Process validation is defined as establishing documented evidence that a specific process will reliably and consistently produce a product that meets its predetermined specifications and quality attributes. Processes could encompass manufacturing, filling, sterilization, and packaging within the FDA regulated pharmaceutical, biotechnology, API and medical device industries. ProPharma Group employees have experience validating processes in all aspects of the FDA regulated industries.

We can review your development reports to assist in the determination of critical process parameters and quality attributes, and use this review to develop scientifically justified validation plans, which demonstrate consistency and reliability in processing. We can also assist you in developing statistically justified in-process and finished product sampling strategies. Knowledge of the critical processing steps, quality attributes and sampling strategies allows our process validation engineers to challenge the robustness of the process during the development and execution of the validation studies.