procedure to prevent any person who has an apparent illness from entering areas in which they may adversely affect the quality of the product or affect their own health 12 Section 10 22 Is smoking eating drinking and chewing prohibited in production storage and laboratory areas 9 REF WHO 32 ...
GMP附录中英文对照.pdf,《药品生产质量管理规范(2010 年修订)》《Good Manufacturing Practice (2010 revision) 》 Annex1 to Annex5 Technical Reviewed by ISPE Michael Lee, Zhao Chunhua Zhao Yunxia, He Guoling, Ji Yiyun Initial Translation from NNE Pharmaplan
ANNEX 1 附件1 MANUFACTURE OF STERILE MEDICINAL PRODUCTS 无菌医药产品的生产 Principle 原则 The manufacture of sterile products is subj
需要金币:*** 金币(10金币=人民币1元) WHO医用气体GMP指南(2021草案).pdf 关闭预览 想预览更多内容,点击免费在线预览全文 免费在线预览全文 Working document QAS/21.875 February 2021 DRAFT WORKING DOCUMENT FOR COMMENTS: Good manufacturing practices for medical gases Please send your comments to Dr Sabine...
there is a procedure for Self-Inspection and/or quality audit which regularly appraises the effectiveness and applicability of the Quality Assurance system. 三、药品生产质量管理规范(GMP)Good Manufacturing Practice for Medicinal Products GMP 是质量保证的一部分,它确保药品始终按照适合于其使用目的的质量...
Harvesting:theprocedurebywhichthecells,inclusionbodiesor crudesupernatantscontainingtheunpurifiedactiveingredientare recovered. 收获:含有未纯化的活性成分的细胞、包涵体或未经处理的上清液的回收过 程。 Hybridoma:animmortalizedcelllinethatsecretesdesired (monoclonal)antibodiesandwhichistypicallyderivedbyfusing ...
Where the CCS indicates that the risk of contamination is high, separate change Current Annex 1-2008 should be sterilised and passed into the area through double-ended sterilisers sealed into the wall, or by a procedure which achieves the same objective of not introducing contamination. Non- ...
there is a procedure for Self-Inspection and/or quality audit which regularly appraises the effectiveness and applicability of the Quality Assurance system. Good Manufacturing Practice for Medicinal Products (GMP) Good Manufacturing Practice is that part of Quality Assurance which ensures that products ...
1.302 §211.25(a) Does each employee receive retraining on an SOP (procedures) if critical changes have been made in the procedure? 1.303 Indicate how on-going, periodic GMP training is accomplished. 1.304 §211.25 is all training documented in writing that indicates the date of the training, ...
But the quality unit does not necessarily need to review the detailed procedure on how that preventative maintenance is done. The same thing for housekeeping, where the quality unit should review the procedure defining how often, whos going to do it, that sort of thing, but the details of ...