质量风险管理在药品生产管理中的运用

药品的质量安全不仅仅会给生产企业信誉带来一定的影响,同时也会给人们的身体健康带来很大的威胁,在一定程度上会给社会经济的稳定发展带来负面影响。一直以来,药品安全问题受到了广泛的关注,但是,还是不断出现了很多的质量安全事件,给人们的健康带来了很大的伤害。对药品质量安全进行严格的控制,在药品生产管理过程中应用质量风险管理工作,能够更好的促进药品企业发展。文章对质量风险管理的内容和目的进行了介绍,同时,对质量风险管理现状进行了分析,希望能够更好的明确药品质量风险管理的方向,保证人们的健康不受到影响。     

风险评估在药品质量管理中的应用

随着我国药品质量控制工作的不断深入,对市场上流通药品的潜在安全风险越来越受到人们的关注。为了减少药品不良反应事件的发生,我国2010年修订版GMP要求对药品质量管理采取风险管理。风险评估作为风险管理中的一部分,对其要求也是非常严格的。针对药品质量风险管理的阶段进行分析,探讨风险管理在药品质量管理中的应用。     

失效模式与影响分析法评价药品GMP认证缺陷改正效果的探讨

目的探索质量风险管理在药品GMP认证中的应用,使用风险管理工具,指导药品GMP认证技术审评工作。方法用风险管理工具失效模式与影响分析(FMEA)法,评价企业缺陷项目改正的效果。结果和讨论使用FMEA评价整改报告,使药品GMP认证技术审查更系统化、更具科学性。     

失效模式与影响分析法评价药品GMP认证缺陷改正效果的探讨

目的探索质量风险管理在药品GMP认证中的应用，使用风险管理工具，指导药品GMP认证技术审评工作。方法用风险管理工具失效模式与影响分析（FMEA）法，评价企业缺陷项目改正的效果。结果和讨论使用FMEA评价整改报告，使药品GMP认证技术审查更系统化、更具科学性。     

论质量风险管理在药品生产企业中的作用

药品的质量是否达标不仅关系到企业的经营声望,更关系到使用者的自身安全,因此,药品质量的问题一直以来都备受社会关注。质量风险管理包括对药品评估、控制和审核等一系列过程,在药品生产企业经营中,质量风险管理是其十分重视的一项环节。各企业通过对药品生产质量的严格把控,在保证使用者健康、企业稳定发展的同时,也对国家社会经济发展产生正向作用。本研究对质量风险管理的相关定义和内容进行了简要阐述,并针对其在药品生产企业中所发挥的作用展开了深入分析。     

浅谈药品生产GMP管理过程中质量风险管理的实施与应用

文章阐述了现行法规对质量风险管理的要求,描述如何有效实施风险管理,并描述风险管理在药品生产及监管过程中的要求,为制药企业在GMP管理过程中如何实施质量风险管理提供方向。     

好贷网与费埃哲战略合作,提供大数据云风控服务

3月25日,全球领先的预测分析及决策管理软件公司费埃哲公司与中国领先的互联网金融服务平台好贷网正式宣布战略合作,基于FICO信贷评分决策云平台和好贷的大数据风控产品平台"好贷云风控",共同致力于利用云技术提供风险管理服务。费埃哲(FICO)中国区总裁陈建先生表示:"风险管理直接关系到资本和盈利,是所有信贷机构的核心竞争力,也是决定小微信贷机构生死存亡的生命线。费埃哲信贷     

药品流通环节质量风险管理

药品流通的环节主要分为采购、验收、存储和销售。药品流通过程中任意一个环节出现问题都有可能影响到消费者的用药安全。所以本研究对药品流通的各个环节面临的质量风险进行阐述,提出相应的风险管理方案。     

试论试剂质量对药品检验结果的影响分析

试剂质量对药品检测结果有着非常重大的影响,笔者在这里将根据我公司的药品检测情况对试剂质量对药品检测结果的影响进行相应的分析。公司需要对试剂含量以及溶出度等充分了解,这样才能够更好的分析出试剂质量对药品检测结果的影响。另外,在对药品进行检查的过程中需要重点检查试剂用途和试剂质量,严格控制试剂来源,并且加强对试剂的保存和管理。当然,在药品检查过程中一定要对异常现象进行重点分析,这样才能更好的保证药品的质量。另外,试剂检验人员也应该提高自我职业道德素养,将试剂药品检查工作落到实处,保证检验结果的准确性。     

乳制品检测实验室风险管理及控制研究

乳制品检测实验室必须要科学有效地进行风险管理, 利用风险管理体系, 将风险意识灌输到实验人员日常的工作中,构筑实验室风险管理的长效机制;加强对整个检测过程的层层把关, 加强对实验室运行过程中众多风险点的识别、分析、评估和防控, 将风险防控落实到位, 不断优化风险管理措施, 关注盲点, 发现细节, 弥补弱项, 规避和降低实验室的质量风险,切实提高风险管理的效能,推动实验室健康有序、高效平稳地运行,进而保证实验报告的可信度和准确度。     

Reliable identification of grapevine rootstock varieties using RAPD PCR on woody samples

Since grapevine ( Vitis spp .) rootstock material is being traded increasingly as disbudded woody material a lack of distinctive morphological features on such material necessitates an alternative and reliable means of identification. Methods described here were developed for rapid and efficient extraction of DNA from woody samples rich in phenolic compounds and polysaccharides, and for subsequent identification of varieties by RAPD PCR. Using these methods, and with the application of only one selected RAPD primer, we were able to differentiate sixteen rootstock varieties, including the seven varieties most commonly used in Germany. Problems commonly encountered with reproducibility of RAPD patterns were avoided by choosing primers with a dinucleotide sequence and a high G/C content that allowed a rather high annealing temperature of 45°C. Methods described here should also be useful for other horticultural crops, especially those with woody tissues rich in phenolic compounds and polysaccharides.     

An internet compendium of analytical methods and spectroscopic information for monomers and additives used in food packaging plastics

An internet website (http://cpf.jrc.it/smt/) has been produced as a means of dissemination of methods of analysis and supporting spectroscopic information on monomers and additives used for food contact materials (principally packaging). The site which is aimed primarily at assisting food control laboratories in the European Union contains analytical information on monomers, starting substances and additives used in the manufacture of plastics materials. A searchable index is provided giving PM and CAS numbers for each of 255 substances. For each substance a data sheet gives regulatory information, chemical structures, physico-chemical information and background information on the use of the substance in particular plastics, and the food packaging applications. For monomers and starting substances (155 compounds) the infra-red and mass spectra are provided, and for additives (100 compounds); additionally proton NMR are available for about 50% of the entries. Where analytical methods have been developed for determining these substances as residual amounts in plastics or as trace amounts in food simulants these methods are also on the website. All information is provided in portable document file (PDF) format which means that high quality copies can be readily printed, using freely available Adobe Acrobat Reader software. The website will in future be maintained and up-dated by the European Commission's Joint Research Centre (JRC) as new substances are authorized for use by the European Commission (DG-ENTR formerly DGIII). Where analytical laboratories (food control or other) require reference substances these can be obtained free-ofcharge from a reference collection housed at the JRC and maintained in conjunction with this website compendium.     

Aroma characterization of various apricot varieties using headspace–solid phase microextraction combined with gas chromatography–mass spectrometry and gas chromatography–olfactometry

The characterization of the aromatic profile of several apricot cultivars with molecular tracers in order to obtain objective data concerning the aromatic quality of this fruit was undertaken using headspace–solid phase microextraction (HS–SPME). Six apricot cultivars were selected according to their organoleptic characteristics: Iranien, Orangered, Goldrich, Hargrand, Rouge du Roussillon and A4025. The aromatic intensity of these varieties measured by HS–SPME–Olfactometry were defined and classified according to the presence and the intensity of grassy, fruity and apricot like notes. In the six varieties, 23 common volatile compounds were identified by HS–SPME–GC–MS. Finally, 10 compounds, ethyl acetate, hexyl acetate, limonene, β-cyclocitral, γ-decalactone, 6-methyl-5-hepten-2-one, linalool, β-ionone, menthone and (E)-hexen-2-al were recognized by HS–SPME–GC–O as responsible of the aromatic notes involved in apricot aroma and considered as molecular tracers of apricot aromatic quality which could be utilized to discriminate apricot varieties.     

Tests of potential functional barriers for laminated multilayer food packages. Part I: Low molecular weight permeants

The advent of the functional barrier concept in food packaging has brought with it a requirement for fast tests of permeation through potential barrier materials. In such tests it would be convenient for both foodstuffs and materials below the functional barrier (sub-barrier materials) to be represented by standard simulants. By means of inverse gas chromatography, liquid paraffin spiked with appropriate permeants was considered as a potential simulant of sub-barrier materials based on polypropylene (PP) or similar polyolefins. Experiments were performed to characterize the kinetics of the permeation of low molecular weight model permeants (octene, toluene and isopropanol) from liquid paraffin, through a surrogate potential functional barrier (25 μm-thick oriented PP) into the food simulants olive oil and 3% (w/v) acetic acid. These permeation results were interpreted in terms of three permeation kinetic models regarding the solubility of a particular model permeant in the post-barrier medium (i.e. the food simulant). The results obtained justify the development and evaluation of liquid sub-barrier simulants that would allow flexible yet rigorous testing of new laminated multilayer packaging materials.     

Analysis of benzo[a]pyrene in spiked fatty foods by second derivative synchronous spectrofluorimetry after microwave-assisted treatment of samples

A simple, rapid and inexpensive method has been developed for the determination of benzo[a     

The development of reference materials for paralytic shellfish poisoning toxins in lyophilized mussel. II: Certification study

This paper describes the second part of a project undertaken to develop certified mussel reference materials for paralytic shellfish poisoning toxins. In the first part two interlaboratory studies were undertaken to investigate the performance of the analytical methodology for several PSP toxins, in particular saxitoxin and decarbamoyl-saxitoxin in lyophilized mussels, and to set criteria for the acceptance of results to be applied during the certification exercise. Fifteen laboratories participated in this certification study and were asked to measure saxitoxin and decarbamoyl-saxitoxin in rehydrated lyophilized mussel material and in a saxitoxin-enriched mussel material. The participants were allowed to use a method of their choice but with an extraction procedure to be strictly followed. The study included extra experiments to verify the detection limits for both saxitoxin and decarbamoyl-saxitoxin. Most participants (13 of 15) were able to meet all the criteria set for the certification study. Results for saxitoxin.2HCl yielded a certified mass fraction of <0.07 mg/kg in the rehydrated lyophilized mussels. Results obtained for decarbamoyl-saxitoxin.2HCl yielded a certified mass fraction of 1.59+/-0.20 mg/kg. The results for saxitoxin.2HCl in enriched blank mussel yielded a certified mass fraction of 0.48 +/- 0.06 mg/kg. These certified reference materials for paralytic shellfish poisoning toxins in lyophilized mussel material are the first available for laboratories to test their method for accuracy and performance.     

Announcing a new international peer-reviewed journal:Food Science and Human Wellness now accepting manuscript submission in English

<正>We are pleased to announce the launch of a new international peer-reviewed journal-Food Science and Human Wellness,ISSN 2213-4530,which is an open access journal,produced and hosted by Elsevier B.V.on behalf of Beijing Academy of Food Sciences.Food Science and Human Wellness is an international peer-reviewed English journal that provides a forum for the dissemination of the     

Chinese CTP Market

According to Printing and Printing Equipment Industries Association of China（PEIAC）＇s statistics to the plate manufucturer in China, in 2013, the actual offset plate production has reached 346 million square meters in China. Among them, the CTP production volume was 245 million square meters, up by 11% than that of last year; the total sales of the CTP plate was 239 million square meters, up by 13%.     

Preparatory Work of Print China 2015 is Going Smoothly

正Held at Guangdong Modern International Exhibition Center,Print China 2015 will cover 7exhibition halls,besides the original Hall No.3,4,5,6,7,the newly built F zone of Hall 3 will be used too.The total area will be140,000 square meters.Hall 3:Offset and large printing equipment,package printing equipment,post press