浅谈制药企业设备GMP管理

GMP设备管理是制药企业GMP管理的重要内容,本文从制药企业设备的设计选用,GMP验证方案的实施及GMP验证后的管理角度阐述了笔者对它的认识。     

基于GMP认证要求的制药企业ERP建设

随着我国加入WTO以及制药企业GMP认证的全面实施，建设基于GMP认证要求的制药企业ERP系统对企业的发展非常必要。该文对GMP认证的意义，ERP建设对GMP认证的作用以及根据GMP认证的特点，如何实现符合GMP认证要求的制药企业ERP建设方案的实施特点和构想作了较全面的论述。     

制药企业的GMP认证实施及其意义

随着社会的发展和科技的不断进步,制药企业需要进行GMP认证用来规范药品的生产活动.该认证有利于制药企业的长远发展,是企业发展的保障.该文从制药企业认证GMP的意义,企业认证准备以及实施过程三个方面进行分析,对如何有效的实施提出合理化的建议,推动企业认证化进程和制药企业的长远发展.     

GMP实施中的设备技术管理

从GMP规范对制药设备的要求出发,介绍了设备的购置、使用、检修、更新改造、验证等,为制药企业设备技术管理提供了参考.     

药品GMP与ISO9000质量管理标准

通过对药品GMP与国际标准化组织制定的ISO9000标准比较。使制药企业在实施GMP过程中自愿地引入ISO9000的思想和办法。在保证达到GMP要求的基础上,进一步吸收ISO9000有关内容形成一个更完整的质量管理体系。     

立足制药人才培养 创建特色GMP制药实训中心

GMP制药实训中心的建设对制药工程专业创新人才培养、专业发展和制药行业服务具有重要意义。针对制药工程特色专业实践教学的现状,阐述了创建具有专业特色GMP制药实训中心的必要性和重要意义,通过到企业和其他高校充分调研、积极开辟校政企合作渠道、规范实训中心的运行机制及管理制度等方式,探讨了如何创建特色GMP制药实训中心。结合广西民族师范学院实情,以特色专业发展为契机,创建特色鲜明的GMP制药实训中心,着力培养制药人才,服务当地医药行业。     

中小型制药企业如何完成GMP认证

通过《药品生产质量管理规范》认证，是国家对制药企业必须施行的法规性要求，为在国家规定期限内完成GMP技术改造和软件建设，并顺利通过GMP认证，企业必须有一支精干的技术管理队伍，有对GMP较深刻理解的领导者，有一个清晰的工作思路，有一套行之有效的运行方法，就可以以较短时间、较少投入实现通过GMP认证的目标。     

浅议ISO9000系列与GMP的关系

本文通过相同点与不同点的比较,阐述了ISO9000与药品GMP的关系,提出建议：只有科学地将二者结合,形成一个更完整的质量管理体系,才能提升制药企业的质量管理水平及竞争力。     

关于制药设备GMP功能的分析

制药设备是制药过程中必备的生产设备,而制药设备GMP功能则是在药品生产过程中的一种控制管理功能。而本文将从四个方面对制药设备GMP进行简单的介绍,即:净化、清洗、在线监测与控制和安全保护,系统的对相关结构进行设计分析,这对于规范我国的制药设备GMP至关重要。     

制药GMP质量体系有效性评价的模糊综合评价方法

提出药品生产质量管理规范（简称GMP）质量体系有效性评价的模糊综合评价方法,并运用该方法对1个制药公司的GMP质量体系的有效性进行实际测评分析。模糊综合评价方法运用模糊数学理论,从质量方针和目标、产品质量的稳定性、质量改进与创新、资源管理4个方面来综合评价制药GMP质量体系运行的有效性,评价结果具有整体性。     

我国兽药生产质量管理规范发展概况

通过对国际上GMP和我国GMP的发展情况进行研究,特别是对我国兽药GMP的发展情况和不同版本兽药GMP之间的差异进行了研究,目的在于探讨其内在的发展规律.结果表明,由于受国际以及我国人药GMP发展的影响,我国兽药GMP正在向科学、合理、适用的方向发展.     

GMP在RIL群体中的分离及与SIG、AWRC和WPC的相关分析

谷蛋白大聚合体(GMP)是谷蛋白聚合体的重要组成部分,其含量反映了谷蛋白聚合体粒度分布状况。本文以一个普通小麦的重组自交系后代群体为试验材料,对GMP的提取、分离和测定方法以及GMP含量、碱性水保持力(AWRC)、膨胀系数(SIG)及湿面筋含量的群体变异、GMP含量与其它三项品质指标的相关性进行了研究。结果表明：该GMP含量的提取、分离和测定的方法具有简单、快速、稳定、经济的特点,实验结果相对准确,可信度高,重复性好。GMP含量、AWRC、SIG及湿面筋含量在群体后代中表现为微效多基因控制的数量性状,相对亲本的性状,变异较大。GMP含量与SIG、湿面筋含量呈极显著相关(r=0．63,r=0．56),而与AWRC没有明显的线性相关。     

基于代建制模式的GMP机制设计探讨

介绍美国工程项目管理中CM@R模式GMP（guaranteed maximum price）控制投资的过程。用委托代理理论解析GMP投资控制设计机制、比较CM@R与代建制投资控制设计机制差异,提出代建制模式下应用GMP控制投资的机制设计建议,可分为三个阶段应用实施：两阶段招标法;联合投标选择代建单位;代建单位总包。     

Cyclic GMP can increase rod outer-segment light-sensitive current 10-fold without delay of excitation

To test the hypothesis that cyclic GMP is the internal messenger coupling rhodopsin activation to membrane excitation in vertebrate rod photoreceptors, we used a novel technique combining measurement of membrane currents of isolated salamander rods with a suction electrode and the introduction of cyclic GMP through a whole-cell recording patch pipette. Rupture of an attached patch was followed by a rapid (approximately 10 s), approximately 10-fold increase in outer-segment membrane current, all of which was light-sensitive. There was little change in the rising phase of the response to a saturating flash, but the duration of the saturated phase of the response increased approximately 10-fold. The effects reversed completely within 3-4 min after withdrawal of the cyclic GMP-containing patch pipette. A formal kinetic analysis shows that the first two observations are inconsistent with the postulate that cyclic GMP opens the light-sensitive conductance by simple binding to channels, unless free cyclic GMP in the outer segment is assumed to be much lower than published estimates, and most of the outer-segment cyclic GMP is bound and inexchangeable on the timescale of 200 ms. Furthermore, our results suggest that rod cyclic GMP is not involved solely in keeping the light-sensitive conductance open, but may also affect the activity of the phosphodiesterase that mediates cyclic GMP hydrolysis.     

Prevention of natural motoneurone cell death by dibutyryl cyclic GMP

Natural neuronal cell death is a well-described developmental phenomenon common to many nerve centres in a variety of animal species. Neuronal survival has been shown to depend on the presence and size of the available target tissue and it has been suggested that neuronal survival is dependent on successful competition for either a limited number of synaptic sites or a limited amount of trophic factor(s). In the lateral motor column of the lumbar spinal cord in the chick embryo, the period of axon elongation and innervation of the periphery has been shown to precede that of natural motoneurone cell death. While muscle contractile activity appears to regulate the extent of motoneurone death, to date the intracellular molecular events that initiate and regulate the developmental process of natural neuronal cell death or, more importantly, neuronal survival are unknown. Our earlier studies suggested that either contact or association between spinal cord processes and muscle cells during neuromuscular junction formation in vivo leads to an increase in cyclic GMP in whole spinal cord. We now show that treatment of chick embryos with the membrane-permeable cyclic GMP analogue, dibutyryl cyclic GMP during the period of natural motoneurone cell death prevents greater than 58% of natural motoneurone cell death in the lumbar lateral motor column.     

Induction by cyclic GMP of cationic conductance in plasma membrane of retinal rod outer segment

Vertebrate rod photoreceptors hyperpolarize when illuminated, due to the closing of cation-selective channels in the plasma membrane. The mechanism controlling the opening and closing of these channels is still unclear, however. Both 3',5'-cyclic GMP and Ca2+ ions have been proposed as intracellular messengers for coupling the light activation of the photopigment rhodopsin to channel activity and thus modulating light-sensitive conductance. We have now studied the effects of possible conductance modulators on excised 'inside-out' patches from the plasma membrane of the rod outer segment (ROS), and have found that cyclic GMP acting from the inner side of the membrane markedly increases the cationic conductance of such patches (EC50 30 microM cyclic GMP) in a reversible manner, while Ca2+ is ineffective. The cyclic GMP-induced conductance increase occurs in the absence of nucleoside triphosphates and, hence, is not mediated by protein phosphorylation, but seems rather to result from a direct action of cyclic GMP on the membrane. The effect of cyclic GMP is highly specific; cyclic AMP and 2',3'-cyclic GMP are completely ineffective when applied in millimolar concentrations. We were unable to recognize discrete current steps that might represent single-channel openings and closings modulated by cyclic GMP. Analysis of membrane current noise shows the elementary event to be 3 fA with 110 mM Na+ on both sides of the membrane at a membrane potential of -30 mV. If the initial event is assumed to be the closure of a single cyclic GMP-sensitive channel, this value corresponds to a single-channel conductance of 100 fS. It seems probable that the cyclic GMP-sensitive conductance is responsible for the generation of the rod photoresponse in vivo.     

香菇菌深层发酵生产鸟苷酸试验

报道了香菇菌深层发酵生产鸟苷酸试验结果。以香菇菌Ｃｒ－０２１为材料，经多组试验结果分析。得出鸟苷酸产量与菌丝全干重成正比关系。应用Ｌｇ（３＾４）正交试验，得出培养基配方，在此基础上，设计了Ａ，Ｂ，Ｃ等３种培养基，并进行了发酵分析，其中Ｂ产鸟苷酸含量为２．１ｇ／Ｌ，氨基氮０．２ｇ／Ｌ。