We help people live a healthy life in a healthy world
Polpharma operates a single Quality Management System across all manufacturing sites, ensuring consistent standards and continuous improvement throughout the organization. All medicinal product and API manufacturing facilities are certified to EU GMP standards, and our API operations are additionally certified by the U.S. FDA, demonstrating our commitment to global quality and patient safety.
product and API batches
released to the market each year
+15 500
Analytical laboratory area
+8000 m2
Number of chromatographs (HPLC/GC/UPLC) in QC
laboratories across the Polpharma Group:
+130
People working across
the Group's quality functions
700
Security of supply
The same quality standard applies across the whole Group, at every site.
The Quality Policy sets that standard and the principles behind it. It's approved by the President of the Management Board and applies to every site and every employee.
The quality, effectiveness and safety of our products are the highest priority for the whole Group. We build quality in at every stage, and every one of us - wherever we work - is responsible for what reaches the patient.
quality management system
One quality system covers every site, from active-substance synthesis to finished dose.
The same system applies whether we make the product or manufacture it for a partner. The four areas below are the parts that make it up.
Regulatory compliance
Independent verification that our processes meet GMP and internal standards.
Regulatory checks that confirm our quality system works and is ready for global markets.
GMP data kept complete, accurate and reliable across its lifecycle.
Quality operations
Oversees compliance across manufacturing and quality systems, making sure products are made and controlled to approved standards.
Verifies that materials and products meet their specifications through rigorous testing and scientific evaluation at every stage.
Continuous improvement
Investigates deviations and findings, and fixes the root cause to prevent recurrence.
Identifies, assesses and monitors quality risks across the product lifecycle.
Evaluates, approves and implements changes in a controlled way to protect GMP compliance and product quality.
People and partners
Keeps employees' knowledge, skills and GMP awareness current, so everyone has the competence their role requires.
Works with qualified suppliers, with ongoing qualification and monitoring to keep the whole supply chain sound.
Quality Certifications and Regulatory Excellence
All Polpharma Group manufacturing sites maintain certifications and regulatory approvals appropriate to their activities and product portfolios. Our facilities regularly undergo inspections by national and international authorities, confirming compliance with applicable regulatory requirements and GMP standards. This enables us to manufacture and supply pharmaceuticals, APIs and medical devices to markets worldwide.
AUDITS & INSPECTIONS
Our quality system undergoes continuous, independent verification.
Audits and inspections are a cornerstone of our quality culture and continuous improvement journey. Each year, Polpharma successfully undergoes more than 50 customer audits and around five regulatory inspections, providing valuable opportunities to strengthen compliance, enhance processes, and reinforce confidence in the quality of our products and operations.
quality culture
A quality system is only as strong as the culture behind it.
Great quality doesn't come from procedures alone - it comes from people who care. We nurture that culture through communities, forums and shared initiatives across the Group. Here's how we live it.
"Behind every tablet, capsule, or vial of medicine, there is a patient. That is why quality is the foundation for building trust, a way of thinking, and a real standard of action."
marcin turzyński Operations Director
partner with the gorup
Due diligence moves faster when the documents are ready
The Quality team answers audit requests, documentation enquiries and qualification questionnaires directly.