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乙型脑炎减毒活疫苗批签发管理与质量评价 总被引:1,自引:1,他引:0
目的比较乙型脑炎减毒活疫苗实施批签发前后的质量变化,评价疫苗的质量控制。方法通过对市场抽检疫苗样品和批签发送检的疫苗样品质控关键项目测定结果及制造和检定记录摘要审核,对疫苗的质量和改进趋势进行分析、归纳和总结。结果3个企业生产的乙脑活疫苗在1990~2004年期间,尤其是生产初期,疫苗病毒滴度≥5.7lgpfu.mL-1的批次合格率为58.6%~100%;疫苗热稳定性试验合格批次占15%~100%;其中A企业2001~2004年,疫苗热稳试验100%合格。从2005年实施批签发后,3个企业生产的乙脑活疫苗病毒滴度均为100%合格。2006和2008年国家市场监督抽验的疫苗病毒滴度结果合格率达97.4%。结论乙脑活疫苗实施批签发后的病毒滴度合格率达100%,较实施前有明显提高。国家市场监督抽验的疫苗测定结果显示,乙脑活疫苗的质量稳定,病毒滴度合格率为97.4%。通过疫苗批签发可以准确、具体的了解企业生产和质量管理情况,督促企业规范生产、完善工艺、加强质量管理。 相似文献
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目的:以ISO/IEC 17025的要求为基础,结合实验室检测(LT)板块指标条款的要求,针对新批签发机构构建网络实验室,以满足世界卫生组织(WHO)疫苗国家监管体系(NRA)评估要求,保证新冠疫苗批签发网络实验室技术和质量管理的一致性,确保批签发质量。方法:依据《中华人民共和国药品管理法》《中华人民共和国疫苗管理法》《中华人民共和国药品管理法实施条例》《生物制品批签发管理办法》,参考ISO/IEC 17025:2017、药品质量控制实验室良好操作规范(GPCL)、WHO全球基准评估工具(GBT)的要求,结合批签发实际工作中的解决方案,从组织构架、人员、环境设施、设备、溯源、实验方法、样品、文件和记录、检验能力的质量保证及风险控制、报告、数据控制和信息管理、批签发检验策略和检验频率的制修订和执行、超出质量标准的处理、绩效考核、免疫监测15个方面建立批签发网络实验室质量体系专家共识。结果与结论:我国批签发网络实验室可以以ISO/IEC 17025: 2017为核心,适当纳入WHO全球基准评估工具实验室板块要求(LT),建立批签发网络实验室质量管理体系,保证批签发网络实验室质量管理体系的一致性,实现满足WHO-NRA评估、新冠疫苗批签发及批签发网络实验室建设需求。 相似文献
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欧盟与中国生物制品批签发管理的比较和考虑要点 总被引:1,自引:0,他引:1
介绍了欧盟生物制品批签发的实施及管理情况,并与我国生物制品批签发工作进行比较.对今后批签发工作提出了几点考虑意见和建议,主要包括:加强企业管理,不断完善批签发管理程序,加强信息化和实验室质量保障体系建设,以及加强批签发实施单位与生产企业的交流与合作. 相似文献
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"批签发"是英文Lot release的意译,是世界卫生组织(WHO)提出的疫苗管理6项基本职能(The Six Critical Control Functions)中的1项.其含义是:批签发的产品上市销售前每一批号都须经国家当局对其质量的全面认可. 相似文献
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Dayan GH Iskander J Glasser J English-Bullard R Fullerton KE Chen R 《Pharmacoepidemiology and drug safety》2005,14(10):671-676
PURPOSE: There is currently no systematically available information available on how rapidly a specific lot of vaccine is used once distributed. We used data from reports to the Vaccine Adverse Event Reporting System (VAERS) to develop a proxy means of surveillance for the lifecycle of selected vaccine lots. METHODS: A convenience sample, consisting of selected lots of: diphtheria, tetanus, and acellular pertussis (DTaP), Haemophilus influenzae type b (Hib), Hepatitis B, and varicella vaccines, was selected for lifecycle analysis. Assuming that circulation of a vaccine lot is proportional to vaccine-specific adverse event (AE) reporting for that vaccine type, we constructed Gamma distributed usage models and compared them with lot-specific VAERS reports to estimate the actual lifecycle of lots in the system. RESULTS: Evidence of lot circulation was detected within 1-2 months, and a peak was observed 3-4 months after the vaccine release date for most of the study vaccines. Ninety percent of the vaccine doses in each lot were estimated to be used within 5-9 months of distribution. The length of time a vaccine lot was in use ranged from 5 to 17 months from earliest vaccination date. CONCLUSIONS: Our modeled and inferred administration of the selected lots of different vaccines were concordant. This method may be useful for spatial and temporal tracking of vaccine lot utilization. 相似文献
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This brief commentary reviews endotoxin levels of commercial vaccines and puts them into context for the preclinical researcher working in vaccines. Vaccines are not required to adhere to endotoxin levels as outlined in the United States Pharmacopoeia. Vaccine manufacturers have to show that the vaccine is safe and efficacious in clinical trials. Endotoxin limits are typically lot release specifications for most vaccines, but these values are not available to most researchers designing preclinical experiments. The limits outlined are calculated from endotoxin levels found in a variety of vaccine types such as gene vectors, recombinant subunits, polysaccharide, live attenuated, inactivated and toxoid vaccines. It is clear that certain families of vaccines such as toxoids contain much higher levels of endotoxin, where others such as purified recombinant subunits and gene vectors may contain very low levels. 相似文献
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The development and evaluation of outer membrane vesicles as vaccines against meningococcal disease has been carried out for more than two decades. Although such vaccines have limitations and are not widely licensed, they continue to be used to disrupt clonal outbreaks caused by group B meningococci and a wealth of information is now available from large-scale clinical studies. One dimensional polyacrylamide gel electrophoresis and semi-quantitative measurement of the major proteins is one method used to evaluate and control these products. However, it is often difficult to determine exactly which bands on a one dimensional gel correspond to the key antigens whose presence must be demonstrated for control and lot release. We have therefore carried out mass spectrometric analyses of outer membrane vesicle vaccine samples to definitively identify the bands containing seven key antigens: Omp85, FetA, PorA, PorB, RmpM, OpcA and NspA. An additional 33 proteins present in the vaccine were also identified and this information will be useful both for future quality control and for the interpretation of data from vaccine trials. 相似文献
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J H Peetermans 《Journal of pharmaceutical and biomedical analysis》1989,7(2):227-232
Vaccines manufactured following "classical" methods contain inactivated or infectious but attenuated viruses or bacteria. In some instances, the inactivated agents are purified. In other cases, the vaccines contain protein subunits or practically pure polysaccharides. It is generally accepted that the final product cannot be completely characterised and that therefore extensive "in-process" controls are necessary to prove the consistent quality of such vaccines. Control tests are carried out on the substrate, the pooled bulk vaccine and on the final containers. Vaccines produced by recombinant DNA techniques consist of pure proteins. The production is carried out by the multiplication of the "working seed" under well-defined standardised conditions followed by clarification, extraction, purification, formulation. "In-process" controls are incorporated at each step and specifications for acceptance are formulated. The biological methods used for the classical vaccines are completed by physicochemical and immunological determinations of antigen content, identity and purity for the "new generation" products. The requirements for the manufacturers are based on the documents issued by the World Health Organisation and by the national control authorities. The marketing of vaccines is based on a lot by lot release procedure, whereby each lot is tested by the manufacturer and the national control authority before use. Hepatitis-B vaccine, derived from transformed yeast cells, is the first and sole vaccine which has obtained a world-wide license. The quality assessment of this vaccine has been achieved following the requirements for the new generation of biomolecules. It is an example for future vaccines. 相似文献
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目的:考察目前市售国内外人血白蛋白制品中不溶性微粒的含量情况并与自检结果进行对比。方法:随机抽取来自国内外企业的规格为200 g.L-1,每瓶50 mL的人血白蛋白共53批,以GWF-8JA型微粒检测仪按2010年版中国药典三部附录第一法光阻法对抽检样品进行不溶性微粒质量考察。每批供试品取1瓶,分别检测供试品中≥10μm和≥25μm 2个通道的微粒总数,将所得结果与自检数据进行趋势比对,并将2个粒径通道所测得的结果按微粒数的多少分成A、B、C、D、E 5个级别并计算符合各个级别的人血白蛋白的批次数。结果:53批人血白蛋白全部符合2010年版中国药典三部的相关规定,抽验的人血白蛋白样品中有80%以上的制品的不溶性微粒结果能够达到A级水平,各批次的检验结果与企业自检结果具有一致性。结论:随机抽样结果表明80%以上的人血白蛋白不溶性微粒结果远低于国家相关标准规定,制品质量控制良好,实验室间结果趋势一致。 相似文献
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目的 对我国2014—2016年A群C群脑膜炎球菌多糖疫苗有效组分进行质量趋势分析研究。方法 收集2014—2016年国内两家企业的送检A群C群脑膜炎球菌多糖疫苗批签发资料,对疫苗有效组分A群和C群多糖含量检测结果进行趋势分析,同时按规定随机抽取一定批次疫苗进行多糖含量测定,并与企业自检结果进行统计学比较分析。结果 2014—2016年所有送检疫苗批次的生产及检验记录摘要审查符合标准要求;趋势分析结果显示,各企业的A群和C群多糖含量测定结果均在警戒限(平均值±2SD)以内,环比年度统计学比较分析也未发现显著性差异,趋势平稳,一致性较好;中国食品药品检定研究院对不同批次疫苗多糖含量检测结果与企业自检结果无显著性差异。结论 我国的A群C群脑膜炎球菌多糖疫苗产品中多糖含量稳定,批间一致性较好,检验方法可靠,从而确保了上市产品的质量。 相似文献