Chinese Heparin Manufacturer Receives Statement of GMP Noncompliance

Regulatory NewsRegulatory News | 27 November 2018 |  By 

Sichuan, China-based Yibin Lihao Bio-technology Co. earlier this month received a statement of noncompliance with good manufacturing practices (GMP) from the Italian Medicines Agency.

The statement followed an inspection at the firm’s crude heparin manufacturing site on 31 October 2018. The extraction of substance from animal sources, certain physical processing and packaging steps and biological testing were found to be noncompliant.

The inspection identified 24 GMP deficiencies, of which seven were categorized as major.

“The major deficiencies were found in the following areas: 1. Risk of contamination; 2. Buildings and facilities; 3. Equipment; 4. Storage of starting material; 5. Process; 6. Materials management, traceability of starting material; 7. Recovery of solvents,” the statement said, noting it was a joint EMA/EDQM inspection.

While the statement does not recommend any recalls, it is recommending a prohibition of supply of crude heparin sodium manufactured by the site. The site also received a Form 483 from the US Food and Drug Administration (FDA) back in March 2014.

The statement of noncompliance follows concerns raised earlier this year on conflicting data on the US supply of the lifesaving drug heparin. In the letter, the congressmen ask FDA to look into whether the US supply of Chinese heparin is increasing or decreasing, and whether the fluctuation could raise the risk of adulterated heparin making it onto the US market. 



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Tags: EMA, GMP, heparin

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