EU GMP Non-Compliance

EU GMP Non-Compliance (4 reports published for the same company- see previous posts): Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting – inadequate OOS and aseptic controls

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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.

EU GMP Non-Compliance: Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting – Inadequate OOS controls and release after failing results

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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.

EU GMP Non-Compliance: Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting – Inadequate OOS handling and aseptic controls

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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.

EU GMP Non-Compliance: Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting – inadequate OOS handling allowed release of non-compliant batches

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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.

EU GMP Non-Compliance: Ocb Pharmaceutical S.R.L. – relabelling and distribution obscured bismuth subsalicylate supply-chain traceability

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Following an inspection ending 27 August 2026, the Spanish NCA identified nine deficiencies: one critical and eight major. The critical deficiency concerned repackaging and relabelling bismuth subsalicylate from a Chinese manufacturer operating outside the EU GMP framework. OCB assigned new batch numbers, copied supplier results into certificates of analysis, replaced or removed original labels, and distributed material without adequately preserving manufacturer identity and supply-chain traceability. Major deficiencies affected investigations, CAPA, risk management, data integrity, personnel qualification, materials traceability, contamination controls, cleaning, facilities, documentation and quality oversight. The NCA temporarily suspended all API and intermediate manufacturing at Canovelles and suspended distribution and sale of material manufactured, repackaged or relabelled there, pending correction and verification through reinspection. No recall was considered necessary because no specific defects in marketed batches were detected. The NCA said suspension of the site’s bismuth subnitrate CEP should be considered. It also withdrew the current GMP certificate and recommended justified testing by customers, alternative qualified sources, and exclusion from new or ongoing applications while the statement remains in force.