Free Tools & Downloads
Download the free GMP Audit Preparation Guide — a 90-day, week-by-week plan for getting your facility ready for FDA and third-party GMP inspections.
The most common thing quality managers say before an audit is: "We think we're compliant, but we're not sure." This guide replaces that uncertainty with a concrete 90-day plan — what to assess, fix, and practice, week by week, before FDA or a third-party auditor walks through the door.
Document inventory, gap assessment against 21 CFR Part 111, mock interviews, facility walk-through checklist
High-priority gap closure (identity testing, specifications, CAPA), training records, records-room organization
Full mock inspection, escort team roles and rules, final pre-audit checklist
A one-page table of every document an investigator will request, where it lives, and who owns it
How FDA's risk-based, unannounced inspections differ from scheduled NSF 455-2, USP, and UL GMP audits
The documents NSF reviews and the questions their auditors actually ask
Prepared by Jared Clark — CPGP, CQA, RAC. 200+ manufacturers guided to GMP certification with a 100% first-time audit pass rate.
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A 90-day, week-by-week preparation plan: Month 1 covers document inventory, gap assessment, mock interviews, and a facility walk-through; Month 2 covers gap closure and training; Month 3 covers a full mock inspection, escort team training, and a final pre-audit check — plus an inspection-day quick reference and NSF/ANSI 455-2 preparation.
Yes — completely free. We ask for your name, email, and company so we can deliver the guide and provide context-specific follow-up. There is no obligation to purchase consulting services.
Both. The guide explains how FDA's risk-based, typically unannounced inspections differ from scheduled third-party audits (NSF/ANSI 455-2, USP, UL GMP), and the 90-day plan prepares your facility for either one.
Schedule a free consultation and we'll walk through where your facility stands, which gaps are actually on your critical path, and a realistic timeline to audit-ready.