Equipment & Facilities Qualification Services

Commissioning and Pharmaceutical Qualification is a good engineering practice, which ensures that facilities, utilities, systems and equipment meet design, installation, operational, and performance requirements (IQ/OQ/PQ) prior to being turned over to the end-user. 

Compliance Team’s engineering experts are committed to helping clients with qualification services to support the full validation lifecycle. Whether your project involves: start-up, renovation, reviews/re-qualifications, or decommissioning, we apply risk-based thinking to fulfill regulatory expectations for the qualification of facility, utilities, systems, and equipment (FUSE).

Qualification is not just a regulatory expectation; it is good business practice. A profound understanding of the systems that support drug manufacturing of drug products ensures drug safety for patients and operators by identifying areas of misunderstanding and remediating through clear documentation and adequate training.  This method averts business liabilities and prevents costly production errors, saving your business tangible dollars over time.

Our approach aligns with industry best practices such as FDA validation guidances, ASTM E-2500, and  the ISPE Baseline Guide. We focus qualification efforts on those areas that have the greatest impact to your product/process, which increases efficiency and helps you save time and money.

Compliance Team has the know-how to provide qualification support for a wide range of systems, including the following:

  • Production systems (vessels, mixers, CIP, COP, columns & centrifuges)
  • Packaging and labeling equipment (fillers, labelers, printers & packaging lines)
  • Clean facilities (HVAC, BMS, Biosafety Cabinets & Isolators)
  • Clean utilities (e.g., nitrogen, compressed air, purified water &, clean steam)
  • Aseptic manufacturing equipment (e.g., autoclaves, lyophilizers & media fills)
  • Custom manufacturing equipment and control systems
  • Controlled storage equipment and facilities (e.g., refrigerators, freezers, incubators 7 warehouses)
  • Computerized systems (document management, change control, and automation)

 

 Let us facilitate a sensible, risk-based qualification approach for your operational systems.