抽样与检验项目旨在监督欧洲市场上的集中审评药品质量,由欧盟委员会(European Commission)、欧洲药品管理局(European Medicines Agency)、欧洲药品质量管理局(European Directorate for the Quality of Medicines,EDQM)和官方药品质量控制实验室网络(network of Official Medicines Control Laboratories,OMCLs)共同发起于1997年,从1997-1998试点计划检验的9个药品稳定增加至2017年的58个,总计检验超过700个药品。EDQM根据检验项目决定取样数量后,从欧盟/欧洲经济区(EU/EEA)三个国家中取样,并交由OMCLs检验,通常化学药品和胰岛素样药品由一个实验室检验,非化学药品由两个实验室检验。
检验项目的选择基于负责审评药品卷宗的专家(Rapporteur and co-Rapporteur)的建议,他们对产品深入的理解使得他们能够选出产品最为关键的检验项目。检验项目通常被分为五类:
Category 分类
Parameters 项目
A
Tests related to the determination of active substance/preservatives content and potency; this also includes the tests for uniformity of content 和原料药/防腐剂含量和效价相关的测定,也包括含量均匀度的检验
B
Tests performed to assess the purity of the medicinal product and/or the integrity of the active substance (e.g. related substances, residual solvents, molecular size distribution) 药物和/或活性物质纯度(如有关物质、残留溶剂、分子大小分布)的评估
C
All tests linked to physical/pharmaceutical characteristics (uniformity of mass, disintegration of tablets, appearance, colour, clarity); this category also includes the tests for water content, particulate matters and particle size 物理/制药特性(质量均匀度、片剂崩解、外观、颜色、澄清度)相关的检验,也包括水分、颗粒物和粒度检验