Avoiding product safety incidents and protecting a drug’s reputation for the duration of its patent life — and possibly longer — is critical to the brand integrity and financial performance of any pharmaceutical manufacturer.
Although all major pharmaceutical companies and their partners have product integrity programs, many are highly segmented, which decreases a manufacturer’s ability to coordinate risk oversight measures.
Jerry Wald and Carol Landsman, Ernst & Young, present an approach to product integrity that relies on a “horizontal” risk management function that is comprehensive and enterprise-wide. In addition to defining the accountability of the team executing this function, they describe the common risks that can occur and be managed at each stage of the product life cycle. Companies that adopt this integrated approach to protecting product integrity can move towards a management style that is anticipatory and proactive.
Download the full article, "Protecting product integrity: an integrated approach" (pdf, 82kb).