生物制品gmp檢查指南-閱讀頁
2025-04-19 23:37本頁面
【正文】 ntaminated with pathogen during the manufacturing of bioproduct those are isolated from sterile materials and equipments and the contaminated materials and equipments are marked with obvious indications. 4. 物料 MATERIAL224。Is the strong strain to be verified, stored, controlled, distributed and destroyed in pliance with provision?224。In case of that the raw materials are from animals which to be applied in the manufacture of bioproducts, it must be detailed recorded. The content of records should include the origin area where the animals e from, the conditions of breeding and raising, the health condition of animals etc. at least. 224。Whether the animal to be applied in the vaccine production those are SPF animals. 224。Whether it had established the Primary Seed Lot, Master Seed Lot and Working Seed Lot system for the strong strain production. 224。Are there primary source, characteristic identification and reproducing pedigree of strong strain in the seed Lot system? Whether the strong strain is unitary purified microorganism and relevant production and breeding specifications. Is there integrate documents about the optimal storage condition? 224。Are there primary cell bank, master cell bank and working cell bank system to be established for the production? 224。Whether the cell bank system include: primary source of cell bank (karyotype analysis, tumorincurring), colony multiplication quantity, reproducing pedigree, and whether the cells belong to unitary purified cell line, the preparation procedure, the optimal storage condition etc. 5. 衛(wèi)生 CLEANESS amp。 5002：在含有霍亂弧菌、鼠疫菌、人免疫缺陷病毒（HIV）、乙肝病毒等高危病原體的生產(chǎn)操作結(jié)束后，對(duì)可疑的污染物品是否在原位消毒，并單獨(dú)滅菌后，方可移出工作區(qū)。 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(dòng)物的區(qū)域到其他制品或微生物的操作區(qū)域。 5305：從事生物制品生產(chǎn)操作的人員是否與動(dòng)物飼養(yǎng)人員分開。 5602：生物制品生產(chǎn)及維修、檢驗(yàn)和動(dòng)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。 5603：患有傳染病、皮膚病、皮膚有傷口者和對(duì)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。 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)。 ＊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。 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。 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)。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。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。 NEGATIVE EFFECT12. 自檢 SELFINSPECTION7 / 7
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