欧盟原料药GMP认证检查项目.docVIP

欧盟原料药GMP认证检查项目 GMP Checklist for Active Pharmaceutical Ingredients (APIs) 本GMP 认证检查项目基于法规要求和个人经验。 This GMP checklist is based on regulatory requirements and personal experiences. I. 组织和人员Organization and Personnel A．质量部门责任Responsibilities of the Quality Unit (QU) 企业应当建立独立的质量部门，质量部门应当参与所有与质量有关的活动 There should be a QU that is independent of production. QU should be involved in all quality related matters. 质量部门负责所有物料、中间体和原料药的放行和拒收，以及所有与质量相关文件的审核和批准。 QU has the responsibility to release/reject all materials, intermediates, and APIs, reviews and approves all quality related docum