问:对于外包装上没有标识储存条件的药品,不监测储存条件是否可以接受? ANSWER: No. According to the Guideline ondeclaration of storage conditions (CPMP/QWP/609/96 Rev. 2), marketingauthorisation holders have to provide stability data for storage conditions at25°C / 60% relative humidity (RH), or...
EMA 特殊药品和原料药的存储条件 2007.11.19 英文.pdf,European Medicines Agency London, 19 November 2007 CPMP/QWP/609/96/Rev 2 COMMITTEE FOR HUMAN MEDICINAL PRODUCTS (CHMP) GUIDELINE ON DECLARATION OF STORAGE CONDITIONS: A: IN THE PRODUCT INFORMATION OF MED
treatment during growth with pesticides etc., and drying and storage conditions should be included. It should be confirmed that an adequate quality assurance system for the collection and/or cultivation, harvest and primary processing according to the ‘Guideline on good agricultural ...
guideline CPMP/QWP/ 122/02, rev.1, was revised in the paragraph 2.1.1 General to clarify the need for testing under accelerated or, where applicable, intermediate storage conditions. Revision in December 2003: The guideline CPMP/QWP/ 122/02, corr. was revised to be brought in line with ...
The principles for the choice of sterilisation process for finished products and containers are presented in the form of decision trees in section 5 of this guideline. The principles of the decision trees may also be applied for the sterilisation of active substances and excipients. ...
This is termed “extended pharmaceutical equivalence” for the purpose of this guideline. 如适用,质量的等效性可以通过与参照药物产品(即已上市药物制剂)的对比数据建立,包括:药物剂型、定性和定量组成、显微结构/物理性质、产品性能、给药方式。在本指南中,这被称为“扩展的药物等效性”。 Equivalence with ...
Further details on the information to be provided are outlined in this guideline. 在通用技术文件模块3上市许可申请文件关于生产方法的描述要求在这份指令的附件1第1部分(3.2.2.3节)有说明。更多详细的信息在这份指南中有提供。 4. Manufacture 生产 The headings of this guideline follow the structure of ...
The headings of this guideline follow the structure of the CTD format Module 3, Section 3.2.P.3 Manufacture. 这份指南的标题遵循CTD模块3下3.2.P.3节 生产 的结构。 Only product specific aspects of manufacture need to be described and included in the MA dossier; general elements of Good Manufac...
theproposedcontrolstrategyandprocessvalidation.Theguidelinealsoaddressesaspectsrelatedtooutsourcingandnewmanufacturingpracticessuchascomplexmanufacturingchainsorissueswithprolongedholdingtimesandtransportationconditions.Detailedinformationaboutrequirementsofthesterilisationprocessisprovidedinaseparateguideline.制剂成品生产指南的目的是...
The essence of the requirements described in the chapters of this guideline can be found in the two decision trees for sterilisation of products in diverse administration forms (aqueous liquid; non-aqueous liquid, semi-solid, dry powder). ...