A | MOST OFTEN, THE GMP/GDP COMPLIANCE FUNCTION reports into the quality operations (assurance) organization (supporting manufacturing and supply). Within this organization the formal compliance roles can be centralized in a core unit or decentralized across departments. However, it is not uncommon for compliance activity and oversight to be external to operations and report directly to the compliance officer. This structure lends itself to greater visibility into an enterprise compliance model but presents shortcomings if clear cross-functional partnerships are not established. The compliance organization should identify risks, advise on the design and implementation of mitigations and controls, and be involved in establishing effectiveness measures — all while playing a significant role in product quality and long-term business continuity.
JASON URBAN, PH.D. is the head of Celgene’s Business Operational Excellence function.