【正文】 ................................................................................... 8 操作間空氣微生物計(jì)數(shù) .............................................................................................................. 8 操作間、設(shè)備、操作人員表面微生物計(jì)數(shù) ........................................................................ 8 操作間壓差 ..................................................................................................................................... 9 操作間清潔、清場(chǎng) ....................................................................................................................... 9 公用介質(zhì) ................................................................................................................................................. 10 純水 .................................................................................................................................................10 壓縮空氣 ........................................................................................................................................10 原輔料、包裝材料 ............................................................................................................................... 11 質(zhì)量 .................................................................................................................................................11 貯存條件 ........................................................................................................................................11 設(shè)備 ........................................................................................................................................................... 11 設(shè)備清潔 ........................................................................................................................................11 泰康顆粒劑工藝驗(yàn)證方案 共 23頁(yè)，第 3頁(yè) 設(shè)備維護(hù)保養(yǎng)和運(yùn)行狀況 .......................................................................................................12 工藝文件 ................................................................................................................................................. 12 工藝文件的正確性 .....................................................................................................................12 操作指令的明確性 .....................................................................................................................13 生產(chǎn)指令的正確性 .....................................................................................................................13 原輔料粉碎工藝變量 .......................................................................................................................... 13 預(yù)混合工藝變量 ................................................................................................................................... 14 制粒工藝變量 ........................................................................................................................................ 14 總混工藝變量 ...................................................................................................................................... 15 內(nèi)包裝工藝變量 ................................................................................................................................. 16 外包裝 .................................................................................................................................................... 16 產(chǎn)品外觀 .....................................................................................................................................16 成品質(zhì)量檢驗(yàn) ............................................................................................................................17 印刷包材料的物料平衡 .........................................................................................................17 產(chǎn)成品總物料平衡 ...................................................................................................................17 質(zhì)量保證 ............................................................................................................................................... 18 文件 完整 .....................................................................................................................................18 正確的檢驗(yàn)方法 ..