Maithili Life Sciences Private Limited — EU GMP NCR (EudraGMDP) Findings

During the inspection, 24 deficiencies against EU GMP were identified. Of these, based on a number of major EU GMP failures that could potentially lead to contamination/cross-contamination of the final APIs produced, and as a risk for the patient’s safety cannot be excluded, a general deficiency was raised as critical. The major GMP failures were observed in the areas of raw materials contamination/degradation and mix-up control, advanced intermediates contamination/cross contamination control, APIs contamination/cross contamination control, design, cleaning and maintenance of equipment, cleaning validation, change control management and quality risk management, deviation management, data integrity and quality control. Action taken/proposed by the NCA: Requested Variation of the marketing authorisation(s) It is recommended to assess the opportunity of requesting variation to the marketing authorisation in order to delete or substitute this manufacturer of active substances and intermediates. Recall of batches already released If there are alternative suppliers and there is no risk of shortage, recall of medicinal product should be evaluated by involved NCA’s following assessment conducted in conjunction with MAHs. Given the nature of non-compliances, assessment should include a complete retest of all imported batches of active substance. Prohibition of supply Due to the nature of the non-compliance prohibition of supply 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) CEP 2021-360 / Biperiden hydrochloride, CEP 2020-317 / Biperiden hydrochloride were suspended by EDQM December 25, 2024, and CEP 2022-168 / Sumatriptan succinate application was closed.