Table 2 Current practical guidelines

Good Clinical Practice (GCP)-guidelines comprise proper study design, generation of credible research data, and safety for study participants, and correct data management. These issues are assessed by a competent authority such as a medical ethics committee. Manufacturing of investigational medicinal products is highly complex. Good Manufacturing Practice (GMP) guidelines intent to ensure consistency between batches and adequate documentation of the development and production of the investigational medicinal products. The GMP Annex 13 comprises practical guidelines on the quality, production, quality control, packaging, labelling and shipping of the Active Pharmaceutical Ingredient (API) and the drug product.

In order to ensure GMP conditions, all information concerning the topics mentioned in the Annex 13 have to be documented in an Investigational Medicinal Product Dossier (IMPD). Additionally, in the EU each product batch needs to be released by a Qualified Person before the investigational medicinal product is admitted to a clinical trial.