What would an FDA investigator find at your pet food plant?
24 yes/no questions mapped to 21 CFR Part 507 — hazard analysis, preventive controls, CGMP, supply-chain controls, testing and verification. Every box you can't check is a gap an investigator can find.
Six sections. Zero fluff.
Every check is a yes/no question tied to a real requirement — the same questions we ask in week one of a readiness assessment.
Documentation & batch records
5 checks — master records, batch documentation, specifications, lab records, retention. Mapped to 21 CFR Part 111 / 117.
Facility & equipment qualification
5 checks — IQ/OQ/PQ coverage, calibration, environmental controls, segregation, water systems.
Quality systems & CAPA
5 checks — quality program ownership, deviation investigations, CAPA closure, complaint files, management review.
Data integrity & Part 11
5 checks — system validation, audit trails, access control, e-signatures, backup and restore testing.
Supplier control
4 checks — identity testing, supplier qualification, COA verification, rejected-material handling. Mapped to Part 111 / 117 / 507.
Cleaning validation
4 checks — validated cleaning procedures, residue limits, changeover control, cleaning records.
Get the checklist.
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Rather talk it through with a human?
Start with a free GMP readiness call — we’ll walk through your top 3 GMP risks and give you an honest fit assessment. Confidential, no pressure.