What happened
Following inspections on February 10–12 and April 22–23, 2026, the Netherlands Health and Youth Care Inspectorate concluded that the hospital pharmacy was GMP non-compliant, citing one critical, seven major and fourteen other deficiencies. The critical deficiency concerned inadequate OOS handling: registered finished-product batches were released outside moisture or assay limits, and an ATMP was released despite a failed in-process sterility test. Major findings covered incomplete contamination controls, inadequate aseptic process simulations, deficient microbiological investigation and trending, poor cleanroom behaviour and gowning, and weaknesses in the pharmaceutical quality system, computerized system validation, data integrity and documentation. The NCA stated withdrawal of four current GMP certificates, including certificates for Plesmanlaan 121. A reinspection is planned but not yet scheduled; successful reinspection would support a new certificate and withdrawal of the non-compliance statement. For trial EU CT 2023-505039-11-00, the NCA assessed the impact as limited and left market decisions to concerned Member States; no trial suspension was reported.
Why it matters
The findings indicate that batch-release decisions may not have been adequately supported when specifications or sterility controls failed. Deficiencies in aseptic practices, contamination control, microbiological oversight and operator conduct may affect confidence in sterile manufacturing. Broader weaknesses in the quality system, computerized system validation, data integrity and documentation could also affect oversight of registered, investigational and advanced therapy medicinal products. The report limits cross-border impact to one clinical study and does not report a recall.
Key topics: Release of batches despite OOS moisture, assay or sterility results, Incomplete aseptic controls and inadequate process simulations, Withdrawal of GMP certificates and reinspection planned
Report details
- Report number: NL/H 26/2008484A
- EudraGMDP document reference: 187962
- Site: Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
- Country: Netherlands
- Inspection end date: 2026-04-23
- Issue date: 2026-10-07
Source: EudraGMDP – Statement of GMP Non-Compliance. Report number: NL/H 26/2008484A; document reference: 187962.