例如,三期临床的剂型应按常规生产药品要求进行表征,得到相同水平的保障。 2.12. Where production and/or quality controlis transferred from one site to another, the recommendations in the guidelinefor transfer of technology should be followed. 如果生产和/或质量控制要从一个场所转移至另一个场所,则应遵守...
例如,III期临床研究中的剂型应与常规生产产品的特性和特征相同。 2.12 Where production and/or quality control is transferred from one site to another, the recommendations in the guideline for transfer of technology should be followed. 如果生产和/或质量控制从一个场所转移到另一个场所,则应遵循技术转移...
例如,三期临床的剂型应按常规生产药品要求进行表征,得到相同水平的保障。 2.12. Where production and/or quality controlis transferred from one site to another, the recommendations in the guidelinefor transfer of technology should be followed. 如果生产和/或质量控制要从一个场所转移至另一个场所,则应遵守...
and hereby expressly disclaims, any liability related to the client carrying out Silliker's recommendations, if any, contained in this report.This report is furnished solely for the benefit of the above named client in connection with the auditing services indicated above and provided in accordance ...
2.12. Where production and/or quality controlis transferred from one site to another, the recommendations in the guidelinefor transfer of technology should be followed. 如果生产和/或质量控制要从一个场所转移至另一个场所,则应遵守...
2.12. Where production and/or quality controlis transferred from one site to another, the recommendations in the guidelinefor transfer of technology should be followed. 如果生产和/或质量控制要从一个场所转移至另一个场所,则应遵守技术转移指南中的建议。
3.1. The recommendations in this guidelineare applicable to investigational products for human and veterinary use. 本指南的建议适用于人用和兽用临床试验药品。 3.2. Although the focus is on medicinal(pharmaceutical) products, some of the principles may be applied to otherinvestigational products. ...
(e) Self-inspection report. 自检报告 (f) Follow-up action. 后续行动 (g) Quality audit. 质量审计 (h) Suppliers’ audits. 供应商审计 F. Summary 汇总 Brief summary of thefindings, and recommendations (whereapplicable). 简要汇总发现的问题和建议 G. Conclusions 总结 A statement regarding the GMP...
4.2 At the time of issue, this document reflected the current state of the art. It is not intended to be a barrier to technical innovation or the pursuit of excellence. The advice in this Aide-Memoire is not mandatory for industry. However, industry should consider PIC/S recommendations and...
orfacilitybeingauditednorforeventsoractionsoccurringpriororsubsequenttothisaudit.Sillikershallnotendorse, andherebyexpresslydisclaims,anyliabilityrelatedtotheclientcarryingoutSilliker'srecommendations,ifany,containedinthisreport. Thisreportisfurnishedsolelyforthebenefitoftheabovenamedclientinconnectionwiththeauditing...