Context and challenges
This client is a Belgian biopharmaceutical company whose main activities consist of performing research, development and commercial launch of pharmaceutical and biotechnology products.
The construction of a Bio-Pilot plant on the Braine-L’Alleud site was initiated with the aim of meeting the company’s strategic and quantitative challenges.
Since 2014, this new building has been used for the production of products intended for phase I and II of clinical trials.
In this context, this client assigned Assystem Care the task of commissioning the plant and particularly verifying all of the GMP (Good Manufacturing Practices) systems following the ASTM E2500 approach.
Management and coordination of plant start-up and testing of all production facilities assigned to clinical trials in compliance with GMP on upstream and downstream processes, using the ASTM E2500 verification guidance:
sqm of total surface
sqm of R&D laboratories surface