

    20. ISPE Baseline Guide: Volume 6 - Biopharmaceutical Manufacturing Facilities More Info
    2004
     
    Secure PDF $415.00 Buy SPDF Download
    Printed Edition $415.00 Buy H 3-5 Days

    21. ISPE Baseline Guide: Volumes 1-6 Set More Info
    2004
     
    This item is not available from Techstreet.