Cathy Burgess’ comments at a recent conference on “Redefining the ‘c’ in cGMP” were featured on a PharmTech Talk blog post.
Topics of discussion at the conference included how cutting corners on controls and quality management of pharmaceutical manufacturers’ medicines could end up being quite costly in the long run and how the ongoing wave of serious drug shortages and recalls, together with rising pressure on pharmaceutical companies to cut costs, has elevated concerns about oversight of supply chains and outsourcing arrangements.
“I’m truly amazed when I find that clients don’t have quality agreements with contract manufacturers and just rely on simple check lists of responsibilities,” Burgess said. “These often lack provisions for enforcing quality requirements tailored to the specific company…companies cannot outsource quality compliance.”