Xinhua News Agency, Beijing, June 6th (Reporter Chen Cong) The State Food and Drug Administration recently released the 2016 annual drug inspection report, marking an important change in the drug supervision and management model. Ding Jianhua, Director of the Department of Supervision and Administration of Food and Drug Administration, pointed out that the focus of drug supervision in the future will be further changed to the direction of supervision and inspection, "we consider exploring the integration of the two certificates of GMP certification and drug production license in the future. ', And strengthen supervision after the event ".
Ding Jianhua said in an interview with the media that the GMP certification of medicines has been decentralized to the provincial food and drug regulatory department. The General Administration will no longer accept GMP certification of medicines from January 1, 2016. Application, pharmaceutical GMP certification will no longer be the "protection umbrella" for enterprises.
Ding Jianhua said that drug GMP certification is a basic and inevitable requirement that drug manufacturers should follow in the production process. The drug production process should be carried out in accordance with the specifications, which is regulated by a continuous and dynamic process. He emphasized that ensuring "continuous compliance" is the primary responsibility of the company's production, and the Pharmaceutical and Chemical Supervision Department will increase inspections of companies and products to promote "continuous compliance".
"Pharmaceutical GMP certification is equivalent to issuing a five-year valid certificate for pharmaceutical companies. Even if the company does not manufacture according to the specifications, it will consider that there is a guarantee of government certification and avoid its own responsibilities." Ding Jianhua said that in the future, the form of pre-certification certification will be cancelled. After the supervision, it does not mean that the quality standards of medicines will be lowered, and pharmaceutical companies will face more stringent inspections, especially unannounced flight inspections.
According to the provisions of the Drug Administration Law, the establishment of a drug manufacturing enterprise must be approved by the drug supervision and administration department of the people's government of the province, autonomous region, or municipality directly under the Central Government and issued with a "Pharmaceutical Production License". Without the "Pharmaceutical Production License", no pharmaceuticals may be produced. Pharmaceutical production enterprises must organize production in accordance with the "Pharmaceutical Production Quality Management Standards" formulated by the Drug Supervision and Administration Department of the State Council in accordance with the Drug Administration Law.
At present, the GMP certification of pharmaceuticals implemented in China is implemented in March 2011 on the basis of referring to international standards. All enterprises and production lines that fail to meet the requirements are not allowed to produce, and are called "the strictest certification in history" by the industry. As part of the quality management system, pharmaceutical GMP is the basic requirement for pharmaceutical production and quality management. It aims to minimize the risks of contamination, cross-contamination, confusion, and errors in the production of pharmaceuticals, and ensure continuous and stable production in accordance with the intended use and Drugs required for registration.
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