Outsourcing quality assurance activities can provide pharmaceutical and biotechnology organisations with access to specialist knowledge, additional capacity and independent oversight.
A quality agreement is not simply a commercial contract with additional quality language. Its purpose is to translate applicable Good Manufacturing Practice, Good Laboratory Practice, Good Clinical Practice, and other relevant quality requirements
Quality, compliance and bureaucracy represent three different concepts that must be carefully balanced within regulated organisations.
Successful organisations build enough internal capability to govern outsourced activities effectively. They understand their regulatory obligations, maintain appropriate oversight, and ensure that external partnerships operate correctly.