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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.