Launched back in 2009, the FDA’s Secure Supply Chain Pilot Program (SSCPP) defines a new initiative to prevent misbranded or unapproved pharmaceutical ingredients and end products, including counterfeits, from entering the country, while easing the regulations for trusted products. As a result, the FDA will be able to focus more on companies with high inherent risks and less on those with trusted supply networks, high-quality operations and strong quality control.
Getting Ready for the SSCPP
If the current pilot program will be effective, a permanent, more complex program will be developed and extended to a high number of pharmaceutical companies. However, participation in this program will be dependent on certain compliance criteria. The companies struggling to meet these criteria should opt for appropriate FDA compliance software solutions, such as Dynamics AX. Here is how this software product can help pharmaceutical companies meet the FDA’s requirements.
Condition #1: All applicants must comply with the requirements of the Food, Drug, and Cosmetics Act (FDCA).
The FDCA defines a series of good manufacturing practices along with registration and listing requirements that pharmaceutical manufacturers must follow. Since Dynamics AX understands the unique challenges pharmaceutical companies face, it can be customized and setup to meet a series of standards issued by the FDA. In addition, it facilitates integration and interoperability with various tools, such as electronic signatures, tracking features, audit trails, validation templates, scripts and protocols, proposing easy-to-use FDA regulatory compliance software packages that will enable pharmaceutical manufacturers to handle the FDA validation process easier than before.
Condition #2: All applicants must have a secure supply chain protocol according to the Customs-Trade Partnership Against Terrorism (C-TPAT) program.
Led by U.S. Customs and Border Protection, the C-TPAT program focuses on improving the security of supply chains. To obtain C-TPAT certification, organizations must have a documented protocol for identifying and mitigating potential terrorism risks throughout international supply chains. Regarding this aspect, Dynamics AX can help organizations by allowing them to:
- Control User Identity: While it’s imperative for an organization to permit its employees, partners and customers to access data in real-time, it’s also critical to protect information from ‘indiscrete’ eyes. Dynamics AX makes possible effective management of user identities, without preventing authorized users from accessing critical information. This system can also be used to check user profiles at regular intervals and to enable authentication in client-server environments, which takes data protection a step further.
- Protect Data: With Dynamics AX, organizations can run periodic analyses of database infrastructure. This will allow IT personnel to identify changes made to database tables and track process discrepancies to identify actual and potential security problems.
Condition #3: All participants must have a plan that will allow them to correct problems relating to importing pharmaceutical ingredients/products.
Developed with proactive execution in mind, Dynamics AX supports end-to-end transparency, making possible ingredient/product tracking across the supply chain, back and forth from a particular time/event. In addition, the system can be set to compare ingredient/product characteristics against FDA’s standards, allowing pharmaceutical companies to detect, address, correct and prevent importing issues.
Condition #4: All participants must develop an effective recall and corrective action plan.
Delivering intelligent, powerful, role-based FDA compliance software, Dynamics AX not only provides in-depth insight into business processes to help organizations operate with greater agility, but also enables users to virtually develop a variety of cross-channel scenarios. Pharmaceutical companies can use this ability to create corrective action plans for various ‘what-if’ situations in order to revert potentially unwanted or dangerous effects.
Condition #5: All participants must control pharmaceutical ingredients/end products until they reach the end consumer.
Dynamics AX delivers a reliable FDA SSCPP compliance software solution for managing turnaround and delivery times when dealing with non-confirming products; for linking diagnostic information to appropriate corrective measures; and for tracking problems by type (e.g. long-term, short-term, urgent, etc.). With this solution, pharmaceutical groups will be able to ensure quality within supply chains until products reach the end consumer.
In conclusion, Dynamics AX is a reliable ERP solution organizations can use to comply with the FDA’s SSCPP. The pharmaceutical companies participating in this program will be considered low risk, which may result in expedited processing of their products, without further audit or examination.