Eudra GMDP lists Everest Organics and Akriti Pharma for EU GMP Non Compliance; CEP suspended

Everest Organics Ltd (Telangana, India) was issued a GMP Non-Compliance Report with recommendation to suspend the CEP certificate for Omeprazole, by Norwegian Authority. The NCA report followed an inspection in February 2024 at its Sangareddy, Telengana site in which major deficiencies with respect to Lack of Quality oversight, Outdated Infrastructure and buildings, Insufficient Cleaning & Maintenance of Equipment, Insufficient storage facility and storage conditions, Lack of Control of Computer systems, Risk of Data Integrity breaches were observed. The NCA report also highlights major lapses in Quality Management system processes in handling Deviations, Investigations, Complaints, OOS, CAPAs, Changes and Supplier Qualifications. Further CEP 2014-035/Omeprazole held by Everest was suspended by EDQM on 3 April 2024.

In the case of Akriti Pharmaceuticals (Pune, India) the GMP Non-Compliance Report was issued by the Malta regulatory authority following an inspection in April 2024. The NCA report was issued with a recommendation to EU Member states to reconsider reviewing any marketing authorisations, till the Statement of Noncompliance remains in place. During the inspection, inspectors observed 3 Critical and 5 Major issues and 17 other issues. The NCA report highlights issues including Ineffective Quality Management System (QMS), Data Integrity issues, Unreliable stability studies, Deficiencies in analytical testing and Lack of control of cross contamination measures. The onsite inspection in April 2024 was a follow up inspection after an offsite inspection in February 2022 had observed 5 Major deficiencies and 22 other issues.

Link to EudraGMDP Database