General Administration to increase the bio-chemical raw materials flying inspection efforts Longyuan Pharmaceutical GMP certificate was withdrawn

On September 18, the State Food and Drug Administration issued a notice, flight inspection found that Jilin Governor Yuan Pharmaceutical Co., Ltd. in the production of cerebral peptide capsules, compound pyrotein hydrolysate tablets in violation of the "People's Republic of China Drug Administration Law" and the relevant provisions of the drug GMP, decided to seal the inventory of drugs, withdraw the enterprise drug GMP certificate, ordered the recall of products sold, illegal production of enterprises to investigate. A spokesman for the General Administration of Food and Drug Administration pointed out that there are current problems in the supply chain management of raw materials in individual biopics enterprises, on the one hand, to speed up the research and formulation of relevant production norms, on the other hand, we need to further strengthen supervision and inspection, and further urge enterprises to continue to compliant production. Bio-pharmaceutical enterprises must attach importance to the audit of upstream raw material suppliers, strengthen supply chain management, and effectively assume the responsibility of the main body of drug quality.
In accordance with the work of deployment, in mid-June, the General Administration organized a random inspection of bio-chemical drugs found that a production enterprise after the extraction of ingredients also flowed to Jilin Province Changyuan Pharmaceutical Co., Ltd. and other pharmaceutical production enterprises, the General Administration immediately decided to carry out extended inspection. After the company's production of cerebral peptide capsules, compound cerebral protein hydrolyte tablets and other flight inspection found that the enterprise has changed the pig brain extraction process, fabricating records, unauthorized use of pig brain residue directly feed and other illegal violations, in violation of the People's Republic of China Drug Administration Law and drug GMP-related provisions. The General Administration of Food and Drug Administration of Jilin Province is required to supervise enterprises to seal their stocks of brain peptide capsules, withdraw the enterprise's "Drug GMP Certificate", order enterprises to recall products sold, and open a case investigation into illegal and illegal production practices of enterprises.
, it should be noted that in recent years most enterprises have strengthened quality control of raw materials, strengthened supplier audits and supply chain management. However, there are individual pharmaceutical enterprises on the raw materials management did not pay enough attention to the supplier audit walked through the scene, did not establish a real supply chain quality control system. What's more, in order to save raw material costs there are changes in the process, record fraud, illegal feeding and other issues.
flight inspection is a warning and a spur to the whole industry, especially the bio-chemical and chemical production enterprises. (State Administration of Food and Drug Administration)