Amara Labs Private Limited — EU GMP NCR (EudraGMDP) Findings

During this inspection 16 deficiencies were identified, classified as critical (1), major (9) and “other” (6). D1[Critical]: Insufficient knowledge of current EU GMP requirements, ineffective quality risk management measures applied and evident lack of QA oversight, D2[Major]: Failure to report a major production accident, D3[Major]: Evidence of data falsification, D4[Major]: Several GMP critical computerised systems in the QC laboratory lacked validation, D5[Major]: Significant deficiencies identified concerning design, conditions of facilities and equipment across all manufacturing areas, D6[Major]: Inadequate cleaning of manufacturing equipment, D7[Major]: No provisions in place to assess risks associated with manufacturing APIs and intermediates in shared facilities, D8[Major]: Inadequate approach to cleaning validation and not consistently applied to all products. D9[Major]: Insignificant process for handling changes, including procedures for introducing new chemical entities. D10[Major]: Insufficient evaluation of drying process activities carried out during process validation and technology transfer. Action taken/proposed by the NCA: Prohibition of supply The non-compliance affects all APIs and intermediates manufactured at the site. Therefore, no new MAs should be approved where APIs or intermediates from this site is used, as long as the non-compliance statement is active. In those cases where APIs or intermediates from this site are included in current MAs, the use of alternative suppliers should be considered. The recommendations are valid for all APIs / intermediates manufactured at the site since the nature of the findings is general and not specific to Irbesartan. Actions on Marketing Authorisations should be assessed by the respective licensing authority covering MAs which include APIs and intermediates manufactured by the inspected firm. Suspension or voiding of CEP (action to be taken by EDQM) CEP 2020-260 – Irbesartan Process II was suspended by EDQM April 29, 2024, as well as the other impacted CEPs associated with this site.