The QMN Weekly Bulletin
Pharmaceuticals / Inspections and Audits

Chinese Drugmaker Slammed By France for GMP Issues

April 22, 2016

Heparin is back in the news, after France’s National Agency for Medicines and Health Products Safety issued a GMP noncompliance statement to China’s Dongying Tiandong Pharmaceutical, which manufactures the active ingredients of Lovenox and Heparin.

According to the statement, 10 deficiencies were observed during the inspection, two critical and three major. One critical deficiency involved polymerase chain reaction results of crude heparin that showed the presence of manipulated ruminant DNA. In addition, the quality system for ensuring full traceability of crude Heparin was “very weak.”

The company also was dinged for not understanding basic GMP principles for the handling of out-of-specification results and deviations. The statement cites seven batches of crude Heparin that were OOS for potency.

ANSM also chided the company for its process for evaluating new suppliers of crude heparin. Further, the assessments of 1 H NMR spectrum (heparin sodium) and 13 C NMR (enoxaparin sodium) used for identification testing were deficient, according to the statement.

Based on the investigator’s findings, ANSM is considering a recall of products from the plant.

Word of the findings comes roughly nine years after contaminated Heparin led to a number of adverse events, including deaths, in the U.S.

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