(b) Adequate laboratory facilities for the testing and approval (or rejection) of components, drug product containers, closures, packaging materials, in-process materials, and drug products shall be available to the quality control unit. 质量管理部门应具有足够的实验室设施,用于检测和批准(或拒收)各种...
Definitions5定义 Materialsofconstruction6refertothesubstances(e.g.,glass,highdensitypolyethylene(HDPE)resin,metal)usedtomanufactureapackagingcomponent.组成材料是指用来生产包装组件的物质(例如玻璃,HDPE树脂,金属) Apackagingcomponentmeansanysinglepartofacontainerclosuresystem.Typicalcomponentsarecontainers(e.g.,ampules...
(Internet)http://.fda.gov/cber/guidelines.htm U.S.DepartmentofHealthandHumanServices FoodandDrugAdministration CenterforDrugEvaluationandResearch(CDER) CenterforBiologicsEvaluationandResearch(CBER) May1999 TableofContents I.INTRODUCTION...1 II.BACKGROUND...2 A.Definitions...2 B.CGMP,CPSCandUSPRequirem...
Any production activities (including weighing, milling, or packaging) of highly toxic nonpharmaceutical materials, such as herbicides and pesticides, should not be conducted using the buildings and/or equipment being used for the production of APIs. Handling and storage of these highly toxic non...
(b) Adequate laboratory facilities for the testing and approval (or rejection) of components, drug product containers, closures, packaging materials, in-process materials, and drug products shall be available to the quality control unit. 质量管理部门应具有足够的实验室设施,用于检测和批准(或拒收)各种...
校验5.4ComputerizedSystems计算机控制系统6.DOCUMENTATIONANDRECORDS文件和记录6.1DocumentationSystemandSpecifications文件系统和质量标准6.2EquipmentcleaningandUseRecord设备的清洁和使用记录6.3RecordsofRawMaterials,Intermediates,APILabelingandPackagingMaterials原料、中间体、原料药的标签和包装材料的记录6.4MasterProduction...
Annex7ManufactureofHerbalMedicinalProducts植物药生产Annex8SamplingofStartingandPackagingMaterials原辅料、包装材料的取样 Annex9ManufactureofLiquids,CreamsandOintments液体、霜剂和油膏的生产 ANNEXES欧盟GMP-附录Annex1Manufactureof27欧盟GMP-附录续Annex10ManufactureofPressurisedMeteredDoseAerosolPreparationsforInhalation吸入式...
system interd for raw materials, in-process materials, and the finished dosage form suitable for administration. It is one of a series of guidelines covering topics relevmt to the mnufacturing and controls portion of investigational new drug applications (ms), new drug applications (NIXs), and...
system proposed for marketing (including, as appropriate, any secondary packaging andContains Nonbinding Recommendations9container label). Any available studies carried out on the drug product outside its immediatecontainer or in other packaging materials can form a useful part of the stress testing of...
Food and Drug Administration (FDA) is regulation of components of food contact materials, including packaging. Once known as indirect food additives, FDA now refers to these materials as food contact substances (FCS). In an effort to ensure the safe use of these substances, FDA has established...