PIC/S审计清单(Audit Checklist)是PIC/S对药品监管机构进行GMP监管体系评估的指标体系,该指标体系共有11个模块,细分为38项亚指标[3],其中模块5检查程序包含6项亚指标,围绕实施检查的过程展开评估,包括检查策略、检查前准备、检查报告格式和内容、...
•Drugqualityisaresponsibilitytosociety:necessity 药品是用来治病救人的，Thedrugsareusedtosavelives药品是为了延长人类的生命，Drugsistoprolonghumanlife,药品是为了提高人类的生活质量，Thedrugsaredesignedtoimprovethequalityofhumanlife,药品生产企业必须对病人负责，Drugmanufacturersmustberesponsibleforthepatient,药品生产...
Good Manufacturing Practices (GMP) andcurrent Good Manufacturing Practices (cGMP)are, in most cases, interchangeable. GMP meaning the basic regulation promulgated by the US Food and Drug Administration (FDA) under the authority of theFederal Food, Drug, and Cosmetic Actto ensure that manufacturers ar...
the audit may be conducted only by reviewing documents. In this case, the validity period of the certificate of conformity issued as a result of the audit is calculated in the same manner as the validity period of other manufacturers and...
Qualitydepartmenthastheresponsibilitytoperformthe audittoassesthequalitysystemofthemainvendorwithrelateddepartments –WHOGMP第8.8条:质量管理负责人有义务协同其他部门批准能提供符合要求的起始原料和包装材料的供应商,WHOGMPitem8.8: Qualitymanagementhavetheresponsibilitywithrelateddepartmentstoapprove themanufacturers,they...
The APIC Audit Program has been completely revised to bring it in line with EMEA's guidance on the responsibility of auditing active substances manufacturers by the Manufacturing Authorization Holders for medicinal products in Europe. This audit programme now provides a third party option for auditing...
Audit Trail: 审计追踪An audit trail is a process that captures details such as additions, ...