ISPE Releases Cleaning Validation Guide

The International Society for Pharmaceutical Engineering (ISPE) has released new guidance on the cleaning validation lifecycle, written by a group of experts and reviewed by regulators and practitioners. The guide’s availability was announced in a Sept. 17, 2020 press release.

“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, in the press release. “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.”

Cleaning Validation Lifecycle—Applications, Methods, and Controls covers key areas, such as cleaning methodologies, determination of visual inspection limits, validation of testing and sampling methods, creation of cleaning validation acceptance criteria, and change management. The explanatory and hands-on guidance is available to be purchased online, along with ISPE’s other resources.

Source: ISPE​