PDA Technical Report No. 63 (TR 63) Quality Requirements for the Extemporaneous Preparation of Clinical Trial Materials (single user digital version)

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.

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