Validation Edge, LLC follows the Lifecycle Approach to develop cleaning validation programs aligned with the FDA's 21st Century cGMP Initiative. The objective is to enhance safety of the patients, who are the ultimate users of the products impacted by cleaning validation.
We develop cleaning programs by considering all critical factors like the nature and concentration of cleaning agents, and the mechanisms of controlling critical steps in cleaning procedures.
Sources, extent and controls over any type of variability are clearly identified and documented.
We develop scientifically sound cleaning programs prior to preparing the cleaning validation protocols. The emphasis is on developing a thorough understanding about the cleaning processes to ensure that the cleaning validation is effective and compliant.
We also perform Gap Analysis on cleaning validation programs and develop the Remedial Action Plans to enhance the level of efficiency, effectiveness and compliance.