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.
Key areas addressed in the Guide include:
Application of risk management
Adoption of a lifecycle approach for cleaning validation
Creation of cleaning validation acceptance criteria