Abstract

Successful GxP Practice

Dirk Sawitzky, Quality Manager Non Clinical Test Facility, Universität Leipzig

During the development of a medicinal product for human or veterinary use, safety, quality and efficacy of the product has to be demonstrated in non-clinical and clinical trials. Of these, trials concerning safety must comply with the principles of “Good Laboratory Practice” (GLP) for nonclinical trials and “Good Clinical Practice” (GCP) for clinical trials, respectively. While GLP and GCP apply to trials demonstrating safety of a medicinal product, manufacturing has to take place in accordance with the guidelines for “Good Manufacturing Practice” (GMP) as described in the Guide to Good manufacturing practice.& With guideline 2013/C 68/01 on “Good Distribution Practice of Medical Products for Human Use”, principles to control distribution and ensure quality and integrity of medicinal products were laid down. Based on the regulation 1394/ 2007 EC the GxP system applies as well to cell-based medicinal products like advanced therapy medicinal products (ATMPs), i.e. a gene therapy medicinal product, a somatic cell therapy medicinal product, or tissue engineered products.