Be a new force to strengthen the supervision of pharmaceutical excipients

CFDA is the highest authoritative arbitration institution of food and drug inspection technology in China, and also the research institution of standard products such as drugs, medical devices, health food, cosmetics, etc., including pharmaceutical excipients In recent years, as the Testing Institute of packaging materials and pharmaceutical excipients, which is specifically responsible for the inspection and testing of pharmaceutical excipients, it has given full play to the technical support role of the supervision of pharmaceutical excipients, focused on strengthening the construction of inspection and testing capacity, and made positive contributions to promoting the continuous improvement of the quality and safety level of pharmaceutical excipients What effective work has been done by the Institute of packaging materials and pharmaceutical excipients inspection, standard drafting and scientific research? What are the future development goals and tasks? Recently, our newspaper made an exclusive interview with sun Huimin, the director of the Institute Sun Huimin, director of the Institute of packaging materials and pharmaceutical excipients of the Chinese Academy of inspection, said In recent years, CFDA has been continuously improving the inspection and testing capacity of pharmaceutical excipients, striving to build a brand of inspection and testing of pharmaceutical excipients, and becoming a new force to strengthen the supervision of pharmaceutical excipients "We attach great importance to the inspection and testing of pharmaceutical excipients, and have strengthened and guaranteed them in all aspects, from institutional setting to staffing, from institutional construction to funding." According to sun Huimin, in the face of the new situation and new tasks in the development of drug inspection and testing, in October 2002, the former China Institute for the control of pharmaceutical and biological products, after in-depth investigation and careful preparation, formally requested the former State Drug Administration to establish a testing room for pharmaceutical excipients and packaging materials In March 2003, the former State Administration replied to the establishment and approved the responsibilities of the office The task is to undertake the inspection and laboratory review of drug packaging materials and pharmaceutical excipients, and to coordinate the relevant work of provincial drug packaging materials and pharmaceutical excipients inspection institutions According to the approval document, the original China Inspection Institute applied to the original National Bureau and was approved with a total of 11 million yuan for the construction project of drug packaging materials laboratory Based on this fund, it raised funds from various sources and opened a wide range of channels According to the actual needs and inspection requirements of the laboratory, it purchased nearly 100 sets of international advanced testing equipment for pharmaceutical auxiliary materials and packaging materials, and officially established the laboratory for pharmaceutical auxiliary materials and packaging materials 。 After nearly 8 years of development, in November 2011, on the basis of the Department, the Inspection Institute for packaging materials and pharmaceutical auxiliary materials was established The functions of the Institute are as follows: to undertake the registration inspection, supervision inspection, entrusted inspection, import inspection, re inspection and technical verification of the relevant packaging materials and pharmaceutical auxiliary materials such as drug packaging materials; to undertake the technical review and verification of the preparation and revision of the relevant national standards; to undertake the research and calibration of the reference materials of the relevant packaging materials and pharmaceutical auxiliary materials such as drug packaging materials; To undertake the research on the compatibility of drug packaging materials and pharmaceutical excipients with drugs; to undertake the technical review of registration of drug packaging materials and other matters Last year, the original state administration issued an urgent notice on the night of the incident, requesting the suspension of the sale and use of the capsules, and immediately ordered CFDA and relevant provincial administrations to carry out the inspection, supervision and inspection of related products CFDA immediately launched the emergency plan As the main emergency inspection business office for this chromium excess capsule incident, the packaging materials and auxiliary materials Institute responded quickly, participated in all the work, actively carried out relevant emergency inspection work, completed the emergency inspection task on time with quality and quantity guaranteed, provided timely and reliable inspection data support for the decision-making of the original National Bureau, and played a technical support Strong backing role Sun Huimin believes that it's the responsibility to provide accurate data that can stand the test of history and scientific test, and the emergency response ability can reflect the level of daily refined management to some extent In the past drug damage events caused by the quality problems of pharmaceutical excipients, such as plasticizer drug events, methotrexate injection events, acanthopanax senticosus price injection events and chromium over standard capsule events, the Institute has successfully completed various emergency inspection tasks and won the recognition of the former State Administration and the Chinese Academy of inspection for many times "The responsibility of drug inspection and testing is great Every data we issue is related to the health of the people and the life and death of the enterprise." Sun Huimin pointed out that as the technical support unit for the supervision of auxiliary materials and packaging materials of the State Administration, the Institute of packaging materials and auxiliary materials has paid attention to system construction since the beginning of its establishment, striving to bring all work into the scientific and standardized management track In daily work, the staff are required to strictly follow the standards, procedures and tests in accordance with the law in every experiment No matter what challenges and pressures they face, they should also keep professional calm, always guide each work with the scientific inspection spirit of "serving the people, seeking truth, preciseness and innovation", and use the quality policy of "science, independence, justice and authority" to ensure the inspection and test The data are accurate and reliable With the gradual standardization and development of various works, the Institute has gradually formed its own technical characteristics in the field of pharmaceutical excipient drug packaging material testing, especially in the aspects of quality control technology, compatibility research and test method innovation; at the same time, it has played an important role in the drafting of relevant standards and regulations Sun Huimin introduced that the Institute of packaging materials and accessories cooperated with the national pharmacopoeia commission and jointly with the provincial institutes to complete the drafting, review and writing of the 2010 and 2015 Chinese Pharmacopoeia standards for pharmaceutical auxiliary materials, initially established the national pharmaceutical auxiliary materials and drug packaging materials reference material guarantee system, and developed 51 kinds of pharmaceutical auxiliary materials reference materials As the domestic implementing agency of aerosol industry plan, the Institute has also carried out the step-by-step elimination of chlorofluorocarbons in the national pharmaceutical aerosol industry, and successively participated in the drafting, formulation and revision of the original National Bureau's regulations on pharmaceutical excipients, drug packaging materials and the guiding principles for technical evaluation of drug packaging materials.