Qualification

Equipment & Facilities

QSP offers a wide range of solutions that satisfy the FDA’s expectations for equipment qualification. The engineering and science professionals at QSP are well versed in GMP requirements as well as industry practices.Our approach is built upon a strong technical understanding of the equipment being qualified and our applied expertise to achieve the most viable solution for each validation.

Whenever practical, QSP employs a risk-based approach to equipment qualification and can use this technique to reduce costs and time to completion. QSP works closely with your team to write qualifications that ensure equipment is designed and installed according to your process requirements. We are proficient at writing and executing operational qualifications that confirm and challenge established tolerances. Our staff has applied experience that is well suited for developing and conducting performance qualifications to demonstrate that equipment functions consistently and meets process demands.

Validation is necessary to clear FDA compliance hurdles, but a strong validation program can do much more. Improvements to process efficiency and lower costs can be achieved by optimizing your equipment and production processes. To get the most out of these techniques and stay on top of FDA and international regulatory expectations, you need proven strategies for your validation program.

Although not necessarily required for every project, our team is experienced in developing and executing:

• Validation Master Plans (VMP)
• User Requirements Specifications (URS)
• Functional Requirements Specifications (FRS)
• Risk Assessments (RA)
• Commissioning including Factory & Site Acceptance Tests