FDA QMSR Packaging and Labeling Management Policy, SOP & Forms

¥319,500

FDA QMSR Packaging and Labeling Management Policy, SOP & Forms

FDA QMSR Packaging and Labeling Management Policy, SOP & Forms

¥319,500

Packaging and Labeling Management templates for FDA QMSR compliance.

Quantity

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✅ Common Features Across All QMS Templates

🇺🇸 FDA QMSR (21 CFR Part 820)
·
🌐 ISO 13485:2016 §7.5.11
·
📝 MS Word (.docx)
·
🔄 Immediate Use
·
🎬 Video Guidance on YouTube

Overview

A complete packaging and labeling management template set for FDA QMSR compliance. Covers package design validation, labeling review and approval, label control procedures, and sterile barrier system requirements for medical device packaging.

Regulatory Reference: ISO 13485:2016 §7.5.11 — Preservation of Product / Labeling

Why You Need This

ISO 13485:2016 §7.5.11 and FDA QMSR have strict packaging and labeling requirements. Labeling errors are a leading cause of medical device recalls. This template prevents costly labeling mistakes.

What’s Included

Document Type Description
📄 Policy Document 1 file — Organizational policy & management framework
📋 SOP / Procedure MD-QMS-S9001 Packaging Labeling Management SOP
📝 Form / Template F9001-01 Receiving Inspection Record Purchased Labeling
📝 Form / Template F9001-02 Label Issuance Instruction
📝 Form / Template F9001-03 Label Reissuance Destruction Record
📝 Form / Template F9001-04 InProcess Inspection Record Issued Labels
📝 Form / Template F9001-05 Labeling Dispensing Record
📝 Form / Template F9001-06 Labeling Operations Checklist Manufacturing
📝 Form / Template F9001-07 Line Clearance Record
📝 Form / Template F9001-08 Packaging Work Record
📝 Form / Template F9001-09 Product Inspection Record Labeling
📝 Form / Template F9001-10 Distribution Release Approval Record
📝 Form / Template F9001-11 UDI DI Acquisition GUDID Registration
📝 Form / Template F9001-12 UDI Verification Record
📝 Form / Template F9001-13 Label Change Impact Analysis Report
📝 Form / Template F9001-14 Labeling Training Competency Record

📋 Policy — Table of Contents

Purpose
Scope
Normative References
Definitions
Packaging Management
General Requirements
Risk Analysis for Packaging
Packaging Material Development
Packaging Process Validation
Labeling Requirements
General Labeling Requirements
Labeling Integrity
Unique Device Identification (UDI)
Labeling Inspection and Storage
Labeling Operations and Mixup Prevention
Control Numbers (Traceability)
References
Supplementary Provisions

📋 MD-QMS-S9001 Packaging Labeling Management SOP — Table of Contents

Purpose
Scope
Definitions
Roles and Responsibilities
Receiving Inspection of Purchased Labeling
In-Process Label Issuance
Label Issuance
Label Re-issuance
In-Process Inspection of Issued Labels
Labeling Storage
Labeling Issuance (Dispensing)
Labeling Operations
Manufacturing Process Labeling Operations
Packaging Process Labeling Operations
Product Inspection of Labeling
UDI Management
GUDID Registration and UDI-DI Management
UDI-PI (Production Identifier) Management
Label Specification Change Management
Training
Record Retention
References
Supplementary Provisions

Key Features

  • Fully aligned with ISO 13485:2016 §7.5.11 (Preservation of Product / Labeling)
  • Written for immediate use — minimal customization required
  • Structured for FDA QMSR (21 CFR Part 820) compliance
  • Microsoft Word format (.docx) — easy to edit and adapt
  • Professional quality suitable for FDA inspection review
  • Includes all required procedural elements and record templates
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