Aculife Healthcare Private Limited — EU GMP NCR (EudraGMDP) Findings

The inspection resulted in a critical deficiency on inadequate cleaning validation as well as eight (8) major findings. These dealt with inadequate control of identification labels inside the manufacturing area, inadequate management of visual inspection activities, sterilized product passing through an area where un-sterilized bags were waiting to be autoclaved, inadequate container closure integrity testing and delayed action to correct this very long standing issue, process validation inadequacies, deficient complaint management, deficient management of aseptic process simulations as well as insufficient qualification of manufacturers and suppliers of critical starting materials and no reassurance that primary packaging materials for ophthalmic products were free from contamination. There were also 24 other deficiencies, in addition to the critical and major findings. All these observed deficiencies raise concerns that the approach to the manufacturing of sterile products is not adequately managing inherent risks pertaining to sterile processes and is not in line with applicable EU GMP requirements. 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 EU Good Manufacturing Practice is to be issued for the site. Action taken/proposed by the NCA: Prohibition of supply No products batches manufactured at the site should be released to EEA markets until this noncompliance remains in place or is superseded by an EU GMP certificate. Others Member states 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a finished product manufacturer until the recommended non-compliance statement to be issued remains in place or is not superseded with a GMP certificate. The following applications are known to be ongoing: Sodium Chloride Intravenous Infusion – 0.9% w/v, nPVC bag 0.9% w/v Czechia (RMS), Germany (CMS), Spain (CMS) & Portugal (CMS) Ref. CZ/H/1558/001/DC Timolol 5 mg/mL Eye Drops Solution 5 mg/mL, 5 ml LDPE bottle Spain , Malta, Portugal, Hungary DCP slot requested in September 2025.