工藝規(guī)程的編制與管理規(guī)程

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3、ctionParagraphFormatLineSpacingLinesToPointselectionParagraphFccccccccccccccccccccccccccccccccccccccccccccccccccccccccormatLineSpacingLinesToPointsSelectionParagraphFormatLineSpacingLinesToPoctionParagraSelec工藝規(guī)程的編制與管理規(guī)程目的：建立工藝規(guī)程的編制和管理規(guī)程，明確工藝規(guī)程編制的內(nèi)容要求及管理程序，使其規(guī)范化、標(biāo)準(zhǔn)化、程序化。范圍：每個(gè)正式批準(zhǔn)，投入正

4、式生產(chǎn)的藥品都應(yīng)有完整的工藝規(guī)程。責(zé)任：生產(chǎn)部負(fù)責(zé)制訂；質(zhì)保部負(fù)責(zé)審核；主管生產(chǎn)的副總經(jīng)理批準(zhǔn)；工藝規(guī)程的編制與管理人員執(zhí)行。內(nèi)容：1.總則1.1工藝是生產(chǎn)產(chǎn)品的具體方法，是把人、機(jī)、料、環(huán)四大因素，在特定條件下結(jié)合起來(lái)，把靜態(tài)因素變?yōu)閯?dòng)態(tài)生產(chǎn)過(guò)程的手段。工藝方法的先進(jìn)性、可行性、嚴(yán)肅性和相對(duì)穩(wěn)定性，是保證產(chǎn)品質(zhì)量的重要因素。工藝方法用文字、圖表或其他載體確定下來(lái)，就是工藝文件。制藥工業(yè)的主要工藝文件之一是工藝規(guī)程。SelectionParagraphFormatLineSpacingLinesToPointsSelectionParagraphFormatLi

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