Pharmaceutical Commissioning and Qualification Case Studies
We Work with Some of the World’s Biggest Players — and the Next Big Names Entering the Game
ICQ has played an important role in the commissioning and qualification of manufacturing plants in the major life sciences hubs in the United States, including some of the world’s largest biomanufacturing facilities.
We also partner with early-to-market start-ups and emerging biopharma companies to help engineering and quality teams proactively anticipate and solve complex commissioning, qualification, and validation challenges.
ICQ Case Studies
Quality alignment after acquisition.
“ICQ performed an audit of our facilities, quality systems, and operational readiness and outlined a simple yet thorough executable and efficient strategy.”
Former Senior Director of Quality Assurance
It had to be perfect, the first time.
“ICQ produced extraordinary results by maintaining 100% right-first-time metrics, helping to end the consent decree and completing all assigned scope one month early.”
Former Sr. Director, Facilities & Engineering
Getting a new facility back on track.
“In the end, the biologics manufacturing facility was commissioned and qualified with no issues noted during the FDA inspection.”
Former Associate Director for Validation
Building success for contract manufacturing.
“I have never seen a firm as flexible, creative, or able to bring on additional staff as our needs evolve.”
VP Facilities & Engineering
Paragon (now Catalent)
Expertise and the staff to implement.
“ICQ was instrumental in the development of our CQV and AIQ programs, from providing leadership and guidance…to the actual generation of standard operating procedures.”
Former Senior Director of Validation
Shire (now Takeda)
Preparing a CDMO for COVID-19 vaccine manufacturing readiness.
“Without ICQ, we would not have met our timeline for facility readiness or been in a position to help with COVID vaccine production.”
Former Chief Quality and Regulatory Affairs Officer
Cell and Gene Therapy Contract Manufacturing Organization
Fast action gets COVID-19 testing lab ready.
“A heartfelt thanks for wrapping this up! The CLIA & GxP gap analysis are quite useful to us in understanding how to tackle future regulatory hurdles.”