某企业软胶囊制剂gmp实施与发展.研究

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1、山东大学硕士学位论文facilities，equipmentmanagement，materialsmanagement，theentireprocessofproductionmanagement,personnelmanagement，，andotheraspectsoftheimplementationofGMPconductedresearch．ThesoftwareontheEnterprisesystemsanddocumentproductionprocesscombininghighlightthecharact

2、eristicsofthesoftgelatincapsules．Inconclusion，qualityofproductsimproved，andvariousspeciesofsuperiorgraderatealsoincreasedwith100％rateproductqualification．However,thereareproblemsduringtheperiodofGMPperformance．AftertheGMPcertification，notenoughattentiontoenterprise，G

3、MPtrainingofworkersnotinplace；theredevelopmentofindustrialtransformationplantinvestedtoomuch，resultinginlowcapacityutilizationandexcessproductioncapacity,alackofnewproductdevelopmentpotential；thecountry'sday--to·-daysupervisionandmonitoringinadequatefollow—upinspecti

4、on，andSOon．WetrytofindtheshortcomingscomparedwiththeUnitedStatesandtoseekthecauses，sumupexperienceandrecommendations，putforwardrectificationandreformplan．Thedevelopmentofsoftcapsulesproductionon—linemonitoring；jointmarketingresources；theexpansionofexportprocessingdru

5、gscommissioned；expandinformationchannelsere．Lookingtothefuture，withaviewtoguidingsignificanceinimplicationimprovementofGMPinsoftcapsuleSproduct．GMPisacomplicatedsystematicprojectandanormativebehaviorforalongtimetoimplement．AtthesametimeGMPisthedynamicdevelopment．Asth

6、enewproducts，newmaterials，newprocessdevelopment，GMPisalsodevelopingitsowncontent．ItisonlythebeginningofthedevelopmentforenterprisesafterGMPcertification．Theenterprisesshouldhaveacorrectunderstandingtotheopportunitiesandchallengesfacing．Itisnecessarytotakethisissueser

7、iouslyandactivelyexplorethedevelopmentroads，strengthenself-disciplineandstrictimplementationofGMP．Keywords：softcapsules，GMP,implementation，development9山东大学硕士学位论文英文缩写GMPPEGWHoFDASDACGMPSOPQAQC符号说明中文名称药品生产质量管理规范聚乙二醇世界卫生组织美国药品食品监督管理局国家药品监督管理局现行GMP标准操作规程质量保证质量控制lO原创性声明本人

8、郑重声明：所呈交的学位论文，是本人在导师的指导下，独立进行研究所取得的成果。除文中已经注明引用的内容外，本论文不包含任何其他个人或集体已经发表或撰写过的科研成果。对本文的研究作出重要贡献的个人和集体，均已在文中以明确方式标明。本声明的法律责任由本人承担。论文作者