Everest Organics Limited — EU GMP NCR (EudraGMDP) Findings

During this inspection 18 deficiencies were identified in total, nine classified as major and nine classified as “other”. D1[Major]: A lack of QA oversight, insufficient knowledge of the current requirements of EU GMP and ineffective measures of quality risk management applied to activities with GMP impact, D2[Major]: The production buildings showed signs of outdated infrastructure and design, compromising the suitability for manufacturing activities. The facility lacks modernisation and fails to meet the standards as per current EU GMP guidelines, D3[Major]: Insufficient equipment cleaning and maintenance, D4[Major]: Inappropriate storage locations/conditions within the facility including insufficient storage capacity, traceability and accountability, D5[Major] Lack of systematic approach to properly identify and label some of the materials, with a risk of mix-up during storage and manufacture, potentially leading to product quality issues or contamination, D6[Major] Risk of breaches in data integrity and lack of control of computerised systems, D7[Major] The systems for managing deviations, investigations of deviations, complaints, out of specification/out of trend results and identification of corrective and preventative actions (CAPAs) presented some flaws, D8[Major] The system for evaluation and approval of suppliers of materials was found to be deficient, D9[Major] The system for handling changes, including the procedures for the introduction of new chemical entities, was found to be insufficient. Action taken/proposed by the NCA: Suspension or voiding of CEP (action to be taken by EDQM) CEP 2014-035/Omeprazole was suspended by EDQM 3 April 2024.