临床试验材料即兴制备PDA质量要求技术报告团队最近开展的一项基准测试表明，即兴制备（EP）技术广泛用于临床给药的小规模临床研究中，为各种剂型制备各种剂型。由于临床现场发生的剂量准备活动的质量要求并不总是明确的，随着研究人员越来越多地使用EP支持小规模临床研究，这一差距变得非常重要。虽然传统的CGMP系统可能不适用于此类区域，但仍必须有适当的控制措施来确保患者的安全。 第63号技术报告:临床试验材料即兴制备的质量要求描述了一个质量体系，该体系将以确保产品质量和患者安全的方式支持在非制造环境中制备临床试验材料。

A recent benchmarking exercise conducted by the PDA Quality Requirements for the Extemporaneous Preparation of Clinical Trial Materials Technical Report Team indicates that extemporaneous preparation (EP) techniques are widely used to prepare a variety of formulations for a variety of dosage forms for small-scale clinical studies where dosing is in-clinic. Since the quality requirements for dose preparation activities that occur at clinical sites are not always clear, this gap becomes very important as investigators are increasingly using EP to support small-scale clinical studies. While traditional CGMP systems may not be in place in such areas, there still must be appropriate controls in place to ensure patient safety. Technical Report No. 63: Quality Requirements for the Extemporaneous Preparation of Clinical Trial Materials describes a quality system that will support the preparation of clinical trial materials in a nonmanufacturing environment in a manner that will ensure product quality and patient safety.