What happened
Following inspections on 10–12 February and 22–23 April 2026, the Netherlands Health and Youth Care Inspectorate found the hospital pharmacy GMP non-compliant. The NCA recorded one critical, seven major and 14 other deficiencies. The critical deficiency concerned an inadequate OOS process: multiple batches of registered finished products were released despite moisture or assay results outside specified limits, and an ATMP was released despite a failed in-process sterility test. The OOS procedure could permit certification and release without thorough investigation or sufficient justification. Major findings included inadequate aseptic controls, contamination control strategy, process simulations, microbiological investigation and trending, cleanroom behaviour and gowning. Weaknesses also affected the PQS, deviations, CAPA, change control, complaints, self-inspection, PQRs, computerized system validation, data integrity and documentation. The NCA’s stated action was withdrawal of four GMP certificates covering Plesmanlaan and Louwesweg. An unscheduled re-inspection is planned based on the company’s action plan. For the M22BOL study, the NCA described limited impact and left decisions to concerned Member States; no implemented suspension was reported.
Why it matters
The reported release of batches after out-of-specification moisture, assay or sterility results indicates that batch disposition and investigation controls may not have reliably prevented non-conforming product from release. Deficiencies in aseptic control, process simulation, microbiological oversight and operator practices may weaken assurance for sterile products and ATMPs. Broader PQS, computerized system, data integrity and documentation weaknesses could affect traceability, oversight and justified certification. The report describes limited EU study impact while acknowledging that systemic weaknesses could affect its relabeling and repackaging activities.
Key topics: Release of finished-product and ATMP batches despite out-of-specification results, Inadequate aseptic process simulations, contamination controls and microbiological oversight, Withdrawal of GMP certificates and planned re-inspection based on the company action plan
Report details
- Report number: NL/H 26/2008484D
- EudraGMDP document reference: 187964
- 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 26/2008484D; document reference: 187964.