VRS is critical.... but don't ignore the other (and more significant) verification requirements under DSCSA (Marketing Material)

Under DSCSA all segments of the pharmaceutical supply chain are required to have systems/processes which manage requests for product verifications.   For manufacturer’s all DSCSA provisions related to product verifications are live today, meaning not only are manufacturers responsible for meeting the law, but also that the FDA and other agencies may audit these systems/processes.   Such audits have already resulted in 483s (https://www.rxtrace.com/2018/10/mckessons-dscsa-483-explained.html/).

Much attention has been placed recently on the ability for manufacturers to handle saleable returns verifications in advance of the Nov 2019 deadline for wholesalers. While saleable returns and related solutions (VRS) address direct compliance requirements of DSCSA, it is critical for all segments of the pharma supply chain to recognize that the ability to handle saleable returns verification is only one small piece of DSCSA verification management.

Jennason performed a thorough review of verification requirements under DSCSA and related guidance’s and identified the following:

• There are no less than 6 high level quality and regulatory policies which must be developed and/or integrated into existing SOPs.  These polices must cover critical procedures including the handling of verification requests,  FDA requests for information, suspect and illegitimate product handling and trading partner and FDA notifications
• In total the 6 high level policies must define no less than 25 DSCSA required tasks, data capture points, notifications and record retention activities.
• The overwhelming majority of these required tasks/activities are performed outside of your serialization system.  In most cases, your serialization system will only address the requirement to perform product identifier verifications.
• Many verification requirements have strict timing for when responses must be returned to the requestor- often within 24 to 48 hours.
• Verification requirements impact a broad set of functional teams within an organization including, at a minimum, quality, regulatory, supply chain, manufacturing/distribution operations, R&D/testing and legal.

DSCSA Verification Workflow Map
Blurred for confidentiality. 
Reach out to Jennason for a full review

In response to these complex requirements Jennason developed a suite of offerings to help companies understand their total exposure to DSCSA verifications and ensure proper capabilities are in place.

DSCSA Verifications Workshop-  A half day workshop designed to educate internal teams on the full extent of DSCSA verification requirements.  The workshop also facilitates a gap analysis between current quality/regulatory processes impacted by DSCSA verification requirements and desired future state.  Participants are also given a demonstration of the Jennason DSCSA Verifications Manager.

Jennason DSCSA Verifications Manager.   DSCSA Verifications Manager provides an automated workflow solution which ensures companies are completing all required steps in a DSCSA verification process including

• Managing requests for verification from/for trading partners, FDA and saleable returns.
• Capturing verification results and generating response reports to provide to requestors.
• Managing the required suspect product process including quarantine and product investigation.
• Managing the required illegitimate product process including quarantine, sampling and disposition.
• Automated generation of required FDA forms (3911) and trading partner notifications.
• Automated e-mail reminders to ensure verification responses are provided within the required 24hr time period.
• Reporting dashboard which tracks frequency of verification requests, breakdown of requests by product, lot and other attributes and measuring of on-time verification response performance.

More information can be found at https://www.jennason.com/dvm

Jennason Serialization Test Tool.   Jennason’s industry-leading automated testing solution for L3/L4/L5 serialization systems supports DSCSA product identifier verification testing.  Every serialization system has different parameters by which product identifier verification is performed.   To understand how your system operates its critical to test the product identifier verification process with items in a variety of statuses and locations.  Pharma companies leverage the Serialization Test Tool to simulate common serialization use cases, such as commissioning, aggregating, shipping/receiving and end-of-life (e.g. decommissioning, destroying), generate the corresponding test data and communicate that data to their L3/L4/L5 serialization system.  This enables the rapid testing of your system’s product identifier verification process under any business scenario.

More information can be found at https://www.jennason.com/solutions

Contact Jennason today for more information on these offerings.