Ananta Medicare Limited — EU GMP NCR (EudraGMDP) Findings

During the inspection, multiple critical and major deficiencies were identified across the facility, particularly in areas directly associated with the aseptic manufacture of medicinal products. The nature and extent of these deficiencies demonstrate systemic weaknesses in contamination control, aseptic behaviour, equipment integrity, data governance, and quality control practices, which collectively pose a significant risk to the sterility, safety and overall quality of the products manufactured in Block A. Critical failures were observed in facility design and pressure cascade maintenance, including inadequate differential pressures between classified and non classified areas, reversed pressure gradients, and layout constraints that resulted in sterile API being exposed in Grade B. These issues undermine the fundamental environmental controls required for aseptic processing. Serious concerns were also identified regarding personnel behaviour and aseptic practices, with operators failing to comply with gowning requirements, aseptic discipline, RABS handling procedures, and environmental protection measures. Such behaviours directly compromise sterility assurance and indicate insufficient training and oversight. The inspection further revealed equipment in poor condition, including rusted pass box, unclean balance and step ladder, and the use of open containers for rejected materials and IPC samples within Grade B. These deficiencies represent unacceptable contamination risks within critical manufacturing areas. Significant weaknesses were found in the organisation and control of materials and GMP documentation, including the presence of operational documents, microbiology records, Petri dishes, and other materials stored in uncontrolled areas such as the expansion zone. The discovery of a deteriorated and unidentified gas cylinder connected to a pipeline used for aseptic filling further heightened concerns regarding uncontrolled substances potentially coming into contact with the product. Critical data integrity failures were identified, including missing records, inconsistent entries, unclear terminology, and analytical activities reported but not performed. These issues undermine the reliability of GMP documentation and raise concerns regarding the accuracy of batch release decisions. In the Quality Control laboratories, essential tests for APIs were not performed by the manufacturer, retention samples were improperly stored, finished product samples lacked proper identification, and sterility testing was conducted using unsuitable equipment. These deficiencies critically affect the validity of analytical results and the assurance of product quality. Major gaps were also identified in the Contamination Control Strategy (CCS), which was implemented late and failed to address several contamination risks, including API exposure in Grade B, environmental monitoring vulnerabilities, personnel limits, HEPA filter replacement rationale, and disinfectant approval. Finally, batch documentation lacked evidence of required sampling and incomplete line clearance verification, compromising batch traceability and readiness for aseptic operations. Action taken/proposed by the NCA: Others The Portuguese market is not impacted, as no medicinal products have been placed on the market by the manufacturer concerned, and alternative manufacturers with medicinal products containing the same active substance and strength are authorised in Portugal. It was decided that, for the manufacturer concerned, a Non-Compliance Report (NCR) was issued until all critical and major deficiencies have been adequately addressed and their implementation confirmed through a follow-up inspection.