The U.
S.
Food and Drug Administration (FDA) is the world's most stringent regulatory authority for the inspection and supervision of pharmaceutical products, and its recognition is equivalent to obtaining a "world pass"
for the pharmaceutical industry.
Many companies have also made efforts
to pass the on-site inspection of the US FDA.
Since the beginning of this year, Beijing Yiling Bio has successfully passed the FDA on-site certification inspection, and Jiangsu Wanbang, a subsidiary of Fosun Pharma, has also passed the on-site inspection
of the US FDA.
The author has learned that recently another company, Aomei Pharmaceutical (Hainan) Co.
, Ltd.
, received a formal letter notice and on-site inspection report (EIR) from the US Food and Drug Administration (hereinafter referred to as the FDA) confirming that its quality management system complies with the requirements of
the FDA cGMP.
This inspection is the first time that Aomei Pharmaceutical has been inspected by the FDA, and the inspectors have carried out a comprehensive on-site inspection of the oral solid preparation production line, covering the quality assurance system, production system, plant facilities and equipment system, material system, packaging and labeling system, laboratory system and other related content, and finally the project successfully passed the on-site verification
.
According to the data, Aomei Pharmaceutical (Hainan) Co.
, Ltd.
is a Hong Kong-owned pharmaceutical enterprise
integrating scientific research, development, production and sales.
To "market-oriented, quality of survival, innovation as the driving force, management and development" is the company's consistent philosophy, "the development of natural medicines, promote human health" is the fundamental goal
of the company's development.
The company's investor, Hong Kong Kong and Macao American Pharmaceutical Factory Co.
, Ltd.
, has a strong ability in
new drug development, research and market development.
It is reported that in order to implement the long-term planning and development of Aomei Pharmaceutical (Hainan) Company, the company has invested a lot of money to implement new technology transformation and talent introduction, training, so far the factory not only has advanced and perfect GMP certified plant and various types of advanced production and quality testing equipment, such as key equipment efficient non-porous coating machine, microwave drying sterilization machine, automatic drum type round pill shaping unit, high performance liquid chromatography, gas chromatography, etc.
, the company also according to GMP The specification requires the introduction and training of a large number of new generation of cadres and employees
who have mastered the level of modern pharmaceutical technology and management.
In the process of development, Aomei Pharmaceutical (Hainan) Co.
, Ltd.
has always adhered to the principle of "quality first", implemented standardization, proceduralization and standardized management in strict accordance with GMP specifications, and established a sound quality assurance system, so that every link from raw materials into the factory to the finished product has been effectively monitored
.
According to the data, Aomei Pharmaceutical became the 7th drug manufacturer in Hainan Province to pass FDA certification, which also marks that Hainan Province has made new progress in the internationalization of pharmaceutical enterprises and achieved new results in its strategy of
going global.
It is understood that in recent years, the Hainan Provincial Food and Drug Administration has successively issued a number of policies and measures to strengthen government and enterprise services, encourage research and development innovation, optimize licensing procedures, improve approval efficiency, help the innovation and transformation of the biomedical industry, encourage enterprises to cultivate internal strength, and achieve high-quality development
。 In order to help enterprises understand the international drug production quality standard system, since 2021, the provincial bureau has joined hands with Haikou National High-tech Zone and the Provincial Pharmaceutical Industry Association for two consecutive years to carry out special interpretation and practical training on international certification inspection laws and policies, encouraging enterprises to expand the market in many ways, take the road of internationalization, carry out international certification, and enhance the overall competitiveness
of Hainan's biomedical industry.
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