EMA/EDQM inspection found 24 GMP violations at heparin manufacturing in China

| By | Drug Quality Control, GMP Inspectorate

Yibin Lihao Bio-technology (Sichuan, China) 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.

According to the statement from a joint EMA/EDQM inspection the major deficiencies were found in the next areas: Risk of contamination, Buildings and facilities, Equipment, Storage of starting material, Process, Materials management, Traceability of starting material, Recovery of solvents. 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 European Directorate for the Quality of Medicines & HealthCare (EDQM) is a Directorate of the Council of Europe that committed to achieving harmonisation of the quality standards for safe medicines throughout the European continent and beyond. The EDQM’s standards are published in the European Pharmacopoeia, which is recognised as a scientific benchmark worldwide and is legally binding in member states.

SOURCE: raps.org
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