GMP & GDP Compliance Toolkit
Gap assessment, batch records, deviation SOPs, training matrices, and inspection readiness — everything you need before FDA walks through the door.
What You Get
GMP Gap Assessment Checklist (21 CFR 820 + ISO 13485)
Comprehensive GMP gap assessment covering FDA 21 CFR Part 820 QMSR and ISO 13485:2016 requirements. 150+ assessment points organized by QMS element: management responsibility, resource management, product realization, measurement/analysis/improvement. Each gap includes risk rating and remediation guidance for prioritizing corrective actions.
GDP Qualification and Distribution Controls Checklist
Good Distribution Practice qualification checklist for medical device distributors and logistics providers. Covers storage condition qualification, temperature monitoring, handling procedures, chain of custody documentation, returns and recalls process, and the supplier qualification requirements that apply to your distribution network under FDA and EU MDR.
Batch/Lot Record Template (FDA 21 CFR 820.184)
Master batch record template aligned with FDA Device History Record (DHR) requirements under 21 CFR 820.184. Covers lot identification, manufacturing dates, quantity manufactured and released, acceptance records, primary device identification label, labeling, and device inspection/test records. Designed as a controlled document within your QMS.
Deviation and Out-of-Specification (OOS) Investigation SOP
Complete deviation and OOS investigation procedure covering identification, containment, investigation, root cause analysis, impact assessment, and CAPA initiation triggers. Aligned with FDA 21 CFR 820.90 (nonconforming product) and ISO 13485 Section 8.3. Includes severity classification matrix and management escalation thresholds.
GMP Training Matrix and Competency Framework
Role-based GMP training matrix covering all personnel involved in manufacturing, testing, and distribution. Maps training requirements to job functions, GMP elements, and document control versions. Includes competency assessment criteria, training frequency requirements, and the documentation format FDA investigators review during inspections.
GMP Regulatory Inspection Readiness Assessment
Pre-inspection readiness assessment for FDA and notified body GMP inspections. Covers the 10 most-cited GMP deficiencies, document availability and version control checks, personnel readiness, facility walkthrough preparation, and back-room documentation organization. Includes common inspector questions and response guidance for manufacturing personnel.
Why It Works
150+ GMP assessment points
The gap assessment covers every 21 CFR 820 QMSR and ISO 13485 requirement with risk ratings — so you know which gaps to fix first before your next inspection.
DHR-compliant batch records
The batch record template is structured to satisfy FDA 21 CFR 820.184 DHR requirements out of the box — one of the top citations on FDA 483s.
Inspection day ready
The readiness assessment covers what FDA investigators actually look for during a facility walkthrough — built from real inspection experience, not from reading the regulation.
From the Field
"GMP compliance is not about having the right SOPs — it is about running your facility the way FDA expects it to look on the day of an unannounced inspection. These templates close the gaps that generate 483s."
"The gap assessment alone identified 14 items we had never formally documented. Getting ahead of those before an FDA inspection was worth far more than the cost of the toolkit."
FAQ
Does this cover the new FDA QMSR (21 CFR Part 820)?
Yes. The gap assessment is aligned with both the 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 contract manufacturers (CMOs) operating under a Quality Agreement with the finished device manufacturer.
What format are the documents?
All documents are editable Word and Excel templates ready for direct use as controlled QMS documents.
Ready to get started?
6 templates. Instant access. Built for FDA GMP compliance.
For informational purposes only. Not legal or regulatory advice. Legal