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Pharmaceutical companies have evolved over the years to comply with regulations regarding strength and purity of their products. They have established reasonable controls over what occurs within their facilities. However, these actions do not address the need for increased visibility and controls over global vendors who supply the materials that make up the final product. This is the need we address.

There is a need for the industry to move from a system of intermittent audits focused on providing an assessment of the process at a given point in time to a continuous monitoring of a broader set of processes covering the entire supply chain on an ongoing basis.

  • Supply chain vulnerabilities can be exposed at any point in time and this need to be monitored continuously.
  • Proactive measures are necessary to identify economically driven adulteration.
  • Timely communication of risk exposure to all levels of management in a manner that enables effective decision making
  • These needs must be met leveraging risk based approaches consistent with regulatory mandates.
  • Disruption in the supply chain leading to product shortages is another key area of focus.  Product recalls resulting from unmitigated risk introduced into the supply chain by vendors/contract manufacturers (as it happened with Heparin and with Ethylene Glycol) have significant monetary and brand impact on the industry.

Gone are the days when the supply chain constituted of one or two stakeholders. Today, each organization has multiple suppliers for every component and between excipient, API, formulation and packaging, an intricate web of suppliers exist. Companies typically do not have the resources to review and track each and every part of their supply chain.