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

17 September, 2020
Guide: Cleaning Validation Lifecycle - Applications, Methods, & Controls

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. 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.

Jose A. Caraballo

Head Audit Program Management Americas, Corporate Quality Audit and Inspections
Bayer US
Guide co-lead

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 Controlsavailable among ISPE’s other detailed education resources on a variety of industry topics.

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