From raw materials to finished goods, every contact point in the drug or device processing path creates a contamination risk — and a new chance to get hit with an FDA warning letter or product recall.
Ten companies have already run afoul of 21 CFR 211 cleaning and validation compliance. For one — Sumitomo Chemical — it was the design of a machine that’s been in widespread use since 1990.
Your facility could be next. That’s why it’s critical to clarify and comply with requirements for cleaning solvents, equipment design, training programs, validation and more.