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

The company was not deemed compliant with EU GMP standards. The Pharmaceutical Quality System was found inappropriate in order to ensure the corrective and effective application of GMP during the manufacture of the finished products and the complete traceability of materials and production steps. A high number of lacks were found in cleaning and maintenance operations in the production and storage areas and there were several gaps in traceability at different steps of product lifecycle. In addition to that, managerial responsibilities were not clearly defined. After the inspection carried out in February 2024, the Company did not put in place an adequate PQS to remove deviations and many of them were also raised during the inspection in June 2024. Inspection Outcome: Besides 9 deviations raised in the previous inspection (7-9 February 2024) and not removed, 14 major deficiencies (and 2 other deviations) were identified during the inspection carried out in 18-20 June 2024. These related to the following areas/activities: 1) Pharmaceutical Quality system was not adequate 2) No holistic approach in CAPA plan submitted from the previous inspection 3) Lack of traceability of 900 kg (equivalent to 18 drums) of pancreatin finished product 4) Replacement of environmental monitoring sheet 5) Uncleaned crude area for AS production 6) Ineffective pest control 7) Poor maintenance of equipment and facilities 8) Lack of traceability in maintenance plans 9) Uncontrolled documents (i.e. logbook) and unblocked excel sheets 10) Approval of production steps before having the results of CIP 11) Cleaning between different campaign not performed 12) Unidentified BR for no pharma use 13) Lack of reconciliation of materials after transfers 14) Warehouse logbooks inadequate to trace the materials Action taken/proposed by the NCA: Suspension of the manufacturing authorisation No. aM103/2023 in Full Recall of batches already released The competent Authority of Italy deems not to recall the batches of (bulk) finished products already distributed. Each involved NCA should evaluate following assessment conducted in conjunction with MAHs if a recall of medicinal product is needed. Prohibition of supply Restrictions on supply: shortage of medicinal products containing Pancreatin manufactured by Terhormon SpA is considered a real risk. Lack of alternative suppliers and risk of shortage should be assessed case by case. Each involved NCA should evaluate following assessment in conjunction with MAHs to recommend a full retest of the medicinal products manufactured by Terhormon SpA before using for further processing. In case of failure the Supervisory Authority has to be informed.