In recent years, the quality management model of pharmaceutical excipients is constantly being transformed. With the advent of the "strict" era of drug safety supervision, strengthening the quality control of pharmaceutical excipients is not only a matter of pharmaceutical excipients production enterprises, but also an important responsibility of pharmaceutical manufacturers.
Due to the late start and development of pharmaceutical excipients in China, the quality level is uneven. Although the "Drug Administration Law" promulgated in 2001 and the "Quality Management Regulations for the Production of Pharmaceutical Excipients" issued in 2006 put forward relevant requirements for the management of pharmaceutical excipients, they are only guiding principles.
Whether it is based on the guidance of national policies or the need for industrial upgrading and development, the industry's implementation guidelines for the quality management of pharmaceutical excipients are increasingly loud. Some insiders believe that the improvement of quality management will still take some time. Pharmaceutical companies and pharmaceutical auxiliary enterprises can improve product quality control through agreed standards, which is expected to become one of the important development trends of the future industry.
In fact, in the first half of 2013, the state also promulgated the "Regulations on Strengthening the Supervision and Management of Pharmaceutical Excipients" (hereinafter referred to as the "Regulations"), requiring local drug regulatory authorities at all levels to strengthen the supervision of the production of pharmaceutical excipients. Carry out daily supervision of pharmaceutical excipients in the administrative region, or carry out extended inspections on pharmaceutical excipients in accordance with the problems found in the supervision and inspection of pharmaceutical preparation enterprises.
The "Regulations" also proposes to focus on checking whether the production of pharmaceutical excipients meets the "Quality Management Standards for the Production of Pharmaceutical Excipients", whether to strictly control the quality of raw materials, whether to carry out production according to the approved or filed process, whether to establish a perfect batch number management system and the factory Inspection system. For those who do not accept the inspection, pharmaceutical preparation enterprises shall not use the pharmaceutical excipients they produce.
It can be seen that the state attaches great importance to the quality supervision of pharmaceutical excipients. It is understood that with reference to the 2010 version of the drug GMP implementation guide and the GMP implementation guide for traditional Chinese medicine decoction pieces, the association is currently collecting opinions in the pharmaceutical excipients industry and the preparation industry, hoping to come up with relevant drafts this year. From easy to difficult, gradually advance.
At present, some pharmaceutical auxiliary production enterprises in China have improved the production standards of pharmaceutical supplements according to the needs of the preparation enterprises, especially the functional requirements, when producing pharmaceutical excipients with national standards. But what we need to do is to generally improve the quality of pharmaceutical excipients.
Transferred from China Industrial Economic Information Network
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