Pharmalys is proud to announce the successful completion of its most recent Good Clinical Laboratory Practice (GCLP) surveillance audit, conducted on 9-10 March 2026 at Proteome Sciences R&D GmbH & Co. KG in Frankfurt am Main, Germany. We are grateful for the open collaboration, the professionalism of the team, and the long-standing partnership grounded in scientific rigour, transparency, and a shared commitment to quality.
Proteome Sciences has been GCLP‑accredited since October 2017, consistently demonstrating strong performance in regulated laboratory operations. Their continued participation in the Pharmalys GCLP Accreditation Scheme reflects their dedication to maintaining robust quality standards, and this year’s surveillance audit confirmed their ongoing adherence to the highest expectations for clinical laboratory practice.
Audit scope: Precision-driven targeted proteomics
The surveillance audit focused on Proteome Sciences’ portfolio of targeted quantitative mass spectrometry assays, specifically using:
- Selected Reaction Monitoring (SRM)
- Parallel Reaction Monitoring (PRM)
These targeted proteomics methods enable the sensitive, selective, and reproducible measurement of specific proteins or peptides – critical technologies that support robust biomarker verification, clinical research, and regulated bioanalytical studies.
The assessment confirmed that the laboratory continues to operate in full alignment with GCLP principles across method execution, documentation, quality systems, and data integrity.
Acknowleding expertise and collaboration
The success of the audit is very much thanks to the knowledge, preparation, and constructive engagement of the Proteome Sciences team. Their willingness to discuss processes openly and their commitment to continuous improvement made the audit both efficient and positive.
Pictured from left to right (in the photo above):
- Karsten Kuhn, Head of Chemistry and Quality Management
- Stephanie Ballweg, Analytical Project Manager
- Jeanette Young, Laboratory Solutions and GCLP Team Lead at Pharmalys
- Josef Schwarz, Operations and Quality Projects Manager
- David Van Meter, Chief Operating Officer
We are grateful and appreciative for the time and collaboration provided by everyone involved, and that Proteome Sciences continues to place their trust in the process and remains committed to upholding high-quality standards year after year.
Learn more about GCLP Accreditation at Pharmalys
If your organisation is exploring GCLP accreditation or would like to strengthen its existing quality framework, you can learn more about the Pharmalys GCLP Accreditation Scheme and how the process works by visiting our website.
Pharmalys extends sincere thanks to the Proteome Sciences team for their professionalism and hospitality during the audit and congratulates them on another strong year of GCLP performance.
