TIPS TO STAYING ON TRACK FOR DSCSA PREPAREDNESS
Just because the pharmaceutical industry has gained more time does not mean organizations shouldn’t keep up the pace as they prepare for compliance. Here are some tips to ready your business for the looming regulation.
- UNDERSTAND THE REQUIREMENTS
Familiarize yourself with DSCSA’s interoperability requirements. Dedicate a team to learn more about the requirements and work with compliance experts like OPTEL to guide you.
Review your existing traceability reporting systems to identify areas that need updating or changes to meet DSCSA standards.
- CHOOSE THE RIGHT TRACEABILITY TECH
Implement serialization and traceability solutions that comply with DSCSA’s digital interoperable requirements. Ensure they can integrate with existing systems and accommodate future regulatory changes.
- COLLABORATE WITH PARTNERS
Engage with trading partners to align your traceability initiatives and test interoperability months in advance of the 2024 deadline.
Regularly test your systems and processes for DSCSA compliance. Mock audits can help identify gaps and areas for improvement when you report to the FDA.
Ensure that product identifiers, including serial numbers, lot numbers, and expiration dates, are consistently and accurately captured and stored. Many of OPTEL’s clients notice discrepancies in their data integrity.
- PREPARE FOR FDA VERIFICATIONS
Establish comprehensive methods for verification requests, particularly in scenarios involving suspect or counterfeit products.
- TRAIN YOUR TEAM & STAY UPDATED
Regular training ensures that staff understand the importance of DSCSA compliance and are equipped to handle related tasks effectively. Regulations and industry standards evolve at a rapid-fire pace. Join industry groups, attend relevant webinars, and subscribe to updates from the FDA and other regulatory bodies to stay informed.