[Pharmaceutical involvement in academic clinical trials: Quality assessment of pharmaceutical manufacturing operations].

Introduction: For academic clinical trials, the hospital pharmacy may be required to perform the specific activity of preparing investigational drugs.

Material And Methods: With regards to such activity, and in light of the recent changes in the regulatory environment, the main objective of this study was to evaluate whether quality levels and traceability were in compliance with the applicable regulatory standards. In order to do so, two internal audits have been conducted, the first on the compliance of operations with existing regulatory standards and the second on the quality of traceability of the operations.