附录2 WHO药品GMP指南_中英文_.pdf,Annex 2 WHO good manufacturing practices for pharmaceutical products: main principles 附录2 WHO药品GMP:主要原则 Introduction引言 General considerations总则 Glossary术语 Quality management in the medicines industry: philo
The system must continuously be maintained meaning that the sanitization also has be performed when no production is running or when no water is used for production. 第 6.12 段提供了有关要求的详细指导。重要的是,系统的设计应允许进行例行消毒/杀菌,并制定程序,对反渗透系统进行定期的预防性消毒或杀菌...
In the following definitions, the term 'data' includes raw data.在以下定义中,术语“数据”包括原始数据 Metadata: 元数据(属性数据) Metadata is data that describe the attributes of other data,and provide context and meaning. Typically, these are datathat describe the structure, data elements, inter...
数据完整性的范畴包括所有数据在整个数据生命周期中的全 completeness, content and meaning of data is retained 面性,一致性和准确性的程度。 throughout the data lifecycle. 数据完整性的设置必须在整个数据生命周期中 , 保持数据的准 确,完全, 以及内容和含义。 Data governance The sum total of arrangements ...
4. Abbreviati ons 缩略词The meaning of the abbreviati ons used in this sta ndard is as follows:GMP Good Manu facturi ng Practices.DGIS Directorate General for Health In puts.FEUM Pharmacopoeia of the Un ited Mexica n States.Official Mexica n Sta ndard NOM.SOP Sta ndard Operati ng ...
has been found is to see if it can be stated in terms that are directly actionable, meaning ...
Meaning: Functionality is documented by IT with a fewsamples.A: Very correct!问:我想,我刚才问问题时没讲的太清楚:是否只是审核定期审核的时间间隔内,该流程仍在起作用---因而,是否仍有记录下审计追踪数据?也就是说,由IT记录采用少数样本来记录其功能。
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...
InternationalNonproprietaryNames(INN)forpharmaceuticalsubstances designatedbyWHOshouldbeusedwhenavailable,togetherwithother designatednames. Glossary Thedefinitionsgivenbelowapplytothetermsusedinthisguide.Theymayhave differentmeaningsinothercontexts. activepharmaceuticalingredient(API).Anysubstanceormixtureof ...
FDA’s use of the term backup is consistent with the term archive as used in guidance for industry and FDA staff General Principles of Software Validation. FDA在行业指南和软件验证一般原则草案中对 “备份” 一词与 “归档” 一词的使用是一致的。