Integrating Quality into production to drive cost-effective innovation

As the emphasis of new drug development gravitates away from chemical synthesis towards new, ground-breaking therapies and vaccines, the requirements of manufacturing sites, equipment and processes need to be appropriate for this new environment. For young biotechs, scaling up production brings green-field challenges, while for more established pharma a shift may be required to ensure that facilities are optimised for new ways of working.

Across all of this is the criticality of compliance with Good Manufacturing and Good Distribution Practice (GMP/GDP), and of a fit-for-purpose Quality system. Engineering or redesigning facilities without due consideration of what’s needed, of what may be superfluous, or of how systems and processes will be validated over time, could lead to costly remedial action and delays in getting important and premium new products to market.