生物制品gmp檢查指南-資料下載頁
2025-04-04 23:37本頁面
【正文】 f working area after individual sterilization. 224。 5303：在生物制品生產(chǎn)日內(nèi)，生產(chǎn)人員是否按明確規(guī)定的方法去污染處理后，由操作活微生物或動物的區(qū)域到其他制品或微生物的操作區(qū)域。In the manufacture day of bioproduct, whether the personnel to be decontaminated according to the established provision and only after this they are permitted to enter others ordinary working areas from the working area of microorganism or animal related materials. 224。 5305：從事生物制品生產(chǎn)操作的人員是否與動物飼養(yǎng)人員分開。Whether the production personnel that engage in the bioproduct manufacture whom to be isolated from animal breeding personnel. 224。 5602：生物制品生產(chǎn)及維修、檢驗(yàn)和動物飼養(yǎng)的操作人員、管理人員，是否接種相應(yīng)疫苗并定期進(jìn)行體檢。Whether the operators and management personnel who engage in the bioproducts manufacture, inspection and animal breeding who accept the relevant vaccination and physical examination periodically. 224。 5603：患有傳染病、皮膚病、皮膚有傷口者和對生物制品質(zhì)量產(chǎn)生潛在的不利影響的人員，是否進(jìn)入生產(chǎn)區(qū)進(jìn)行操作或進(jìn)行質(zhì)量檢查。Whether the personnel with infectious disease, skin disease, or with body lesion etc. that has potential negative influence to the quality of bioproducts who enter the production area or participate in the process or inspection. 6. 驗(yàn)證 VALIDATION7. 文件 DOCUMENT8. 生產(chǎn)管理 PRODUCTION MANAGEMENT224。 6602：生物制品是否嚴(yán)格按照《中國生物制品規(guī)程》或國家藥品監(jiān)督管理部門批準(zhǔn)的工藝方法生產(chǎn)。Whether the bioproducts to be manufactured strictly pursuant to the “China Bioproduct Manufacture Procedure” or the procedure approved by SFDA. 224。 ＊7005：無菌藥品生產(chǎn)直接接觸藥品的包裝材料是否回收使用。Whether the package material which to contact with sterile pharmaceutical product directly that to be recycled. 9. 質(zhì)量管理 QUALITY MANAGEMENT224。 7404：生物制品原輔料（包括血液制品的原料血漿）、原液、半成品、成品是否嚴(yán)格按照《中國生物制品規(guī)程》或國家藥品監(jiān)督管理部門批準(zhǔn)的質(zhì)量標(biāo)準(zhǔn)進(jìn)行檢定。Whether the raw materials of bioproduct (including plasma which to be used in blood preparation), primary liquid, intermediate product, final product those to be inspected strictly according to “China Bioproduct Inspection Procedure” or specification standard approved by SFDA.224。 7405：生物制品國家標(biāo)準(zhǔn)品是否由國家藥品檢驗(yàn)機(jī)構(gòu)統(tǒng)一制備、標(biāo)化和分發(fā)。生產(chǎn)企業(yè)是否根據(jù)國家標(biāo)準(zhǔn)品制備其工作品標(biāo)準(zhǔn)。Whether the bioproduct national standard sample to be prepared, standardized and distributed from national drug inspection institute in unification. Whether the manufacturers formulate their standard working sample pursuant to the specification of national standard sample. 224。 7602：生物制品生產(chǎn)用物料是否對供應(yīng)商進(jìn)行評估并與之簽訂較固定合同，以確保其物料的質(zhì)量和穩(wěn)定性。Is there assessment for the suppliers of the materials which to be applied in the bioproduct manufacture, and to establish the fixed contract with those suppliers who have been approved, thus in this way to ensure the stable quality of materials? 10. 產(chǎn)品銷售與收回 FINAL PRODUCT DISTRIBUTION amp。 CALLBACK11. 投訴與不良反應(yīng)報告THE REPORT ABOUT CLIENT COMPLAIN amp。 NEGATIVE EFFECT12. 自檢 SELFINSPECTION7 / 7
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