WHY OPTEL IS YOUR GO-TO PARTNER

The pharmaceutical and food & beverage industries are continuously evolving due to the demand for more rigorous regulations to safeguard citizens from a wide range of issues, including counterfeit, stolen, contaminated or dangerous products.

Two such landmark regulations that have garnered attention in recent years are the Drug Supply Chain Security Act (DSCSA) for pharmaceutical companies and the Food Safety Modernization Act (FSMA) for food & beverage businesses.

Though these regulations cater to different sectors, the foundational elements are astoundingly similar, and companies like OPTEL, leading the charge in DSCSA compliance, are equally positioned to leverage this common ground for FSMA 204 conformity.

blog_dscsa-and-fsma_shared-fondamental-elements

DSCSA VS. FSMA: A COMPARISON

At their core, both DSCSA and FSMA aim to improve the integrity and safety of their respective supply chains.

The DSCSA, as covered in OPTEL’s extensive insights, lays out steps to build a digital, interoperable system that identifies and traces prescription drugs in the United States. Effective supply chain visibility allows all stakeholders to quickly respond to illicit drug distribution and outbreaks related to drug quality.

THE DSCSA PROTECTS CONSUMERS BY ESTABLISHING ENHANCED STANDARDS TO ENSURE:

  •  The safety of prescription drugs: By requiring stringent tracking and verification procedures, DSCSA ensures that prescription drugs are genuine.
  •  Transparency in the drug supply chains: With a digital interoperable system, the DSCSA allows stakeholders to trace the movement of drugs through the supply chain, ensuring that drugs have come from legitimate sources.
  • Rapid response to threats: The act allows for the swift identification and removal of potentially harmful drugs from the supply chain.

Similarly, the FSMA focuses on ensuring the safety of the U.S. food supply by shifting the attention from merely responding to contamination events to their prevention. As covered in OPTEL’s analysis, Regulation 204 of FSMA emphasizes the need for advanced traceability technologies to facilitate rapid and effective foodborne outbreak responses.

THE FSMA SHIFTS THE FOCUS FROM REACTING TO FOODBORNE ILLNESS OUTBREAKS TO PREVENTING THEM

 

  • Preventing food contamination: FSMA mandates facilities to have preventive control plans that identify potential hazards, specify the steps to minimize or prevent them, and detail monitoring and recording procedures.
  • Ensuring the importation of food products: The act emphasizes the responsibility of importers to verify that their global suppliers are compliant with U.S. safety standards.
  • Enhanced traceability and surveillance: With a focus on technology and data, the FSMA will contribute to ensuring that outbreaks of foodborne illnesses can be quickly identified, sourced, and contained.
  • Mandatory inspections: FSMA increases the frequency of inspections at food production facilities, ensuring consistent adherence to safety standards.
blog_dscsa-and-fsma_two-regulations-with-striking-similarities

SHARED FOUNDATIONAL ELEMENTS BETWEEN THE DSCSA AND FSMA

In essence, both DSCSA and FSMA are designed to provide layers of protection for consumers by enhancing the transparency, safety, and traceability of products in the pharmaceutical and food industries, respectively.

The structural similarities between DSCSA and FSMA become even more evident upon a closer look.

Both regulations underscore the need for end-to-end supply chain traceability. Whether it’s DSCSA’s interoperability requirements or the FSMA’s emphasis on food traceability technologies, they both strongly recommend that companies invest in new supply chain traceability solutions so that they can follow products both upstream and downstream.

The two legislations point to the importance of investing in advanced technological platforms to address the needs of auditors for real-time supply chain reporting. The DSCSA and FSMA have established frameworks for regular and as-needed auditing mechanisms.

The DSCSA and FSMA also find common ground with regard to authorized partnerships. The DSCSA stipulates working with authorized trading partners, ensuring the legitimacy of drugs throughout the supply chain. Likewise, the FSMA requires food manufacturers to completely rethink their supplier relationships and screen each new partner for their adherence to the legislation’s rules.

blog_dscsa-and-fsma_two-regulations-with-striking-similarities

OPTEL: YOUR INDUSTRY-AGNOSTIC EXPERTS IN SUPPLY CHAIN REGULATIONS

 For years, OPTEL has been the number 1 supply chain traceability platform for pharma businesses. Given the parallel between the regulations, OPTEL’s position as a trailblazer in complex, multi-faceted supply chains and DSCSA compliance cements its potential for similar regulations, like the FSMA, in the food & beverage industry.

In a world where safety and transparency have never been more paramount, partnering with leaders who recognize and can navigate the intricacies of industry regulations is crucial. As DSCSA and FSMA continue to shape their respective sectors, OPTEL stands out for its unmatched expertise. For businesses in the food & beverage sector, the choice is clear: leverage OPTEL’s track record in pharmaceuticals to pioneer the future of food safety.

WANT TO LEARN MORE? 

Contact Optel Today

RELATED POST

Pharmacist_Medecine_Computer_1062076043_CARD_350x115

Your Go-to Technology Partner to Meet the DSCSA Deadline and Transform the Pharmaceutical Industry for Future Generations

Your Go-to Technology Partner to Meet the DSCSA Deadline and Transform the Pharmaceutical Industry for Future Generations

 Discover
compliance_pharma_2303192663_CARD_350x115 (1)

The FDA’s DSCSA Deadline Extension: What Does That Mean For Your Business?

On August 25 and before policymakers could bring their concerns up to the United States Congress in September, the Food and Drug Administration (FDA) announced it was granting pharmaceutical manufacturers a temporary reprieve.

 Discover
FSMA compliance

How Upcoming Changes to FSMA Rules Will Elevate the Need for More Advanced Food Traceability Technologies

As a further step in ensuring FSMA compliance, real-time and continuous monitoring, OPTEL’s intelligent supply chain platforms, will be paramount in any robust food safety plan.

 Discover