What happened
Following its 2026 inspection, the Netherlands Health and Youth Care Inspectorate found the hospital pharmacy GMP non-compliant for sterile, non-sterile, biological and packaging operations. The NCA recorded one critical, seven major and 14 other deficiencies. The critical deficiency concerned an inadequate OOS process: several registered finished-product batches were released outside moisture or assay limits, and an ATMP was released after a failed in-process sterility test; ambiguous procedures could permit certification without adequate investigation or justification. Major findings covered incomplete aseptic controls and contamination strategy, inadequate process simulations, weak microbiological test design, investigation and trending, operator and gowning deficiencies, an insufficient pharmaceutical quality system, inadequate computerized-system validation and data integrity, and poor documentation practices. For the sole EU-facing study, DS-8201a relabeling and repackaging, the NCA considered impact limited but said systemic deficiencies could affect it. It left market decisions to concerned Member States; no trial suspension was stated. The NCA withdrew four GMP certificates and plans an as-yet-unscheduled re-inspection. Positive re-inspection would permit recertification and withdrawal of the statement.
Why it matters
Releasing batches outside specification and an ATMP after a failed in-process sterility test raises direct concerns about batch disposition, OOS investigation and sterility assurance. The aseptic simulation, contamination-control, microbiological trending, operator practice and gowning findings may undermine confidence in controlled sterile manufacture. Broader weaknesses in the pharmaceutical quality system, computerized-system validation, data integrity and documentation could affect reliable oversight and records. For DS-8201a, the NCA said sterile-manufacturing findings did not affect relabeling and repackaging, although systemic weaknesses could do so.
Key topics: Release of registered products outside moisture or assay limits and an ATMP after a failed sterility test, Incomplete aseptic controls, process simulations and microbiological trending, Withdrawal of four GMP certificates with re-inspection planned but not yet scheduled
Report details
- Report number: NL/H 26/2008484B
- EudraGMDP document reference: 188001
- Site: Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
- Country: Netherlands
- Inspection end date: 2026-04-23
- Issue date: 2026-10-08
Source: EudraGMDP – Statement of GMP Non-Compliance. Report number: NL/H 26/2008484B; document reference: 188001.