Eugia Pharma Specialities Limited — EU GMP NCR (EudraGMDP) Findings

A follow up inspection was conducted on 25–27 February 2026 to verify the implementation of corrective actions from the previous inspection and to assess the current state of GMP compliance at the manufacturing unit responsible for producing the Meropenem active substance. Several critical deficiencies previously identified remained uncorrected, and additional critical and major deficiencies were observed, collectively demonstrating that the quality of the active substance is compromised and leading to the issuance of this NCR. Critical deficiencies from the previous inspection persisted. Glove integrity checks on the mobile LAF (PB/LAF23) were not performed consistently during operations, despite video evidence showing occasional verification. The LAF and RABS doors in room PB032 showed degradation and breaches, failing to ensure segregation between cleanroom grades. Furthermore, no monitoring of pressure differentials between Grade A and Grade B was in place, as the manometer measured only blower to filter pressure, leaving no evidence of appropriate environmental control in this critical area. Additional critical deficiencies were identified. The risk assessment QRM/EU2/061/2025 did not evaluate the need for revalidation of the Meropenem API manufacturing process following the installation of new RABS and modification of the filling line layout. Material and component transfer into Grade A/B areas was not demonstrated to follow a unidirectional and continuous process, as the mobile LAF was removed mid operation to retrieve additional containers, contradicting the company’s previous CAPA commitments. The cleaning of the filling line bin in PB032 was performed inside the room using a non closed, non automated process, with excess water drained into a bucket placed in front of the RABS, posing a significant contamination risk. Several major deficiencies were also identified. Change controls were not classified according to criticality, including those previously deemed critical. Procedures lacked clarity regarding definitions, responsibilities and operational steps, including the Change Control SOP and the SOP governing fingerprint access authorisation. The risk assessment did not clearly determine whether updates to the Batch Manufacturing Record were required. In Quality Control, no complete and updated analyst qualification matrix was available. Analyses assigned in LIMS to one analyst were performed by another, indicating non compliance with work allocation. QC logbooks lacked traceability and sequential documentation, with missing audit trails for key activities. Equipment status identification was inconsistent with LIMS records, and calibration responsibilities were not aligned with defined procedures. In the microbiology laboratory, an environmental monitoring sample was not provided in a timely manner, and critical temperature monitoring points in incubators were not identified. Maintenance of technical areas and utilities was inadequate. Replacement filters were stored in damaged and dirty boxes; ducts and insulation associated with AHU28 were degraded; the pre filter cleaning station and RO water pipe showed dirt and corrosion; and the pre filter inside AHU028 supplying PB32 appeared dirty despite recorded cleaning. Overall, the persistence of unresolved critical deficiencies, combined with newly identified critical and major findings, demonstrates a failure to ensure the required level of control for sterile API manufacturing. These deficiencies compromise the quality of the Meropenem active substance produced at this unit and justify the issuance of this NCR. Action taken/proposed by the NCA: Prohibition of supply Due to the number and severity of the deficiencies identified, the supply of finished products manufactured with the Meropenem active substance produced at Eugia Unit II should be prohibited. Portugal will conduct a full identification of all medicinal product batches containing Meropenem API manufactured at this unit, in order to proceed with their recall.