Jared Clark, CPGP, Principal Consultant at Certify Consulting and theGMPconsultant.com, runs a structured 90-day plan for dietary supplement manufacturers: gap analysis against 21 CFR Part 111, documentation repair, staff training, and a full mock FDA inspection.
The engagement opens with a full facility walkthrough and document inventory, followed by a gap assessment scored against every applicable 21 CFR Part 111 subpart — specifications, incoming material testing, master manufacturing records, batch production records, laboratory operations, and complaint handling. Mock interviews with key staff (production, QA, and warehouse) reveal whether the documented procedures match what people actually do on the floor, which is often the real gap.
With the gap list prioritized by audit risk, month 2 closes the highest-priority items first — typically specification documentation, batch record accuracy, and out-of-specification (OOS) handling procedures. Employee training records are updated to reflect any corrected procedures, and the records room is reorganized so an auditor can locate any document within minutes, not hours.
The final month runs a full mock FDA-style inspection — document review, facility walkthrough, and employee interviews conducted the way an actual FDA investigator would run them. The team who will escort real auditors is trained on Day 1 protocol: what to say, what not to volunteer, and how to retrieve requested records efficiently. By the end of week 12, the facility has been through a genuine dress rehearsal, not a paperwork review.
This 90-day framework covers both FDA inspections and third-party certifications (NSF 455-2, USP, UL/GMP). See the full GMP certification guide for the complete methodology.