The QMN Weekly Bulletin
Pharmaceuticals / GMPs

ANSM Says Chinese Drugmaker Falsified GMP Documents

July 28, 2017

France’s Agency for the Safety of Health Products cited Chinese API manufacturer Chongqing Succeway Pharmaceutical for GMP non-compliance, including one critical finding — active tampering with company data.

An agency inspection identified more than 20 deficiencies at the company’s Chongqing facility. Inspectors found the company manipulated, backdated and falsified major GMP documents, including batch records and reports of manufacturer audits of starting materials.

The agency also found the facility had an undeclared workshop and was storing unidentified, untraceable products.

The company manufactures the active ingredient rilmenidine dihydrogen phosphate, which is used in anti-hypertension drugs marketed under various brand names.

ANSM recommended a recall of batches already released and said no products from the facility should be used in drug compounding or in marketing authorizations until the non-compliance issues are resolved.

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