Lack of Quality Oversight: EU Non-Compliance Report issued to Omeprazole Manufacturer

The Norwegian Medical Products Agency issued a recent EU Non-Compliance Report to Everest Organics Limited in India, a manufacturer of Omeprazole, citing 18 deficiencies, with nine classified as "major" and nine as "minor." These shortcomings led to the suspension of the corresponding Certificate of Suitability (CEP) by the European Directorate for the Quality of Medicines (EDQM).

The identified deficiencies encompass various aspects of EU-GMP compliance. Major issues include a lack of Quality Assurance oversight and inadequate knowledge of current EU GMP requirements, ineffective quality risk management, deficiencies in managing deviations, complaints, and corrective actions, inadequate systems for handling changes and evaluating suppliers, outdated production building infrastructure, inadequate equipment cleaning and maintenance, improper storage conditions, deficient material identification and labeling systems, and risks of data integrity breaches and lack of computerized systems control.

Consequently, the Norwegian authority proposed suspending or voiding the CEP, leading to the EDQM's suspension of CEP 2014-035/Omeprazole.