REGULATORY ASSURANCE & AUDIT COMPLIANCE

Quality & Compliance at the Core of Our Operations

Stringent cGMP protocols, ISO 9001:2015 certification, and FSC Chain of Custody standards ensuring zero-defect packaging for regulated healthcare markets.

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PHARMACEUTICAL QUALITY COMMITMENT

Uncompromising Quality Standards for Patient Safety

In pharmaceutical secondary packaging, quality is not merely an inspection checkpoint—it is the foundational pillar of patient safety and brand protection. Prince Art Packages operates under a total quality management philosophy where every printed carton, prescribing leaflet, and security label is engineered to prevent line stoppages, eliminate artwork mix-ups, and withstand rigorous regulatory audits.

Zero Error Tolerance

Rigorous SOPs and continuous line monitoring ensure zero deviation from approved technical specifications.

100% Batch Traceability

Full end-to-end documentation from incoming raw paperboard reels to finished carton dispatch with assigned batch codes.

Independent QA Oversight

Our Quality Assurance department operates with full autonomous stop-production authority across both manufacturing plants.

Continuous Reinvestment

Ongoing capital investments in calibrated optical testing instruments, inline sensor inspection, and automated tooling.

GLOBAL ACCREDITATIONS

Internationally Verified Certifications & Standards

Our dual manufacturing facilities in Korangi Creek Industrial Park, Karachi, operate in full compliance with internationally recognized quality and environmental stewardship frameworks.

cGMP Compliant Line Clearance & Cleanliness
ISO 9001:2015 Cert # KQ.2025.5393 (ASCERT)
FSC Chain of Custody License FSC-C222205
EN 16679 & Marburg Tamper Evidence & Braille
MANUFACTURING DISCIPLINE

cGMP Compliance & Zero-Mixup Packaging Controls

Current Good Manufacturing Practices (cGMP) govern every step of our printing, folding, gluing, and converting workflows. Designed specifically for pharmaceutical clients, our facility protocols eliminate cross-contamination and ensure audit-ready consistency.

Formal Line Clearance Protocols

Documented multi-point physical and digital line clearance before and after every production run to ensure no leftover material from previous batches.

100% Optical Barcode & Pharma-Code Verification

High-speed sensor cameras on folder-gluers and leaflet folding lines verify 100% of 2D DataMatrix and miniature barcodes with automated pneumatic rejection.

Controlled Environmental Conditions

Temperature and humidity-regulated converting halls protect paperboard dimensional stability and prevent moisture warping.

Complete Batch Production Records (BPR)

Every batch is accompanied by comprehensive Batch Manufacturing Records (BMR) detailing operators, machine parameters, ink lot numbers, and QC signatures.

AUDITED & ACCREDITED

Certified Quality Management & Sustainability

Our accredited ISO 9001:2015 Quality Management System and FSC Chain of Custody certifications provide independent, verified assurance of process rigor, raw material traceability, and sustainable manufacturing.

ISO 9001:2015 Quality Management System

Quality Management System Standard

Certificate No: KQ.2025.5393

Certification Body: ASCERT Certification and Training Services LLC

Accreditation ID: MSCB-223

Scope: Scope: Purchasing of paper materials, production and sales of pharmaceutical secondary packaging products.

Our certified Quality Management System enforces structured risk assessment, calibrated measurement tracking, supplier audits, and systematic root-cause corrective actions (CAPA).

FSC Chain of Custody Certification

Responsible Forest Resource Chain of Custody

Certificate No: RR-COC-003348

FSC License Code: FSC-C222205

Standard & Validity: FSC-STD-40-004 (Validity: 19 Nov 2025 – 18 Nov 2030)

Scope: Scope: FSC 100%, FSC Mix, and FSC Recycled paper product manufacturing and supply.

Guarantees that all virgin boxboards and lightweight leaflet papers are sourced from responsibly managed forests adhering to strict environmental, social, and economic sustainability standards.

RAW MATERIAL QUALITY ASSURANCE

Incoming Material Inspection & Laboratory Testing (OurLAB)

Zero-defect packaging starts with flawless raw materials. Every incoming shipment of paperboard, inks, varnishes, foils, and adhesives undergoes rigorous quarantine and laboratory verification prior to release into production.

GSM & Caliper Micrometer Verification

Digital micrometer gauges and precision analytical balances verify paperboard thickness (microns) and substance (GSM) within ┬▒2% tolerances.

Moisture Content & Cobb Sizing Analysis

Electronic moisture analyzers and Cobb sizing testers measure board water absorption capacity to prevent carton curling and delamination.

Spectrophotometric Ink & Delta-E Tolerance

Low-migration vegetable oil-based inks are calibrated with digital spectrophotometers to maintain Delta-E color variance under 1.5 across production.

Adhesive Tack, Viscosity & Fiber-Tear Testing

Medical-grade adhesives and hot-melts are tested for bonding strength and guaranteed fiber tear under ambient, refrigerated, and deep-freeze temperatures.

Dedicated In-House Facility

OurLAB — Advanced Quality Control Laboratory

Equipped with state-of-the-art X-Rite spectrophotometers, Sutherland ink rub testers, digital Cobb testers, and calibrated Braille depth micrometers, OurLAB executes rigorous pre-press, in-process, and post-converting quality clearance for every pharmaceutical batch.

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Frequently Asked Questions

Quality, Compliance & Audit FAQs

Explore detailed answers regarding our pharmaceutical packaging audit procedures, Certificate of Analysis (CoA) dispatch, line clearance verification, and laboratory testing protocols.

Can our Quality Assurance and Regulatory team conduct an on-site facility audit?

Yes, absolutely. We regularly host scheduled facility audits for multinational pharmaceutical manufacturers, regulatory authorities, and independent inspection bodies. We provide full access to our SOPs, equipment validation documentation, calibration logs, and cGMP production floors in Korangi Creek, Karachi.

Do you provide a Certificate of Analysis (CoA) with every delivered batch?

Yes. Every dispatched shipment is accompanied by a formal Certificate of Analysis (CoA) and Certificate of Conformance (CoC) signed by our QA Manager, detailing substrate GSM, caliper, moisture levels, ink batch numbers, barcode scan grades, and line clearance verification.

How is line clearance managed between different customer packaging runs?

We enforce strict 3-tier cGMP line clearance SOPs. Before any new job begins, the previous job materials, plates, cutting dies, waste, and documentation are completely cleared from the packaging cell. Line clearance is physically inspected and dual-signed by the Line Incharge and the QA Inspector before machine startup.

What spectrophotometric color tolerances (Delta-E) do you guarantee?

Our offset presses operate with closed-loop inline spectrophotometry and densitometry calibrated to X-Rite Pantone digital color standards. We maintain Delta-E (ΔE) color variances under 1.5 to guarantee exact brand shade consistency across multiple batches over years of production.

How is Braille embossing verified on pharmaceutical cartons?

Braille embossing is applied in-line using precision CNC tooling compliant with the Marburg Medium standard (European Directive 2004/27/EC). Our QA laboratory verifies dot height (0.20 mm standard) and dot spacing across sampling sheets using calibrated optical depth micrometers.

What is your procedure for Corrective and Preventive Actions (CAPA)?

Under our ISO 9001:2015 QMS framework, any identified non-conformance initiates a structured CAPA investigation utilizing 5-Why root-cause analysis and Ishikawa fishbone diagrams. Corrective actions are implemented, documented, and audited for long-term effectiveness within 14 business days.

AUDIT-READY PHARMACEUTICAL PACKAGING

Schedule a Facility Audit or Request Quality Manual

Speak directly with our Quality Assurance Directorate to arrange an on-site audit, request technical compliance dossiers, or review our laboratory testing capabilities.

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