產(chǎn)品生產(chǎn)工藝規(guī)程編制及管理規(guī)程

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3、intsSelectionParagraphFormatLineSpacingLinesToPointselectionParagraphFccccccccccccccccccccccccccccccccccccccccccccccccccccccccormatLineSpacingLinesToPointsSelectionParagraphFormatLineSpacingLinesToPoctionParagraSelec工藝規(guī)程編制管理規(guī)程SMP.JS-GY-002目的建立產(chǎn)品生產(chǎn)工藝規(guī)程編制管理規(guī)程，明確工藝規(guī)程編制及管理的內(nèi)容及要求，使產(chǎn)品生

4、產(chǎn)工藝規(guī)程規(guī)范化，標(biāo)準(zhǔn)化。范圍本公司產(chǎn)品的生產(chǎn)工藝規(guī)程責(zé)任質(zhì)量副總經(jīng)理、生產(chǎn)技術(shù)部經(jīng)理、生產(chǎn)技術(shù)部工藝員內(nèi)容1生產(chǎn)工藝規(guī)程的定義規(guī)定為生產(chǎn)一定數(shù)量成品所需起始原料和包裝材料的數(shù)量，以及工藝、加工說明、注意事項(xiàng)，包括生產(chǎn)過程中控制的一個或一套文件。2說明2.1闡述生產(chǎn)一定量的某一藥品所需原、輔、包裝材料、半成品和成品的質(zhì)量標(biāo)準(zhǔn)以及批生產(chǎn)處方、生產(chǎn)規(guī)程、作業(yè)方法、中間控制方法和注意事項(xiàng)的一個或一套文件。2.2生產(chǎn)工藝規(guī)程是藥品生產(chǎn)和質(zhì)量控制中最重要的文件；它囊括該產(chǎn)品的各項(xiàng)技術(shù)參數(shù)、工藝條件與質(zhì)量標(biāo)準(zhǔn)。2.3生產(chǎn)工藝規(guī)程制訂必須通過工藝驗(yàn)證的結(jié)果來確認(rèn)。2.

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