Quality
Our mindset.
Designed and built to the highest standards
Quality is at the core of everything we do. From design to implementation, we work with care and precision to deliver high-quality solutions for the pharmaceutical industry. Gpi Pharma manufactures stainless steel tanks and pressure vessels that uphold the highest standards of hygiene, safety, and reliability. Certified to international standards, our products fully comply with all relevant guidelines and regulations, providing verifiable assurance that both our processes and products meet the strictest requirements of clients and regulatory authorities.
Certified Operations
To meet the stringent requirements of the pharmaceutical industry, it is essential to operate in accordance with established quality and safety standards. Gpi Pharma holds a range of certifications that demonstrate our processes, materials, and procedures consistently comply with these standards. Below, you will find an overview of the key certifications that underpin our operations.
Certifications
ISO 9001
Our ISO 9001 certification confirms that we operate according to a structured quality management system, with a strong focus on customer satisfaction, process control, and continuous improvement. This provides our clients with assurance at every stage of design, production, and delivery.
ISO 14001
ISO 14001 is an international standard for environmental management. This certification confirms that Gpi Pharma has an effective management system to meet applicable environmental regulations and performance requirements. The system incorporates processes for monitoring energy consumption, waste streams, and compliance with relevant laws and regulations.
ISO 45001
ISO 45001 confirms that we actively manage risks and are committed to the well-being of our employees, partners, and visitors. For our clients, this means collaborating with an organization where safety is structurally embedded in all processes.
EN 1090-1 EXC3
For pharmaceutical applications involving load-bearing structures, we meet EN 1090-1 standards up to Execution Class 3. This enables us to deliver complex steel constructions with welded assemblies that consistently meet the highest requirements for safety, stability, and traceability.
ISO 3834-2
This standard guarantees that our welding meets the highest international requirements. Our qualified welders follow established procedures, with full documentation and quality assurance available for each weld if required
PED Module H
Our PED certification under Module H confirms that we are authorized to independently design, manufacture, and inspect pressure vessels in full compliance with the European Directive 2014/68/EU. This applies to applications with a working pressure above 0.5 bar, where CE marking is required. It contributes to faster lead times while ensuring full compliance.
PED Module H1
By combining internal production control with independent assessment, this certification provides added assurance for applications with higher risks or strict validation requirements.
Additional certifications
On request, we can supply components that meet widely recognized standards such as USP Class VI, FDA compliance, ADI-free, and the EC 1935/2004 directive. This enables us to deliver solutions suitable for applications in the food and pharmaceutical industries. Examples include hoses, seals, O-rings, coatings, and plastics that are biocompatible, non-toxic, and free of animal-derived materials. If required, we can also provide a BSE/TSE declaration.
Standards and guidelines
GMP
Good Manufacturing Practice (GMP) forms the foundation of pharmaceutical production processes. At Gpi Pharma, we design and build tanks that comply with GMP requirements, from material selection to final delivery. This ensures full traceability of materials used, validated processes, and extensive documentation of the design, performed tests, required certifications, and relevant manuals. Good Documentation Practice (GDP) is also an essential part of this approach. In this way, we ensure compliance and tanks that are fully audit-ready.
EN 13445
EN 13445 is a European standard for the design and fabrication of unfired pressure vessels, serving as an alternative to ASME. The standard sets strict requirements for material selection, stress analysis, manufacturing, and inspection. By working in accordance with EN 13445, our pressure vessels meet strict safety requirements within the European market. Upon request, we can also comply with ASME VIII.
ASME BPE
ASME BPE is an international standard for bioprocess equipment in the pharmaceutical and biotechnology industries. It sets requirements for surface finishing, welding, and cleanability, ensuring optimal performance in sterile and hygienically critical environments. When required, we provide components and systems designed in full compliance with ASME BPE.
PED (Pressure Equipment Directive)
The European Pressure Equipment Regulation (PED – 2014/68/EU) applies to pressure equipment with a working pressure above 0.5 bar. Tanks covered by this regulation must carry CE marking, depending on their pressure-volume rating. Gpi Pharma is certified to independently design, manufacture, and inspect pressure vessels in accordance with PED, including Modules H and H1. This provides maximum assurance of safety and full compliance with European requirements.
Other relevant standards
When selecting pipes and components, various international standards may be applied, such as EN 10357 (the European standard for hygienic piping) and ASTM A270 (the American standard for sanitary stainless steel piping). Depending on the application and specifications, we can provide solutions that meet these standards.
Good Manufacturing Practice (GMP) forms the foundation of pharmaceutical production processes. At Gpi Pharma, we design and build tanks that comply with GMP requirements, from material selection to final delivery. This includes full traceability of all materials used, validated cleaning processes (CIP/SIP), and comprehensive documentation covering design, performed tests, required certifications, and relevant commissioning manuals (such as DQ, IQ, OQ, and PQ). Good Documentation Practice (GDP) is also an essential part of this approach. In this way, we ensure compliance and tanks that are fully audit-ready
Learn more?
Do you have questions about our standards, certifications, or how we ensure quality in pharmaceutical projects? Please feel free to contact us. Our team is ready to advise you and help identify the best solution for your application.