Does this tool upload my pharmaceutical documents to a server?

No. All processing runs entirely in your browser using WebAssembly. Your files never leave your device — fully compliant with GDPR Article 25 and Irish Data Protection Act 2018.

Is this tool compliant with FDA 21 CFR Part 11?

Because all processing is client-side, no third party stores a copy of your electronic records. This removes a significant 21 CFR Part 11 audit risk. Consult your Compliance team to assess fit in your programme.

GMP Document Stamp Tool for Pharma — FDA · EU GMP · HPRA · Ireland

10 GMP-Standard Stamp Presets

Colour-coded per GxP convention — green (valid/active) · red (restricted/superseded) · blue (informational)

APPROVED

CONTROLLED COPY

FOR REVIEW

GMP COMPLIANT

SAMPLE

DRAFT

SUPERSEDED

VOID

CONFIDENTIAL

NOT FOR DISTRIBUTION

Why GMP Document Stamping Is a Regulatory Requirement

Missing or informal status markings are one of the most common HPRA, EMA, and FDA inspection findings.

Common GMP inspection finding: "Documents in use on the manufacturing floor were not clearly marked with their approval status, revision number, or controlled copy designation." — HPRA / EMA inspection report pattern

Regulatory Compliance Framework

This tool supports document control requirements across all major regulatory frameworks.

🇺🇸

FDA 21 CFR Part 11

Electronic Records & Signatures

Client-side only — no third-party record storage
Zero audit risk from cloud record exposure
Permanent embedded stamps support record integrity

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FDA 21 CFR Part 820

Quality System Regulation — Medical Devices

APPROVED and SUPERSEDED stamps enforce version control
Supports ISO 13485 and EU MDR document management
Suitable for DHF, risk files, device master records

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EU GMP Annex 1 (2022)

Sterile Manufacturing Document Control

Controlled Copy and Approved stamps for shop-floor issue
Superseded marking required for withdrawn documents
Supports sterile batch record document control

🌐

ICH Q10

Pharmaceutical Quality System

PQS requires robust document lifecycle management
Version status visibility is a foundational ICH Q10 expectation
Supports all lifecycle stages — development to post-market

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HPRA — Ireland

Health Products Regulatory Authority

HPRA inspections routinely cite inadequate document control
Consistent stamps demonstrate an auditable QMS
Operated from Ireland — Irish Data Protection Act 2018

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GDPR Article 25

Privacy by Design

Zero file upload — documents never leave your device
No cloud storage, no third-party processors
Full compliance with Irish & EU data protection law

How to Use the GMP Stamp Tool — Step by Step

7 steps from upload to download. No account, no installation, no subscription.

Open the Tool — No Login Required

Visit pdf.priyalifescience.com/en/tools/gmp-stamp. No account, plugin, installation, or subscription is needed. Runs in any modern browser.

Upload Your Pharmaceutical PDF

Drag and drop your SOP, batch record, validation protocol, dossier component, or any GxP document. The PDF loads into your local browser memory — never transmitted to any server.

Select a GMP Stamp Preset

Choose from 10 standardised GxP presets. Green for valid/active status, red for restricted or withdrawn, blue for informational. Colour-coding follows GMP convention across EU and US-regulated environments.

Adjust Opacity

Use the slider (30%–100%) to set stamp transparency. Lower opacity keeps the stamp visible without obscuring critical document text beneath it — essential for GMP readability compliance on batch records and protocols.

Place and Drag to Position

Click "Place Stamp on Page" then drag the stamp to any location — top-right corner, document header, or diagonal — to match your site QMS standard.

Stamp Multiple Pages

Use the Previous / Next navigation to move through your document. Stamp each page as required. All stamps across all pages are tracked in the sidebar summary.

Save and Download

Click "Save Stamped PDF". Stamps are permanently embedded using pdf-lib running locally. Your browser downloads the finished document. No server request is made at any stage.

Who Uses This Tool

Pharma, MedTech, biotech and life science professionals in Ireland and across the EU.

QA Manager

Issues APPROVED / SUPERSEDED stamps to controlled documents before distribution to the manufacturing floor.

Regulatory Affairs Officer

Stamps dossier components as DRAFT or CONTROLLED COPY during HPRA, EMA, or FDA submission preparation.

Validation Engineer

Marks IQ/OQ/PQ protocols as FOR REVIEW before routing for subject matter expert and QA sign-off.

Manufacturing / Operations

Receives GMP COMPLIANT or CONTROLLED COPY stamped batch records and manufacturing instructions for the production floor.

Clinical Trial Coordinator

Applies CONFIDENTIAL or DRAFT status to Investigator Brochures, protocols, and Informed Consent Forms under ICH E6 GCP.

MedTech / Device Teams

Maintains 21 CFR Part 820 and MDR-compliant document lifecycles for Design History Files, risk files, and device master records.

Document Control Specialist

Maintains a consistent, auditable visual status system across all QMS-controlled document categories.

Training Coordinator

Marks training materials as SAMPLE or FOR REVIEW to clearly distinguish them from issued controlled versions.

Document Types & Recommended GMP Stamps

Quick reference for common GxP document lifecycle status assignments.

Document Type	Recommended Stamp(s)
Standard Operating Procedures (SOPs)	APPROVED / SUPERSEDED
Batch Manufacturing Records (BMRs)	CONTROLLED COPY / GMP COMPLIANT
Validation Protocols (IQ / OQ / PQ)	FOR REVIEW / APPROVED
Regulatory Submission Dossiers (HPRA / EMA / FDA)	DRAFT / CONTROLLED COPY
Investigator Brochures (IB) / Clinical Protocols	CONFIDENTIAL / DRAFT
Informed Consent Forms (ICF)	FOR REVIEW / APPROVED
CAPA & Deviation Reports	DRAFT / APPROVED
Change Control Documentation	FOR REVIEW / APPROVED
Quality Agreements	CONTROLLED COPY
Medical Device Technical Files (MDR / 21 CFR 820)	APPROVED / SUPERSEDED
Design History Files (DHF)	CONTROLLED COPY / APPROVED
GMP Training Materials	SAMPLE / FOR REVIEW

Frequently Asked Questions

No. Zero bytes of your document are transmitted at any stage. All PDF processing runs entirely in your browser using WebAssembly (WASM) and pdf-lib. You can verify this yourself: open DevTools → Network tab → run the tool — you will see zero requests for your file. Suitable for SOPs, batch records, clinical trial materials, and regulatory dossiers under any data classification.

FDA 21 CFR Part 11 requires electronic records to be trustworthy and not subject to unauthorised alteration. Because this tool is entirely client-side — no third party receives, stores, or processes a copy of your records — it removes a significant Part 11 audit risk. Consult your Compliance team to assess fit within your 21 CFR Part 11 programme.

Yes. 21 CFR Part 820 requires document control to ensure only approved, current-revision documents are in use. APPROVED, SUPERSEDED, and CONTROLLED COPY stamps directly support the document identification and approval requirements of Part 820. Used by MedTech teams in Ireland for exactly this purpose.

10 standardised presets: APPROVED (green), CONTROLLED COPY (green), FOR REVIEW (green), GMP COMPLIANT (green), SAMPLE (blue), DRAFT (red), SUPERSEDED (red), VOID (red), CONFIDENTIAL (red), NOT FOR DISTRIBUTION (red). Colour-coded per GxP convention.

Yes. Use Previous/Next page navigation to move through your document and place stamps on each page as required. All stamps across all pages are compiled and saved in a single downloaded PDF.

Yes, completely free. Priya PDF Editor is open source under the AGPL-3.0 licence, with source code on GitHub. No accounts, subscriptions, upload fees, or data-sharing of any kind.

Digital PDF stamps are permanent, consistent, scalable, instantly verifiable, and aligned with ICH Q10 electronic document management expectations. Physical stamping adds print-scan cycles that degrade document quality and introduce version-control risk.

Apply Your First GMP Stamp — Free

No account needed. No installation. FDA · EU GMP · HPRA · GDPR compliant. Open source.
Operated by Priya Life Science, Ireland.

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GMP Document Stamp Toolfor Pharma & Life Science