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After N-Nitrosodimethylamine (NDMA) was discovered in Valsartan active substance coming from the Chinese API manufacturer Zhejiang Huahai, the product was recalled and the company's CEP for valsartan was suspended. The supply of the company's valsartan in the EU was prohibited. Now an inspection by the Italian Medicines Agency in collaboration with EDQM revealed significant GMP violations at Zhejiang Huahai's Chuannan site in Linhai, China. Nine "Major" and eight "Other" deviations were identified, like, for example, in the areas of - Investigations conducted in the context of the NDMA/NDEA contamination of Valsartan
- Risk assessment and control strategy implementation
- Complaint handling and recall management
- Reprocessing/blending operations
- Data integrity
As a result, a statement of non-compliance for the manufacture of valsartan has been issued and published on the EudraGMP website. EU marketing authorisation holders need to be aware that it is not allowed to use valsartan coming from this site for the production of medicines. The Italian Medicines Agency also recommends prohibiting the supply of Valsartan intermediates to the EU market. Furthermore, "the inspected manufacturing site is placed under increased supervision by EU authorities. As part of this measure the MIA holders will be requested to perform full specification testing on all future incoming batches of APIs received from the site. Furthermore, specific additional testing will be required for future incoming batches of "sartan" APIs". The US Food and Drug Administration (FDA) has also inspected the company and issued an import alert including all active substances produced by Zhejiang Huahai's Chuannan site and all medicines containing those APIs.
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