Process Validation Services
A Lifecycle Approach That Is Structured, Risk-Based, and Effective
Prior to commercial manufacturing and distribution, FDA regulated manufacturers need to provide sufficient evidence that their production process will consistently meet predefined quality targets and performance expectations. Only a scientifically sound and robust process validation methodology assures continued safety, identity, strength, purity, and quality of biologic and pharmaceutical products. As you embark on the journey to demonstrate process compliance with FDA requirements, or if you discover the need to transition an outdated validation method to one that is a current and risk-based lifecycle approach, utilizing an experienced and knowledgeable partner to guide those efforts will pay huge dividends by enabling efficient decision making for process improvements.
ProPharma Group embraces a lifecycle approach to process validation that provides a structured, risk-based approach to ensure an effective control strategy for your process, applicable for products in development and in legacy products. Our approach uses data collected during the process qualification activities to determine when significant variability estimates have been achieved, providing confidence that the process is efficient, compliant, and productive. This methodology was initially designed to meet the FDA’s Process Validation: General Principles and Practices, and has since been updated to include EU Annex 15, WHO Process Validation Guide, China FDA Validation Guide, and concepts presented in ICHQ8 – 11.