POINTS TO CONSIDER FOR COMMISSIONING AND QUALIFICATION OF MANUFACTURING FACILITIES AND EQUIPMENT - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 173

6. Department of Health and Human Services, U.S. Food and Drug Administration,
Code of Federal Regulation, Title 21 Chapters 210 and 211.
7. International Society for Pharmaceutical Engineering, ISPE Active Pharmaceutical
Ingredients Baseline ® Guide Second Edition, June 2007.
8. PDA Survey of Quality Risk Management Practices in the Pharmaceutical, Device &
Biotechnology Industries, PDA Journal of Pharmaceutical Science and Technology.
9. ASTM (American Society for Testing and Methodology) E2500-07, Standard Guide
for Standard Guide for Specification, Design, and Verification of Pharmaceutical and
Biopharmaceutical Manufacturing Systems and Equipment, page 2.
10. International Society for Pharmaceutical Engineering ISPE Baseline ® Pharmaceutical
Engineering Guide Series, Volume 5-Commissioning and Qualification, First Edition,
March 2001.
11. Department of Health and Human Services, U.S. Food and Drug Administration,
Guidance for Industry, Q9 Quality Risk Management, 2006, page 2.
12. ASTM (American Society for Testing and Methodology) E2500-07, Standard Guide
for Standard Guide for Specification, Design, and Verification of Pharmaceutical and
Biopharmaceutical Manufacturing Systems and Equipment, page 3.
13. Department of Health and Human Services, U.S. Food and Drug Administration,
Guidance for Industry on the General Principles of Process Validation, January 2011,
page 11.
14. Technical Report 44, Quality Risk Management of Aseptic Practices, PDA Journal
of Pharmaceutical Science and Technology, 2008 Supplement Volume 62, No. S-1.
15. Department of Health and Human Services, U.S. Food and Drug Administration,
Guidance for Industry on the General Principles of Process Validation, January 2011,
page 11.
16. ASTM (American Society for Testing and Methodology) E2500-07, Standard Guide
for Standard Guide for Specification, Design, and Verification of Pharmaceutical and
Biopharmaceutical Manufacturing Systems and Equipment, page 3.
17. Department of Health and Human Services, U.S. Food and Drug Administration,
Guidance for Industry on the General Principles of Process Validation, January 2011,
page 15.