Cleaning Validation

ebook Practical Compliance Approaches for Pharmaceutical Manufacturing

By Destin A. LeBlanc

cover image of Cleaning Validation

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Pharmaceutical manufacturers and upper management are encouraged to meet the

challenges of the science-based and risk-based approaches to cleaning validation.

Using some of the principles and practices in this volume will help in designing a

more effective and efficient cleaning validation program.

Features

  • Timely coverage of cleaning validation for the pharmaceutical industry,

    a dynamic area in terms of health-based limits.

  • The author encourages pharmaceutical manufacturers, and particularly

    upper management, to meet the challenges of the science-based and riskbased

    approaches to cleaning validation.

  • Draws on the author's vast experience in the field of cleaning validation

    and hazardous materials.

  • Discusses EMA vs. ISPE on Cleaning Limits and revised Risk-MaPP for

    highly hazardous products in shared facilities.

  • A diverse list of topics from protocol limits for yeasts and molds to

    cleaning validation for homeopathic drug products.

  • Cleaning Validation