Qualification Services Tailored for Unique Requirements
At ProPharma Group, we apply current industry regulations to implement best practices that are tailored to meet your needs.
We use a risk-based approach to qualification activities by focusing on critical systems/parameters and emphasizing the leveraging of testing and documentation, as applicable.
- Evaluate the facility, equipment, processes, quality control, supporting utilities, control systems, automated systems, and analytical methods for product usage and criticality to the product and process.
- Determine the impact on quality using direct, indirect, or no impact designation.
- Scale activities aimed at ensuring GMP compliance and fitness for intended use are according to the level of complexity of the equipment (simple or complex).
- Assign critical systems (direct impact) a corresponding level of qualification.
- Assign indirect systems that are considered non-critical lower levels of verification, as applicable.
Flexible Approach for Each Client
Our service offering is flexible to ensure the level of testing and activities associated with each project meets industry standards as well as our clients’ quality program and requirements. It also is intended to be scaled appropriately to support various levels of risk and leverage pre-qualification activities. No two projects are considered alike; however, each project benefits from our team’s knowledge and expertise gained from years of experience and proven/successful project completion.