Classifying data according to different criticality can make sense. This is also indicated, for example, in the concept paper on the amendment of EU-GMP Annex 11. 根据不同的关键程度对数据进行分类是有意义的。例如,关于EU-GMP附录11修订的概念文件也指出了这一点。 "[6] Guidelines should be includ...
GMP (Good Manufacturing Practice) is a set of guidelines that ensures the quality and safety of pharmaceutical products. As a pharmaceutical company, we have a responsibility to comply with GMP regulations, including the proper storage and monitoring of drugs in our warehouse. One important aspect ...
Reasons for returns 12.您是按照药品GMP(2010年修订)要求组织库房(管理)的吗? Do you organize your warehouse properly according to the GMP Guidelines (revised in 2010)? a. 货物接收程序是怎样的?检查清单中有哪些主要内容? What is the procedure for the goods reception? Which elements are included in...
9. For the warehouse, do we need strictly to store APIs, excipients, and packaging materials separately? 库房存储,我们是否要严格区分原辅料、包材? A. 是 Yes B. 否 No 10. For QC positive test and strain passage, can they be settled in the same room? 质控的阳性检测和菌种传代可以设置在...
traceability is maintained; The transportation of the finished product of the company is completed by the carrier company, the sales department is responsible for signing the transportation agreement with the carrier company, and the warehouse clerk is responsible for the issuance of the finished ...
工作组正在修订并合并“PI 019: PIC/S Site Master File for Source Plasma Establishments”和“PI 020: PIC/S Site Master File for Plasma Warehouses”。合并修订后的场地主文件将和PIC/S 场地主文件(SMF)模板保持一致。 PI 006 验证主计划,安装和运行确认,非无菌工艺验证,清洁验证修订工作组 ...
'[6] Guidelines should be included for classification of critical data and critical systems.' “[6]指导文件中应该要包含关键数据和关键系统的分类原则。” In principle, it can certainly be stated that all GMP-relevant data are critical in different ways. The decisive factor is whether data are ...
Layouts of warehouses and storage areas, with special areas for the storage and handling of highly toxic, hazardous and sensitizing materials indicated, if applicable; The warehouse floor plan is shown in Figure 4-1. *** Figure 4-1: Warehouse floor plan Brief description of speci...
New Chiese GMPs identifies the responsibility of top management personnel for the implementation of ...
Dormitories must be separated from production and warehouse buildin 宿舍必须与生产车间和仓库分开。b. Dormitories, canteens, and bathrooms must be safe, sanitary and meet the basic needs of employees.宿舍和餐厅必须安全、卫生并能满 33、足员工的基本需求。8. Workplace Safety工作场所安全a. The ...