Documentation / Records

EMA updates batch-number guidance for parallel-traded medicinal products

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EMA updated its GMP/GDP Q&A on 21 October 2026 concerning batch numbers on medicinal products relabelled or repacked for parallel trade. The Q&A states that applicable national legislation or guidance should be followed. Where none exists, the outer packaging should carry one batch number allocated by the parallel trader, ideally combining the original batch number with a unique repackaging or relabelling code. Traceability between original and additional numbers must be documented. If separate numbers are used, both must appear in recall information. A completely different parallel-trader batch number is strongly discouraged and requires justification and supervisory-authority authorisation.

FDA Warning Letter: Sterility, Component Testing, and Quality Unit Deficiencies at Jiangmen Shuizirun

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FDA states that its November 3–7, 2025, inspection of Jiangmen Shuizirun Sanitary Articles found significant CGMP violations in OTC drug manufacturing. Several products were labeled “sterile,” although they were not sterilized, the certificates of analysis did not claim sterility, and the firm did not perform release sterility testing. One released batch had a reported aerobic microbial count, which FDA said was unacceptable for a sterile-labeled drug. FDA also found inadequate identity and impurity testing for incoming components and purchased in-process materials, including high-risk ingredients, while supplier certificates were relied upon without establishing their reliability. The quality unit did not adequately oversee documentation, written production procedures, process and system validation, stability testing, or finished-product testing. FDA additionally noted that the same batch number was assigned to different products, and that neither the firm nor its U.S. Agent responded to FDA’s attempts to discuss recalling sterile-labeled products in U.S. distribution.

FDA cites CGMP violations at Jiangmen Shuizirun OTC drug facility

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FDA issued a warning letter to Jiangmen Shuizirun Sanitary Articles Co., Ltd. after a November 2025 inspection of its Chinese OTC drug manufacturing facility identified significant CGMP violations. FDA stated that products labeled “sterile” were not sterilized, lacked release sterility testing, and were assessed against microbial limits unacceptable for sterile drugs. The agency also cited inadequate identity and impurity testing of incoming components, reliance on supplier certificates without establishing reliability, and deficient quality-unit oversight of documentation, process validation, procedures, stability, and finished-product testing. FDA additionally identified non-unique batch numbering, recommended removal of within-expiry sterile-labeled products from the U.S. market, and noted that the firm’s drugs were placed on Import Alert 66-40.

FDA Warning Letter: SCA Pharmaceuticals cited for aseptic processing and contamination-control deficiencies

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FDA states that its October 20–30, 2025, inspection of SCA Pharmaceuticals’ Little Rock outsourcing facility found serious deficiencies in production of drugs intended or expected to be sterile. Investigators cited inadequate certification and dynamic airflow visualization of ISO 5 areas, airflow and HEPA-supplied positive-pressure concerns, poor aseptic practices, deficient material disinfection, and environmental monitoring that was not representative of production conditions. FDA also found inadequate evaluation of microbial contamination in ISO 5 areas and insufficient investigations, CAPA, and batch-impact assessments. Component and visual inspection controls did not adequately identify, classify, investigate, trend, or address particles and foreign material between syringe stopper ribs. Laboratory controls and Quality Unit procedures were cited as inadequate. Production videos used in investigations were overwritten after approximately a redacted period, with only still images retained. FDA found some responses deficient and could not fully evaluate others because supporting documentation was inadequate, and recommended a comprehensive aseptic operations assessment assisted by a qualified sterile-manufacturing consultant.

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 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.

FDA Warning Letter: Inadequate Testing, Process Validation, and Quality Unit Oversight at TCI BioCosme

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FDA states that its March 2026 inspection identified significant CGMP violations in the manufacture of OTC drug products. The firm released U.S.-market batches without finished-product assay testing for the active ingredient, and its quality system did not ensure that required tests were identified, documented, and completed. FDA also observed inadequate identity testing of incoming APIs and raw materials, reliance on supplier certificates of analysis without establishing their reliability, and failure to perform applicable USP monograph tests. Manufacturing processes were not adequately validated: a validated process differed from the batch record, and validation for one product was used to support another product with a different process. Qualification and monitoring of a component used in products and equipment cleaning lacked specified chemical and microbial testing and defined microbial limits. FDA further cited inadequate quality unit oversight, including undocumented process-parameter changes, deficient batch records, and the absence of a written stability testing program. FDA found the firm’s Form FDA 483 response inadequate because it lacked sufficient supporting documentation and evidence of corrective actions.

PIC/S Revises GMP Guide Annex 19 on Reference and Retention Samples

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PIC/S revised its GMP Guide for Medicinal Products to version PE 009-18, incorporating the revised Annex 19 on reference and retention samples. The revision primarily concerns Section 9, addressing samples for parallel imported, parallel distributed, and parallel traded products. A note specifying that Section 9 applies only where these activities are covered by local legislation has been retained. The PIC/S Committee adopted the revision by written procedure on 22 September 2026. PE 009-18 enters into force on 24 September 2026, coinciding with the revised EU Annex 19. Non-EEA PIC/S Participating Authorities and Applicants have been invited to transpose Annex 19 into their GMP Guides.

EMA reports on international API inspection programme, 2017–2024

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EMA’s report reviews the International API Inspection Programme from 2017 to 2024. Across 13 participating authorities, information was shared on 936 inspected sites and 1,684 inspections, approximately 50% more inspections than in the previous period. Of the sites, 644 (69%) were of shared interest; inspection reliance was reported for 107 sites. Authorities conducted 91 remote inspections, while 27 joint inspections covered 25 sites. Duplicate inspections affected 32% of sites and were more frequent following non-compliant outcomes. The report identifies legal, confidentiality, language, technical and resource barriers to report sharing and centralised data exchange. It recommends timelier information sharing, improved report usability, stronger reliance practices and action on duplication.