生物制品GMP检查指南(双语版)

GMPINSPECTIONGUIDELINEFORBIO-PRODUCT1生物制品GMP检查指南GMPINSPECTIONGUIDELINEFORBIO-PRODUCT由国家食品药品监督管理局颁发ISSUEDBYSFDAOFCHINA1.机构与人员COMPANYORGANIZATIONANDPERSONNEL0402：生物制品生产企业生产和质量管理负责人是否具有相应的专业知识（细菌学、病毒学、生物学、分子生物学、生物化学、免疫学、医学、药学等），并具有丰富的实践经验以确保在其生产、质量管理中履行其职责。Whetherthepersonnelwhoareinchargeofthebio-productsproductionandqualitymanagementthathavethecorrespondingknowledgebackgroundonBacteriology,Virology,Biology,MolecularBiology,Biochemistry,Immunology,Medicine,Pharmaceuticsetc.andtopossessabundantexperiencetoinsurefulfillingtheresponsibilitiesintheproductionandqualitymanagement.0702：从事生物制品制造的全体人员（包括清洁人员、维修人员）是否根据其生产的制品和所从事的生产操作进行专业（卫生学、微生物学等）和安全防护培训。Whetherallthepersonnel(includingthecleaningstuffandmaintenancestuff)thatrelatedwiththebio-productsproductionwhohavereceivedtheprofessionaltrainingonproductionandcorrespondingknowledge(Hygiene,Microbiologyetc.)andsecuritytraining.2.厂房与设施PREMISEANDFACILITY＊2201：生产用菌毒种与非生产用菌毒种、生产用细胞与非生产用细胞、强毒与弱毒、死毒与活毒、脱毒前与脱毒后的制品和活疫苗与灭活疫苗、人血液制品、预防制品等加工或灌装是否同时在同一生产厂房内进行。Whethertheprocessorfillingprocedureabouttheproductionornon-productioncellbankorseedbank,strongorweakstrain,inactiveoractivestrain,beforeorafterdetoxicant,deadorlivingstrain,humanbloodproduct,preventiveproductetc.areproceedinginthesamefacilityatthesametime.＊2202：生产用菌毒种与非生产用菌毒种、生产用细胞与非生产用细胞、强毒与弱毒、死毒与活毒、脱毒前与脱毒后的制品和活疫苗与灭活疫苗、人血液制品、预防制品等贮存是否严格分开。Whetherthestorageabouttheproductionornon-productioncellbankorseedbank,strongorweakstrain,inactiveoractivestrain,beforeorafterdetoxicant,deadorlivingstrain,humanbloodproduct,defendantproductetc.arestrictlyseparated.＊2203：不同种类的活疫苗的处理、灌装是否彼此分开。Whethertheprocessandfillingforvariouslivingvaccinesareseparatedfromeachothers.GMPINSPECTIONGUIDELINEFORBIO-PRODUCT2＊2204：强毒微生物操作区是否与相邻区域保持相对负压，是否有独立的空气净化系统，排出的空气是否循环使用。Whetherthepressureintheoperationareaforthestrongstraintobekeptrelativelynegativecomparingtotheabutareas.Andisthereindependentairsystemandistheairre-circulated?＊2205：芽孢菌制品操作区是否与相邻区域保持相对负压，是否有独立的空气净化系统，排出的空气是否循环使用，芽孢菌制品的操作直至灭活过程完成之前是否使用专用设备。Whetherthepressureintheoperationareaforthesporebacteriapreparationtobekeptrelativelynegativecomparingtotheabutareas.Andisthereindependentairsystemandistheairre-circulated?Istherespecifiedequipmenttobeappliedalthoughthedurationofsporebacteriaproductpreparationuntiltheinactivationprocedure?＊2206：各类生物制品生产中涉及高危致病因子的操作，其空气净化系统等设施是否符合特殊要求。Whethertheairsystemforvariousbio-productsrelatedtohighriskpathogenicfactorswhichareincompliancewiththespecialrequirement.＊2207：生物制品生产过程中使用某些特定活生物体阶段的设备是否专用，是否在隔离或封闭系统内进行。Whethertheequipmenttobeusedinspecialphaseofproductionforsomelivingorganismsinthemanufactureofbio-productwhichisseparatedandbeenappliedintheisolatedenvironment.＊2208：卡介苗生产厂房和结核菌素生产厂房是否与其它制品生产厂房严格分开，卡介苗生产设备要专用。WhetherthepremisefortheBCGvaccineortuberculinproductionwhichisstrictlyseparatedwithotherspremise.AndtheequipmentforBCGvaccineproductionmustbespecified.＊2209：炭疽杆菌、肉毒梭状芽孢杆菌和破伤风梭状芽孢杆菌制品在相应专用设施内生产。Whethertheb.authraci,ClostridiumBotulinumandClostridiumtetanuspreparationthosearemanufacturedwithspecifiedequipment.＊2210：设备专用于生产孢子形成体，当加工处理一种制品时是否集中生产，某一设施或一套设施中分期轮换生产芽孢菌制品时，在规定时间内是否只生产一种制品。Theequipmentmustbespecifiedintheproductionofsporeformer.Istheproductioncentralizedwhenprocessingonepreparation?Whenmanufacturingdifferentvarietiesofsporeproductswithonesetofequipmentinturn,isthatonlyoneproducttobepreparedintheestablishedperiod.＊2211：生物制品生产的厂房与设施是否对原材料、中间体和成品存在潜在污染。Whetherthepremiseandfacilitywhichtobeappliedtomanufacturethebio-productsthatwillpollutetherawmaterial,intermediateproductandfinalproductpotentially.＊2212：聚合酶链反应试剂（PCR）的生产和检定是否在各自独立的建筑物中进行，防止扩增时形成的气溶胶造成交叉污染。WhethertheproductionandinspectionofPCRreagentstobeproceededintheisolatedGMPINSPECTIONGUIDELINEFORBIO-PRODUCT3areatopreventthecross-contaminationcausedbyaerosolintheamplificationprocedure.＊2213：生产人免疫缺陷病毒（HIV）等检测试剂，在使用阳性样品时，是否有符合相应规定的防护措施和设施。WhenmanufacturingtheHIVrelevanttestreagents,isthereanyequipmentorfacilityincompliancewiththeestablishedprovisionduringtheprocessofmanipulatingthepositivesample.＊2214：生产用种子批和细胞库，是否在规定储存条件下专库存放，是否只允许指定的人员进入。Whetheronlyauthorizedpersonnelarepermittedtoentertheareawherestoringtheseedlotandcellbankandwhetherallthesematerialsarestoredinthespecifiedwarehousepursuanttothespecifiedcondition.＊2215：以人血、人血浆或动物脏器、组织为原料生产的制品是否使用专用设备，是否与其他生物制品的生产严格分开。Istherespecifiedequipmenttobeappliedtotheproductionwhichbasedontherawmaterialofhumanblood,humanplasmaoranimaltissue?Isthiskindofproductiontobeisolatedstrictlywithothersbio-productpreparation?＊2216：使用密闭系统生物发酵罐生产生物制品可以在同一区域同时生产（如单克隆抗体和重组DNA制品）。Thebio-productmanufactureswhichmanipulatedwiththeair-lockedbioreactorthatcanbeprecededinthesameareaatsametime(e.g.monoclonalantibody&recombinantDNApreparation).＊2217：各种灭活疫苗（包括重组DNA产品）、类毒素及细胞提取物，在其灭活或消毒后可以与其他无菌制品交替使用同一灌装间和灌装、冻干设施。但在一种制品分装后，必须进行有效的清洁和消毒，清洁消毒效果是否定期验证。Allkindsofinactivevaccines(includingrecombinantDNAproducts),toxoidandcellextractwhichcanbefillingandlyophilizedinthesameequipmentalternatelywithotherssterileproductsafterinactivationordisinfectingprocess.Butafterthed