ISPE releases guide to cleaning validation lifecycle

The US not-for-profit organisation is publishing the guide in light of changing expectations for cleaning validation

The International Society for Pharmaceutical Engineering (ISPE) announced the release of a publication entitled '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 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.”

The guide addresses key topics around the cleaning validation life cycle including applicatoin of risk management, cleaning methodologies, the creation of leaning validation acceptance criteria and change management. It also covers equipment issues and challenges, determination of visual inspection limits and the adoption of a lifecycle approach for cleaning validation.

The guide, along with ISPE's other education resources on various industry topics, is available for purchase at the company's website.

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