According to recent FDA updates on the implementation of the Safety and Innovation Act (FDASIA), nearly 40 percent of finished drugs are being imported, and nearly 80 percent of active ingredients, excipients, and components used to manufacture drugs are sourced from international suppliers. To control the risks associated with increased globalization and supply chain security issues, FDASIA requires that US registered drug manufacturers include the name, address, and unique facility identifiers (UFIs) of associated excipient manufacturers as part of each drug listing. In addition, the Act clarifies that cGMP encompasses oversight and control over the manufacture of drugs to ensure quality, including managing the risk of and establishing the safety of ingredients, raw materials used in manufacturing, and finished drug products.
The reality of the risks associated with this globalization of the drug manufacturing supply chain - as well as the subsequent FDA enforcement of FDASIA - is now forcing manufacturers to build and manage robust and risk-based supplier management programs. But implementing and maintaining a successful supplier management program can be quite daunting, especially when a firm has limited knowledge of the areas that suppliers typically struggle with. So what steps should manufacturers take to detect and control supplier issues before commencing the manufacturing process?
It is critical that your quality unit continually evaluates the qualification status of suppliers to ensure their suitability and competence. In the event of adverse information, supplier disqualification may be necessary.
By implementing and managing a robust and risk-based supplier management program, your firm can be assured that your extension into the supply chain will detect and control any issues before they enter your manufacturing process.
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