MEHTA API Pvt. Ltd. — EU GMP NCR (EudraGMDP) Findings

The inspection was carried out in the framework of the EDQM inspection programme on 9 - 11 September 2019. Scope of the inspection was Erythromycin. In total 24 deficiencies were identified by the inspection team, eleven as major and one as regarding compliance with CEP dossier. The observation regarding CEP dossier was related to usage of regenerated solvent (dichloromethane) which is not included form the current dossier version. The major deficiencies were identified in most of the GMP areas with regards to change control, computerised systems, material management traceability, buildings and facilities, clean areas, cleaning validation, suppliers´ qualification, deviations, CAPA, purified water system, CoAs issuance and standards usage. The company had been subjected to 3 previous inspections, these inspections had defined similar issues as were observed during current inspection indicating a lack of QA oversight and inadequate approach with regard to addressing the issues identified during GMP inspection. Based on the number and severity of the major observations, the inspector team concluded that the inspected firm cannot be considered as in compliance as in compliance with EU GMP Part II and that the combination of deficiencies identified constitutes a critical risk of production products which could be harmful to the patient. Action taken/proposed by the NCA: Requested Variation of the marketing authorisation(s) This manufacturer should not be authorised in any new/ongoing marketing authorization or variation application. The submission of a variation application for introducing alternative manufacturers of the active ingredient is recommended. Recall of batches already released A recall of medicinal products should be evaluated by involved NCAs following the assessment. Prohibition of supply Prohibition of supply of Erythromycin is recommended, unless there are no alternative suppliers and there is a risk of shortage. Suspension or voiding of CEP (action to be taken by EDQM) Suspension or withdrawal of CEP is recommended.