Compliance and Cost Competitiveness


Process Validation

Process-ValidationValidation Edge, LLC specializes in developing SOP's and protocols for the Process Validation based upon the identification, monitoring and control of Critical Quality Attributes (CQA's) and Critical Process Parameters (CPP's).

Process Validation Master Plans and SOP's are developed to comply with the FDA's current Process Validation Guidance (2011). We assist our clients with transitioning from traditional Process Validation practices to the Lifecycle Approach ( Process Validation - Stage 1, 2 and 3) as required by the current Process Validation Guidance.

Our Process Validation protocols are based on the Quality by Design (QbD) approach. The objective is to achieve higher level of compliance, while simultaneously reducing the operating costs by improving efficiency, reliability and reproducibility of the manufacturing processes.