forandusedbyeitherpeopleorgoods. 设置于两个或数个房间之间(如不同洁净级别的房间之间)的具有两扇或多扇门的隔离空间。 设置气锁的目的是在人员或物料出入其间时,对气流进行控制。气锁有人员气锁和物料气锁 之分。 BATCH(ORLOT)批 Adefinedquantityofstartingmaterial,packagingmaterialorproductprocessedin ...
3.1.3Business Development should discuss costs with customer for chosen design including number of colors, special cut-outs, embossing, and varnishing. 3.2Text 3.2.1Text should comply with all applicable guidelines for dietary supplements. Customer is responsible for ensuring compliance. 3.2.2At a mi...
This document provides guidance for the interpretation of the principles and guidelines of good manufacturing practice (GMP) for medicinal products as laid down in Directive 2003/94/EC for medicinal products for human use and Directive 91/412/EEC for veterinary use.欧盟GMP指 第5章生产(中英EU GMP...
This document provides guidance for the interpretation of the principles and guidelines of good manufacturing practice (GMP) for medicinal products as laid down in Directive 2003/94/EC for medicinal products for human use and Directive 91/412/EEC for veterinary use. Status of the document: ...
An effective material system is a key requirement of the GMP guidelines. 2.物料系统的有效管理可以确保产品质量和安全。 Effective management of material system can ensure product quality and safety. 3.合格的物料供应商对保障产品质量至关重要。 Qualified material suppliers are crucial to ensuring product...
(f) GMP guidelines used for assessing compliance. 用于评估符合性的GMP指南 (g) For foreign inspections state whether, the national regulatory authority (NRA) of the country where the inspection took place was informed and whether it took part in the inspection. 进行海外检查时,是否通知被检查企业所...
设置于两个或数个房间之间(如不同洁净级别的房间之间)的具有两扇或多扇门的隔离空间。设置气锁的目的是在人员或物料出入其间时，对气流进行控制。气锁有人员气锁和物料气锁之分。BATCH (OR LOT)批 A defined quantity of starting material, packaging material or product processed in one process or series of ...
1.1.In view of an old publication date,and the recent need for new guidelines arising from inspections carried out forCOVID-19 therapeutics, the World Health Organization (WHO) PrequalificationTeam-Inspection Services (PQT INS) raisedthe urgency for a revision of the WHO Good manufacturing practice...
This document provides guidance for the interpretation of the principles and guidelines of good manufacturing practice (GMP) for medicinal products as laid down in Directive 2003/94/EC for medicinal products for human use and Directive 91/412/EEC for veterinary use. 指南细则出版的立法基础:2001/83...
Please review and abide by the requirements of the Mattel GMP and ProductQuality Guidelines.Disseminate GMP and Product Quality requirements to ensure that allFacilities involved in Mattel-branded production h 4、ave been fully informed about the expectations andthe importance of compliance.请审查并遵守...