$247 — Standard Tier

GMP & GDP Compliance Toolkit: FDA 21 CFR 820 Gap Assessment and Batch Records

GMP GDP Compliance Toolkit — 150+ point gap assessment, GDP qualification checklist, batch record template, deviation SOP, GMP training matrix, and inspection readiness assessment.

Get the Toolkit — $247

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What's Included

GMP Gap Assessment Checklist (21 CFR 820 QMSR + ISO 13485)
GDP Qualification and Distribution Controls Checklist
Batch/Lot Record Template (FDA 21 CFR 820.184 DHR)
Deviation and Out-of-Specification Investigation SOP
GMP Training Matrix and Competency Framework
GMP Regulatory Inspection Readiness Assessment

Benefits

150+ assessment points covering every QMSR and ISO 13485 requirement with risk ratings
DHR-compliant batch record template satisfies FDA 21 CFR 820.184 out of the box
Deviation SOP includes severity classification and CAPA initiation triggers
Inspection readiness assessment covers the 10 most-cited GMP deficiencies

Is This For You?

This toolkit is designed for teams facing these challenges:

GMP gaps identified during FDA inspection rather than before
Batch records missing required DHR elements under 21 CFR 820.184
Deviation investigation process inconsistent across manufacturing shifts
Inspection team not prepared for FDA investigator questions during facility walkthrough

Who This Is For

VP Operations responsible for GMP complianceQA managers building or upgrading manufacturing quality systemsRegulatory affairs leads preparing for FDA facility inspectionsContract manufacturers qualifying under a Quality Agreement

Frequently Asked Questions

Does this cover the new FDA QMSR?

Yes. The gap assessment is aligned with both legacy 21 CFR Part 820 and the updated Quality Management System Regulation (QMSR) that harmonizes FDA requirements with ISO 13485:2016.

Is this applicable to contract manufacturers?

Yes. The gap assessment and batch record templates apply to both finished device manufacturers and CMOs operating under a Quality Agreement.

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Ready to Get Started?

Download immediately after purchase. All templates are editable Word and Excel files.

Get the Toolkit — $247

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