Packaging and Labeling Management templates for FDA QMSR compliance.
Preview before you buy: Download a watermarked sample PDF showing the cover, table of contents, and sample sections.
Covers 21 CFR §820.35 Labeling and Packaging Operations (QMSR retained), including UDI/GUDID requirements.
What’s Included
Policy & SOP (16-file bundle)
- 📄 MD-QMS-K90 Packaging & Labeling Management Policy
- 📄 SOP for Labeling and Packaging Operations
Forms (F9001-01 to 14)
- 📄 F9001-01 Receiving Inspection Record (Purchased Labeling)
- 📄 F9001-02 Label Issuance Instruction
- 📄 F9001-03 Label Reissuance/Destruction Record
- 📄 F9001-04 In-Process Inspection Record (Issued Labels)
- 📄 F9001-05 Labeling Dispensing Record
- 📄 F9001-06 Labeling Operations Checklist (Manufacturing)
- 📄 F9001-07 Line Clearance Record
- 📄 F9001-08 Packaging Work Record
- 📄 F9001-09 Product Inspection Record (Labeling)
- 📄 F9001-10 Distribution Release Approval Record
- 📄 F9001-11 UDI/DI Acquisition (GUDID Registration)
- 📄 F9001-12 UDI Verification Record
- 📄 F9001-13 Label Change Impact Analysis Report
- 📄 F9001-14 Labeling Training Competency Record
Table of Contents (Policy Document)
- Purpose / Scope / Normative References / Definitions
- Packaging Management
- Labeling Requirements (incl. UDI/GUDID per 21 CFR Part 830)
- Line Clearance & Reconciliation
- References / Supplementary Provisions
Aligned to 21 CFR Part 820 (QMSR) and ISO 13485:2016. Drafted by specialists with 30+ years of FDA inspection experience.
📄 Preview the Document Before You Buy
Confident purchase decisions start with knowing what’s inside. Download a watermarked sample showing the cover page, table of contents, and the first sections — so you can verify scope, structure, and language fit your QMS before adding to cart.
Table of Contents — FDA QMSR Packaging and Labeling Management Policy, SOP & Forms
- Purpose
- Scope
- Definitions
- Roles and Responsibilities
- Procedure
- References
- Supplementary Provisions
4-page sample preview
Cover · TOC · Sample sections
Watermarked PDF
The sample is provided for evaluation only. Full editable Microsoft Word files (without watermark) are delivered immediately upon purchase. © eCompliance Ltd. — All rights reserved.
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