What happened
The Netherlands Health and Youth Care Inspectorate found the hospital pharmacy GMP non-compliant after inspections on 10–12 February and 22–23 April 2026. The conclusion was based on one critical, seven major and 14 other deficiencies. The critical deficiency concerned an inadequate OOS process: several registered finished-product batches were released despite moisture-content or assay results outside specified limits, and an investigational ATMP was released after a failed in-process sterility test. The OOS procedure could also permit certification and release without thorough investigation or sufficient justification. Major findings covered incomplete aseptic controls and contamination strategy, inadequate process simulations, weak microbiological investigation and trending, operator and gowning practices, deficiencies across the pharmaceutical quality system, inadequate computerized-system validation and data integrity, and poor documentation practices. The Inspectorate withdrew current GMP certificates, including certificates covering Louwesweg 6. A re-inspection, not yet scheduled, is planned against the company’s action plan; a new certificate would follow a positive outcome. For study EU CT 2023-505039-11-00, the NCA considered impact limited and left market decisions to concerned Member States.
Why it matters
The findings call into question the reliability of batch disposition where failing OOS or sterility results were not adequately resolved. Deficiencies in aseptic control, process simulations, microbiological oversight and operator practices may affect confidence in contamination control for sterile registered products and ATMPs. Weaknesses in the quality system, computerized-system validation, data integrity and documentation may also affect traceability and oversight, including relabeling and repackaging for the cited EU trial. The report does not state that the trial was suspended; it says Member States should decide under their legal frameworks.
Key topics: Release of registered batches despite out-of-specification moisture or assay results, Investigational ATMP released after a failed in-process sterility test, Withdrawal of GMP certificates and planned re-inspection
Report details
- Report number: NL/H 26/2008484C
- EudraGMDP document reference: 187963
- 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 26/2008484C; document reference: 187963.