Comprehensive systems and controls should be in place across the supply chain and development, considering ICH Q10, Q9 and Q8. But this is not enough. Q-Mindset and Q-Culture is the most important indicator of a company’s ability to deliver products with high quality. It’s about behavior – Not SOPs.
Q is everyone’s accountability. Improvement is everyone’s responsibility. Everyone is accountable to make right decisions. Quality behavior in the DNA of everybody is a competitive advantage.