Validation and qualification activities are nowadays an integral part of the day by day routine work in a radiopharmacy. This document is meant as an Appendix of Part B of the EANM “Guidelines on Good Radiopharmacy Practice (GRPP)” issued by the Radiopharmacy Committee of the EANM, covering the qualification and validation aspects related to the small-scale “in house” preparation of radiopharmaceuticals. The aim is to provide more detailed and practice-oriented guidance to those who are involved in the small-scale preparation of radiopharmaceuticals which are not intended for commercial purposes or distribution. The present guideline covers the validation and qualification activities following the well-known “validation chain”, that begins with editing the general Validation Master Plan document, includes all the required documentation (e.g. User Requirement Specification, Qualification protocols, etc.), and leads to the qualification of the equipment used in the preparation and quality control of radiopharmaceuticals, until the final step of Process Validation. A specific guidance to the qualification and validation activities specifically addressed to small-scale hospital/academia radiopharmacies is here provided. Additional information, including practical examples, are also available.

中文翻译：

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涉及放射性药物的工艺和操作的验证和鉴定指南。

如今，验证和鉴定活动已成为放射性制药日常工作不可或缺的一部分。本文件是 EANM 放射性药物委员会发布的 EANM“良好放射性药物实践指南 (GRPP)”B 部分的附录，涵盖与小规模“内部”制备相关的资格和验证方面。放射性药物。其目的是为那些参与小规模制备不用于商业目的或分销的放射性药物的人员提供更详细和以实践为导向的指导。本指南涵盖了遵循众所周知的“验证链”的验证和资格活动，从编辑一般验证总体规划文档开始，包括所有必需的文档（例如用户需求规范、资格协议等），并引导放射性药物制备和质量控制所用设备的鉴定，直至工艺验证的最后一步。这里提供了专门针对小型医院/学术界放射性药剂学的资格和验证活动的具体指南。还提供其他信息，包括实际示例。