Home / FDA readiness / USP water system review
USP purified water system review
Know your water system is in control.
For water-based OTC, cosmetics and personal care products, purified water is a critical raw material. This review looks at how your system is designed, run, monitored and trended, and gives you written findings and a prioritized plan.
Who this is for
When water is the question.
Aging or modified systems
The system has been changed, extended or patched since it was validated.
Excursions or rising trends
Alert and action limit excursions, or microbial results drifting the wrong way.
Before an inspection or audit
You want an independent check of the system an investigator is likely to ask about.
What the engagement includes
From the loop to the trend chart.
- A walkdown of the system against current drawings (P&IDs), noting dead legs and changes since validation
- Review of sanitization, maintenance and change control
- Sampling plan, alert and action limits, and how excursions are investigated
- Trend review of microbial and chemical results over a period you choose
- Validation and qualification status of the system
- Written findings and a prioritized plan
Who you work with
Kobe Ofori-atta, founder.
“What set Kobe apart was technical rigor combined with sound judgment. He was the FDA point of contact for the pilot plant in Piscataway. He doesn’t stop at diagnosing a problem; he builds the system that keeps it fixed.”
Relevant experience
- Primary site FDA contact; hosted FDA inspections and quality audits, with zero major findings.
- Process engineering and compliance (2016–19): equipment and utility validation, GMP and EHS.
- Led a USP purified water system modernization and built a 24/7 real-time operational dashboard.
- Plant manager of a global R&D pilot manufacturing center (2021–25), supporting 350+ scientists.
Roles held at Colgate-Palmolive before founding Claraxis Group. Full background →
Questions
Answered.
What do you review the system against?
The requirements in the USP Purified Water monograph, your own specifications and procedures, and the system’s validation documents.
Does it need to be on-site?
The walkdown is best done on-site. Data, trend and document review can be done remotely.
Do you redesign the system?
The review flags design and control issues and recommends what to change. Detailed engineering stays with your engineering team or contractor.
What does it cost and how long does it take?
A fixed fee of [PRICE]; typical duration [DURATION].
Is this legal or regulatory advice?
No. Claraxis provides operational and quality systems support alongside your quality unit. Bring in regulatory counsel where legal judgment is needed, especially if a warning letter is likely.
The FDA Watch brief
Get this in your inbox every month.
What FDA cited, and the one thing to fix. 3-minute read, free.
Start with the real challenge.
A 30-minute call, then a written scope before any commitment. Kobe replies personally within one business day.