(Download: Medistri Joins the Swiss GLP Compliance Monitoring Programme in PDF by Medistri)
At Medistri, we are proud to announce that our laboratory has officially been enrolled in the Swiss Good Laboratory Practice (GLP) Compliance Monitoring Programme. The formal decision was issued by the Notification Authority for Chemicals (NAChem) at the Federal Office of Public Health, following a successful inspection process conducted by Swissmedic. Our facility will appear on the official GLP register effective 13 May 2026.
What Is Good Laboratory Practice?
Good Laboratory Practice (GLP) is an internationally recognised quality system established by the Organisation for Economic Co-operation and Development (OECD). GLP principles ensure the quality, integrity, and reliability of non-clinical safety studies. Facilities operating under GLP are subject to regular inspections by national monitoring authorities — in Switzerland, this programme is overseen by the Federal Office of Public Health and inspected by Swissmedic and the Federal Office for the Environment (FOEN). Enrolled facilities are re-inspected on a routine basis every two to three years, in accordance with the Ordinance on Good Laboratory Practice (OGLP).
GLP compliance provides assurance that study data is generated under controlled, documented, and reproducible conditions. For manufacturers of medical devices and pharmaceutical products, partnering with a GLP-compliant laboratory strengthens the credibility and regulatory acceptance of safety data across international markets.
Scope of Medistri’s GLP Compliance
Our GLP compliance covers a comprehensive range of analytical, biological, and microbiological testing activities. The full scope includes:
Chemical Characterization
- Total Organic Carbon (TOC)
- Hydrocarbon Testing (HCT)
- EO/ECH/EG Testing (Ethylene Oxide, Ethylene Chlorohydrin, Ethylene Glycol)
- VOC & SVOC (Volatile and Semi-Volatile Organic Compounds)
Biological Testing
- Cytotoxicity (ISO 10993-5)
Microbiological Method Validation
- Bioburden Sterility
- Endotoxin (Endosafe Cartridge)
- Germ Identification (VITEK)
Cleanliness & Residue Testing
- Sub-visible Particles (Light Obscuration)
- Protein & Hemoglobin
This scope complements and strengthens our existing ISO 17025 accreditation, adding a further layer of internationally recognised quality assurance to key areas of our testing portfolio.
A Unique Position in the Swiss GLP Landscape
The Swiss GLP Compliance Monitoring Programme currently includes approximately 20 test facilities, the majority of which focus on pharmaceutical toxicology, ecotoxicology, bioanalytical chemistry, or pathology review. Only a small number of facilities on the register are directly relevant to the safety testing of medical devices. With our enrollment, Medistri becomes the only Swiss GLP-compliant facility to combine chemical characterization, cytotoxicity testing, microbiological method validation, and cleanliness testing within a single GLP scope. Other Swiss GLP facilities with relevance to the medical device sector tend to specialize in narrower areas — for example, analytical and physical-chemical testing, or in vivo biocompatibility and efficacy studies. No other facility on the register covers the breadth of cleaning validation and biological safety testing that Medistri now offers under GLP.
For manufacturers, this means the ability to consolidate multiple GLP-compliant safety tests with a single laboratory partner — reducing coordination complexity, shortening timelines, and ensuring consistency across the testing programme.
What This Means for Our Clients
For medical device and pharmaceutical manufacturers, GLP compliance at Medistri means that safety-critical data generated in our laboratory meets the highest internationally accepted standards of quality and traceability. Studies conducted under GLP are recognised by regulatory authorities worldwide, including the FDA, European notified bodies, Swissmedic, and other OECD member-country authorities. Practically, this provides our clients with:
- Enhanced regulatory acceptance: GLP study data is recognised across OECD member countries, supporting international submissions and reducing the risk of regulatory queries.
- Greater confidence in safety data: GLP principles ensure that every step of a study — from planning to reporting — is documented, traceable, and reproducible.
- A single partner for the full testing chain: Medistri’s unique GLP scope means manufacturers can consolidate chemical characterization, biological safety, microbiological validation, and cleanliness testing with one laboratory — under both ISO 17025 accreditation and GLP compliance.
- Faster, more streamlined projects: Working with a single GLP-compliant partner eliminates the need to coordinate between multiple laboratories, reducing administrative burden and accelerating time-to-market.
To learn more about Medistri’s Laboratory, please visit our website here. To ensure your products meet the highest quality and safety standards, contact our dedicated team at contact@medistri.com.
— The Medistri Team
#Medistri
Medistri is Europe's leading independent contract sterilization company, founded in 2006 and headquartered in the heart of Switzerland. We are a global player providing essential infrastructure that powers healthcare innovation worldwide. We serve customers of all sizes, from startups, university projects, and research institutes to Fortune 500 corporations, across Medical Devices, Pharmaceutical Packaging, and Biotech. Medistri supports products at every stage of the lifecycle: pre-clinical development, go-to-market, and full industrialization.
Our fully integrated, end-to-end in-house solution allows our customers to focus on what matters most: engineering, innovation, and development, while we manage the critical back-end processes. Our synchronized departments work together to provide a complete stack of services:
- Contract Sterilization & Validation Services
- Contract Laboratory Services
- Contract Manufacturing Services
- Logistics Services
- Consulting Services
We help you accelerate time-to-market, reduce barriers to scale, and deliver safer, more sustainable healthcare solutions to patients around the world.
Frequently Asked Questions
1. What is Good Laboratory Practice (GLP) and why is it important?
Good Laboratory Practice is an internationally recognized quality system that governs the planning, performance, monitoring, and reporting of non-clinical safety studies. It ensures that study data is reliable, traceable, and generated under controlled conditions, supporting regulatory acceptance worldwide.
2. Why is Medistri’s enrollment in the Swiss GLP Compliance Monitoring Programme significant?
Enrollment confirms that Medistri’s laboratory operates in accordance with GLP principles and has successfully passed regulatory inspection. This status places the facility on the official Swiss GLP register and demonstrates compliance with internationally accepted standards.
3. How does GLP compliance differ from ISO 17025 accreditation?
ISO 17025 focuses on laboratory competence and the validity of analytical methods, while GLP governs the overall conduct and documentation of safety studies. Together, they provide complementary assurance covering both technical performance and regulatory study integrity.
4. When is GLP-compliant testing required for medical devices and pharmaceutical products?
GLP compliance is required when generating non-clinical safety data intended for regulatory submissions. This includes studies supporting biological evaluation, toxicology, and safety assessments reviewed by authorities such as FDA, notified bodies, and OECD member countries.
5. How does Medistri support manufacturers through its GLP-compliant laboratory services?
Medistri provides a broad range of GLP-compliant testing, including chemical characterization, cytotoxicity, microbiological validation, and cleanliness analysis. By combining these capabilities within a single laboratory, Medistri helps ensure consistent data generation, regulatory acceptance, and streamlined project execution.