包装材料密封性研究的国外法规及技术要求

美国2018年颁布药典 USP 42-1207

无菌产品在其保质期内需得到好的屏障，要求包装须良好的密封完整性.

  USP 42-1207     无菌产品包装完整性评估

  USP 42-1207.1 包装完整性和测试方法选择

  USP 42-1207.2 包装完整性泄漏测试技术

  USP 42-1207.3 包装封口质量测试方法

美国 FDA 颁布<CFR, Title 21,Chapter I,Section§211.94(b), Section §600.11(h)>

澳大利亚

Therapeutic Goods Administration (TGA) of Department of Health andAgeing

颁布<TherapeuticGoods Regulations 1990 (Therapeutic Goods Act 1989) >

巴西

National Health Surveillance Agency (ANVISA) of Ministry of Health 颁布< Resolution RDC 17/2010 (Drug GMP) Market Regulations>

加拿大Therapeutic Products Directorate and Biologics and Genetic herapiesDirectorate, Health Products and Food Branch of Health Canada 颁布<Food and Drugs Regulations

(Food and DrugsAct) >

欧盟

Respective regulatory body in each country 颁布<EudraLex from European Commission >