关于EudraGMDP中的这段话是什么意思呢？？

beiwei5du

大家好！最近开始了解国外的相关的GMP信息，想咨询一下Users are advised that since inspections of manufacturers of active substances are based on risk, some active substance manufacturers may not be in possession of a GMP certificate issued by an EEA authority. The absence of a GMP certificate should not be understood as meaning that the active substance manufacturer in question does not comply with GMP.”是指什么意思呢？是否说部分合法原料供应商并没有欧盟的GMP证书（什么情况下需要具备GMP证书，什么情况下不需要具备呢？）？是否可进一步理解为本数据库并不包含所有的在欧盟合法经营的制药企业呢？那么对于在欧盟合法经营制剂企业，是否必须具有欧盟GMP证书呢？？

newfellow

意思就是没有证书不一定就是不符合EU GMP

newfellow

审计的决定是基于风险考虑, 换句话说如果官方认为是低风险（个人经验就是全合成且关键物料不涉及到微生物、动物或者血液制品）的，一般会拒绝审计。