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

A recent EU Non-Compliance Report ("Statement of Non-Compliance with GMP") issued by the Norwegian Medical Products Agency to Everest Organics Limited in India, a manufacturer of Omeprazole, is based on 18 deficiencies made (nine classified "major" and nine classified "minor") and was leading to the suspension of the respective CEP by EDQM.

And this list reads like a "best of" - or should we say "worst of" - the EU-GMP Guide. The first "major" deficiency attests a "lack of QA oversight, insufficient knowledge of the current requirements of EU GMP". Further findings classified as "major" are around:

• Ineffective measures of quality risk management
• Flaws in managing deviations, investigations of deviations, complaints, out of specification/out of trend results and identification of corrective and preventative actions (CAPAs)
• Insufficient system for handling changes
• Deficient system for evaluation and approval of suppliers
• Production buildings with outdated infrastructure and design, failing to meet GMP standards
• Insufficient equipment cleaning and maintenance
• Inappropriate storage locations/conditions
• Lack of systematic approach to properly identify and label some of the materials
• Risk of breaches in data integrity and lack of control of computerised systems

As a result, the authority proposed to the EDQM suspending or voiding the CEP. The EDQM has now suspended CEP 2014-035/Omeprazole.