The threats of intentional adulteration, cargo theft, counterfeiting, illegal diversion, and tampering are a serious problem in our global marketplace; where criminals are profiting by putting unassuming patients at risk. These threats are product integrity and security issues. No pharmaceutical company is isolated from this rising challenge; a challenge that has caught even our world leaders’ attention. Effective incident management of product integrity and security issues equips a company to respond quickly, effectively, and in the interest of patient safety. As an industry, most pharmaceutical companies can attest to having rigorous, standardized processes for handling quality incidents internally. While many pharmaceutical companies already have systems and processes in place to prevent, detect, and respond to product integrity and security issues, the maturity of these systems and processes vary from company to company. The intent of this white paper is to share good practices for the incident management of product integrity and security issues, with the ultimate goal protecting patient safety.
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