ISPE Publishes ISPE Guide: Cleaning Validation Lifecycle - Applications, Methods, and Controls

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The Guide was written by a group of experts and reviewed by regulators and practitioners in the field, delivering a comprehensive explanation and hands-on guidance for the cleaning validation lifecycle

ISPE Guide: Cleaning Validation Lifecycle - Applications, Methods, and Controls
This Guide was written by a group of experts and reviewed by regulators and practitioners in the field. It is a great resource for understanding and applying the principles for compliant cleaning programs, including how-to steps and examples.

The International Society for Pharmaceutical Engineering (ISPE) announced the release of its latest Guide, ISPE Guide: Cleaning Validation Lifecycle - Applications, Methods, and Controls. The Guide was written by a group of experts and reviewed by regulators and practitioners in the field, delivering a comprehensive explanation and hands-on guidance for the cleaning validation lifecycle.

“This Guide provides the requirements, principles, and practices for cleaning validation in a single volume and is the first of its kind in the industry,” said Jose Caraballo, Head Audit Program Management Americas, Corporate Quality Audit and Inspections, Bayer US, Guide co-lead. “We decided to address the topic because the expectations for cleaning validation are changing. This Guide was written by a group of experts and reviewed by regulators and practitioners in the field. It is a great resource for understanding and applying the principles for compliant cleaning programs, including how-to steps and examples.”

Key areas addressed in the Guide include:

  • Application of risk management
  • Adoption of a lifecycle approach for cleaning validation
  • Cleaning methodologies
  • Creation of cleaning validation acceptance criteria
  • Determination of visual inspection limits
  • Calculation and justification of residue limits
  • Validation of testing and sampling methods
  • Equipment issues and challenges
  • Change Management

Purchase the ISPE Guide: Cleaning Validation Lifecycle - Applications, Methods, and Controls online, available at ISPE.org/Publications/Guidance-Documents, among ISPE’s other detailed education resources on a variety of industry topics.

About ISPE
The International Society for Pharmaceutical Engineering (ISPE) is the world’s largest not-for-profit association serving its members through leading scientific, technical, and regulatory advancement across the entire pharmaceutical lifecycle. The 18,500 members of ISPE are building solutions in the development and manufacture of safe, effective pharmaceutical and biologic medicines, and medical delivery devices in more than 90 countries around the world. Founded in 1980, ISPE has its worldwide headquarters and training center in North Bethesda, Maryland, USA, and its operations center in Tampa, Florida, USA. Visit ISPE.org for more information.

For more information, contact:
Amy Henry
Marketing Communications Manager
International Society for Pharmaceutical Engineering (ISPE)
Email: ahenry@ispe.org
ISPE.org

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ISPE
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