Current European Non-Compliance Report for an Indian API Manufacturer

Recommendation

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Major deficiencies observed during GMP inspections are entered into the EudraGMDP database. There, you can find a current Non-Compliance Report issued by the Italian Medicines Agency for the Indian API manufacturer Krebs Biochemicals & Industries Ltd.

The Non-Compliance Report covers the manufacture of the API Simvastatin, whereby not only the chemical synthesis but also the further processing of the API as well as the quality control are affected.

In total, 24 deficiencies were observed. Among them, five were classified as major but without further details:

• Deviation
• Personnel training
• Facilities
• Finish product storage management
• Production and monitoring of purified water

From the Authority's point of view, the combination of the findings and the weaknesses of the quality management system presented an intolerable risk to public health. Now, it is recommended that the national competent authorities evaluate on the basis of risk whether a recall of the medicinal products using the APIs concerned is necessary or not. It is also recommended to prohibit the supply of the API and to suspend the CEP (Certificate of Suitability of Monographs of the European Pharmacopoeia).

Source: EudraGMDP database