Valpharma International S.p.A. — EU GMP NCR (EudraGMDP) Findings

The company manufactures exclusively non-sterile bulk products. Manufacturing activities were found to be non-compliant with EU GMP standards. The Pharmaceutical Quality System was deemed inadequate to ensure proper GMP implementation and full traceability of materials and production steps. Deficiencies were identified in the traceability of raw materials throughout the product lifecycle. Although management responsibilities were formally defined, an effective quality management system was not implemented. Inspection outcome: 11 deviations, including 3 classified as critical. Key findings include: 1) Raw materials stored in non-GMP areas/rooms. 2) Inconsistencies between the raw materials stored in non-GMP rooms and those reported in the BRs. 3) Senior management failed to implement an effective quality management system. 4) The ERP (SAP) information system does not track all the metadata necessary to ensure complete reconciliation and traceability of materials, raw materials, and excipients. 5) User logins within the scales are not properly tracked. 6) Some labels on the containers state "Technical Test." These activities are performed as part of the equipment qualification process or at the customer's simple request, making the conformity of the qualifications performed and/or the established frequency unreliable. 7) The qualification of some equipment (e.g. CD4 automatic coating machines) of the production equipment was not carried out in accordance with Annex 11. Action taken/proposed by the NCA: Suspension of the manufacturing authorisation No. aM-14/2025 in Full Withdrawal, of current valid GMP certificate No. IT/21/H/2025 Restriction of current valid GMP certificate No. IT/21/H/2025 Recall of batches already released Market actions should be determined by each Member State based on QRM principles to avoid market shortages. Furthermore, marketing authorization applications, line extensions, or variations to existing marketing authorization applications should not be authorized at this time. Prohibition of supply The shortage of Valpharma medicinal products is not considered a real risk. The lack of alternative suppliers and the risk of shortages must be assessed on a case-by-case basis. Others This manufacturer should not be authorised in any new/ongoing marketing authorisation or variation applications for medicinal products as long as the non- compliance statement is in force.