Heparin concerns emerge once again as Chinese firm fails EDQM inspection

By PharmaCompass

2018-11-29

Impressions: 158 Article

A crude heparin sodium producer in China — Yibin Lihao Bio-technical Co, Ltd — was inspected by the FDA and was found to comply with good manufacturing practices (GMPs) in 2011 and 2014.

However, an inspection by the Italian Medicines Agency last month uncovered serious GMP non-compliance at the manufacturer. The inspection found 24 GMP deficiencies of which seven were classified as major. The inspectors raised concern over the risk of contamination. They also raised concern over the plight of the buildings, equipment, storage and traceability of starting material, process as well as recovery of solvents.

‘The Statement of Non-Compliance with GMP’ recommends that marketing authorization holders remove the site and prohibit the supply of crude heparin sodium from it.

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