Technophage Investigacao E Desenvolvimento Em Biotecnologia S.A. — EU GMP NCR (EudraGMDP) Findings

During the inspection were identified 3 critical findings, 5 major findings and 2 findings classified as others. As critical deficiencies were identified: • Inoperability of the production area and lack of access control to quality control/production, namely: - Inoperability of the production area, which was under renovation, without any equipment inside, without any communication to the Competent Authority. - Lack of access control to quality control/production, with the possibility of entry of people not belonging to the manufacturing unit being identified from the access hall to the bathroom of the manufacturing and quality control area. • Many of the data/records intended to prove the quality of the products produced proved to be inconsistent, confusing, incomplete, and therefore compromised the correct traceability of the products and materials, namely: - CoA No º 004/2025, BM0738.24001, Working Cell Bank _STA 75/12, dated 10/01/2025, was not signed by the Quality Control Officer and contained inconsistent dates (analysis 01/04/2024, manufacture 27/08/2024) and which also did not correspond to the date of the batch manufacture (25/03/2025 to 27/03/2025). - Logbook records were not always complete, correct and/or made at the time the activities were carried out, and several deficiencies were identified. •In the batch documentation BPR – 081 relating to batch FP 0481- 25001 of TP-122 PSA Cocktail there were pages not numbered and on those that were numbered, the numbering had been handwritten. As major deficiencies, were identified: •The procedures, records and other documents of the quality management system were not always complete, described the activities in full or were correct: - The list of drug substance and drug product produced batches was not up-to-date with regard to the manufacture and approval dates and an incorrect date was identified (date of manufacture of batch No º BM0738.24001 of Working Bank Cell _STA 75/12). - EMM Rooms CL2 (AL0.09, AL0.10, AL0.15, AL0.16, AL0.17, PB0.30, PB0.31) did not cover all the locations to be sampled on the isolator for environmental monitoring. - Deficiencies were identified in manufacturing instructions and batch records, namely incomplete manufacturing instruction (BPR-088, TP-102-DP1 Cocktail FP0607, batch FP0607.25001), as well as failure to record specifications and results (batch documentation IP 0420.25002) and the existence of many erasures in batch documentation FP0481.25001 of TP-122 PSA Cocktail FP0481 (BPR-081). •Logbook entries were not always made completely, correctly and/or at the time the activities were carried out, and it was identified in the Double Agar Overlay Assay Bacteriophage titer logbooks that the meaning of the compliant result for negative control was not identified (logbook nr. 282), as well as results from 08/07/2025 that had not yet been verified (logbook n.º 287). •Use of drug substance batches in the manufacture of finished product without having drug substance CoA nor batch analysis results (e.g. batch IP0420.25002 of Phage 99/10). •Information lacks were identified in the warehouse activities: - In the record of receipt of batch 25267 of RE0788-Bocto Red Time PCR_quarentena of 23/10/2025 was not identified whether the material was in the refrigerator or at room temperature (only QC was mentioned). - There was no easily accessible inventory that would allow verification of the quantities of each drug substance or drug product found in EQ084 (warehouse refrigerator). - In document SOP-001-FR-002, receipt of materials checklist for DP0069, batch 25270, the status was referred to as NA when it should have been Quarantine, and the verification of the manufacturer's name and address was not included (only the supplier's). • No evidence was presented for sterilization cycle 841, relating to the sterilization of the material (lot FP0481. 25001), which would contain information on the preparation of the material to be sterilized. Action taken/proposed by the NCA: Suspension of the manufacturing authorisation No. F068/001/2024 in Part Withdrawal, of current valid GMP certificate No. F068/S1/ME/001/2024 Withdrawal, of current already expired GMP certificate No. F068/S1/ME/001/2024. Recall of batches already released Each NCA should evaluate and assess the need of recall of the impacted batches. Prohibition of supply The manufacturer is prohibited to manufacture and supply Human Investigational Medicinal Products. Others Suspension of the manufacturing authorisation No. F068/001/2024 regarding Human Investigational Medicinal Products (ANNEX 2) - ANNEX 2 of the Manufacturing authorization is no longer valid.