Navesta Pharmaceuticals (Pvt) Ltd. — EU GMP NCR (EudraGMDP) Findings

An onsite GMP follow-up inspection was conducted after a very first inspection conducted in January 2025 following an application received by the company (Navesta Pharmaceuticals Private Limited), to assess compliance with EU GMP guidelines. The company did not bear an EU GMP certificate as it was their first application. During the onsite follow-up inspection performed between 16th – 21st April 2026, the inspectors observed 1 Critical, 5 Major and a total of 19 Other issues. The critical finding related to gowning procedures and changing room design, room finishes and installations in Grade B areas, environmental monitoring programme and poor aseptic practices. It was observed that the overall design, implementation, control and maintenance of the classified areas and the execution of critical aseptic processes were not adequate to ensure an appropriate level of sterility assurance, as the gowning systems, changing room design and personnel flows did not provide effective segregation between unclassified, lower-grade and higher-grade areas and allowed the potential transfer of contamination into Grade C, B and A environments. Grade B areas were equipped with unsuitable and degraded finishes and installations, including particle‑ and fibre‑shedding materials, damaged surfaces and exposed components, which were not compatible with the intended cleanroom classification and represented a direct risk to the controlled environment. The environmental monitoring programme was not sufficiently robust to identify, assess or control the risks associated with critical aseptic operations, owing to the absence of monitoring during key aseptic activities, deficiencies in the installation and positioning of monitoring equipment, an inadequately justified sampling strategy and the lack of regular scientific review of alert and action limits. Furthermore, it was observed that aseptic practices during routine operations were inadequate, as sterile components were handled and transferred in a manner that compromised contamination control, and unidirectional airflow protection was not consistently maintained. Five “Major” findings were identified related to qualification and control of gowning and garment cleaning processes, Contamination Control Strategy, management of Aseptic Process Simulations, Suppliers Approval system and management of the Quality Control laboratories. 19 findings which were classified as “Others” were also identified. As a result of this outcome, the Inspection Review Group (IRG) at the Malta Medicines Authority has met and decided that a Statement of Non-Compliance with the principles and guidelines of Good Manufacturing Practice laid down in Directive (EU) 2017/1572 is to be issued for the site. Action taken/proposed by the NCA: Prohibition of supply Member states should consider whether review of any current active marketing authorisations is necessary and should consider not initiating or authorising new marketing authorisations with this site listed as a finished product manufacturer until the recommended non-compliance statement to be issued remains in place.