Non-Compliance at Chinese Heparin Manufacturer

Recommendation

16-18 November 2021

Control of Parenterals - Container/Closure Integrity Testing & Visual Inspection Systems - Live Online

A Non-Compliance Report has been issued to a Chinese heparin manufacturer after an inspection conducted on October 2018. During this inspection performed by the Italian Health Authority on behalf of EMA & EDQM, several violations of GMP were identified.

The company located in Sichuan manufactures crude heparin. In total, 24 GMP deficiencies were observed of which 7 were classified as major. Those major deficiencies were identified in the following areas:

• Risk of contamination
• Buildings and facilities
• Equipment
• Storage of starting material
• Manufacturing process
• Materials management
• Traceability of starting material 
• Recovery of solvents

In 2014 already, the US American health authority FDA had issued a Form 483 due to deviations observed during an inspection at this facility. The recent European report now recommends to prohibit the supply of crude heparin from this facility but not to recall already shipped batches. The inspection outcome will also have consequences on the CEPs concerned by EDQM.

The Non-Compliance Report (EudraGMDP No  51022) can be read on the EMA website for Non-Compliance Reports.