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Falsification and GMP Non-compliance again observed with Chinese Heparin Manufacturer

In 2008 adulterated Heparin from China caused the death of 81 people and 785 reports of serious injuries.A comprehensive investigation of the US congress identified weaknesses in the GMP Inspection by FDA. The US congress discovered that the frequency of inspections was not as required by FDA's internal standards. FDA took multiple actions as a consequence of the scandal.

The scandal led FDA to initiate a number of new regulatory initiatives. The Heparin scandal also impacted the EU regulations. The so-called Counterfeit Directive, the GDP Guidelines and changes in the EU GMP Guide (especially with regard to supplier qualification) have been heavily impacted by the Heparin case.Today manufacturers of medicinal products are obliged to control the GMP compliance of each API manufacturer.

Recently again heparin related non-compliance was found by the French Regulators at Dongying Tiandong Pharmaceutical Co., Ltd., No. 1236, Nan-er Road, Dongying City, Shandong Provice, China which came as a surprise to them.According to the non-compliance report published in the EudraGMDP Database following non-compliances were observed:

• PCR results of Crude Heparin showing the presence of ruminant DNA received from approved suppliers were manipulated. There was no evidence that the samples retested came from the same batch tested initially; (Critical)
• The quality system implemented by the company for ensuring the full traceability of crude Heparin was identified as very weak : e.g., the traceability from slaughterhouses/abattoirs was not available and not assessed during the audits of the suppliers (lack of supporting documents for the received lots)"(Critical)
• The inspectors also found out that 7 batches of crude Heparin received in 2014 and 2015 were obtained OOS for potency and used for the manufacturing of finished APIs without any OOS investigation.(Major)
• New suppliers of crude Heparin were not qualified in a systematic manner to guarantee the quality of the product.

As a consequence of the findings EMA published the GMP Non-Compliance Report on 25 February 2016. Also, the CEP 2005-258 was suspended. Manufactures of Medicinal Products using the Heparin from Dongying Tiandong Pharmaceuticals were asked to recall of their batches based on a risk assessment.



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