Cleaning Validation: Practical Compliance Solutions for Pharmaceutical Manufacturing, Volume 2

May 2017
PDA Item Number
Hardcover: 17289 | Digital: 18034
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This book complements Cleaning Validation: Practical Solutions for Pharmaceutical Manufacturing, Volume 1. It contains modifications and updates of the author`s monthly Cleaning Memos originally published from January 2005 through December 2008. In both volumes, each Cleaning Memo is presented as a chapter, with the chapters then organized by common topics rather than chronologically.

Book wrote in 2010.

Bundle Vol. 1, 2 & 3
Volume 1
Volume 2
Volume 3
Volume 4

Table of Contents

Table of Contents:

Click here to download>>>Detailed Table of Contents

  • General Topics
  • Special Situations
  • Residue Limits
  • Analytical Methods
  • Sampling
  • Sampling Recovery
  • Protocol Issues
  • Regulatory Issues
  • Microbial Issues
  • Appendix A: Shorthand Abbreviations for Expressing Limits
  • Appendix B: Acronyms Used in this Volume
  • Index
  • About the Authors

    About the Author

    Destin LeBlanc is a consultant at Cleaning Validation Technologies. He has extensive experience in product development and technical services for cleaning and antimicrobial applications. He is an international lecturer on contamination control and has written widely on cleaning validation topics including four volumes in the Cleaning Validation: Practical Compliance Solutions for Pharmaceutical Manufacturing series published by PDA and DHI. He is a member of PDA and ISPE and trains FDA personnel on cleaning validation. He is a graduate of the University of Michigan and the University of Iowa.