WHO 第992号技术报告 附录4：保存时间研究通用指南.pdfVIP

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WHO第992号技术报告附录4：保存时间研究通用指南，2015

Annex4

Generalguidanceonhold?timestudies

1.Introductionandbackground概述和背景

2.Glossary术语

3.Scope范围

4.Aspectstobeconsidered要考虑的方面

Reference参考文献

1.Introductionandbackground概述和背景

Manufacturersshouldensurethattheproductsthattheymanufacturearesafe,

effectiveandofthequalityrequiredfortheirintendeduse.Systemsshouldbeinplace

toensurethatpharmaceuticalproductsareproducedaccordingtovalidatedprocesses

andtodefinedprocedures.Manufacturingprocessesshouldbeshowntobecapableof

consistentlymanufacturingpharmaceuticalproductsthatareoftherequiredquality

andthatcomplywiththeirspecifications.

生产商必须保证其生产的产品安全有效，具有其既定用途所需要的质量。应有一

个系统来保证药品是根据经过验证的工艺和既定的程序生产的。生产工艺应具备

持续生产出具有所需的质量，并符合其质量标准的药品的能力。

Goodmanufacturingpractices(GMP)requirethatarrangementsshouldbemadeto

ensurethatthedispensedrawmaterialsandpackagingmaterials,intermediate

products,bulkandfinishedproductsarestoredunderappropriateconditions.Storage

arrangementsshouldnothavedeleteriouseffectsonthesubsequentprocessing,

stability,safety,efficiencyorqualityofstartingmaterials,intermediateproductsand

bulkproductspriortofinalpacking.Maximumacceptableholdingperiodsshould

thereforebeestablishedtoensurethatintermediatesandbulkproductcanbeheld,

pendingthenextprocessingstep,withoutproducingresultsoutsidetheacceptance

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criteriaforthequalityofthematerial.Normally,intermediateandbulkproducts

shouldnotbestoredbeyondtheestablish