1. What is regulatory compliance in the context of traceability?

Regulatory compliance refers to adhering to laws, regulations, and industry standards that require organizations to track and document the production, distribution, and movement of goods. Traceability ensures that businesses can provide accurate records of their products, meeting legal and safety requirements. 

2. Why is traceability important for regulatory compliance?

Traceability helps businesses comply with safety, quality, and legal requirements by enabling quick identification of products in case of recalls, audits, or quality checks. It ensures transparency, reduces risks, and enhances consumer trust. 

3. Which industries require traceability for compliance?

Industries that commonly require traceability include: 

• Healthcare & Pharmaceuticals (e.g., tracking drugs and medical devices under NAFDAC Traceability  regulations) 

4. What are some key regulations that require traceability?

NAFDAC and some other global traceability regulations include: 

• NAFDAC Traceability Regulations See Link NIGERIA PHARMACEUTICAL TRACEABILITY REGULATIONS 

• UDI (Unique Device Identification) for Medical Devices – USA & EU 

• Pharmaceutical Serialization Laws (e.g., DSCSA in the USA, FMD in the EU) 

• ISO 9001 & ISO 22005 for quality management and food traceability 

5. How does GS1 Standards help in traceability compliance?

GS1 Standards provide globally recognized identification and data-sharing systems, including barcodes, RFID, and EPCIS. These help businesses meet regulatory requirements by ensuring accurate product identification and real-time traceability across supply chains. 

6. What are the benefits of implementing a traceability system for compliance?

• Improved product safety (quick recall management) 

• Better supply chain visibility (real-time tracking) 
• • Enhanced regulatory reporting (audit readiness) 
  • Increased efficiency (reduced errors and operational costs) 
  • Stronger consumer trust (proven product authenticity) 
  7. What are common challenges in achieving regulatory traceability compliance?
  • Data management complexity (handling vast amounts of traceability data) 
  • Interoperability issues (ensuring different systems work together) 
  • Cost of implementation (investing in traceability technology) 
  • Regulatory updates (staying compliant with evolving laws) 
  8. How can businesses ensure compliance with traceability regulations?
  • Obtain basic training about GS1 standards and traceability from GS1 Nigeria 
  • Implement GS1 Standards for standardized identification of products and locations: Global Trade Item Number, Serial Shipping Container Code and Global Location Number for Trade items, Logistic items and physical locations respectively. These identification keys will also require that you provide master data(Item description) when allocating the GTIN and GLN. 
  • Use automated tracking systems (2D Datamatrix barcode for trace items and GS1 128 Barcode for logistics items) 
  • Obtain the support of GS1 Nigeria accredited traceability and hardware solution providers that will help you share traceability events for your products 
  • Maintain comprehensive documentation (batch records, supplier data) 
  • Conduct regular audits and training for employees 
  • Stay informed about changing regulations 
  9. Does NAFDAC specify certain master data requirements 
  • NAFDAC specifies the following requirements for product master data: See link: https://www.nafdac.gov.ng/wp-content/uploads/Files/Resources/Traceability/Control-Copy-Guidance-on-Master-Data-Attributes-for-Pharmaceutical-Products-DGO-GDL-001-00-1.pdf 
  • NAFDAC specifies the following for location master data 

  GLN Listing Master Data Requirement for GS1 Nigeria Healthcare Members 

  • Country 
  • • State 
    • Local Government Area 
    • Address 
    • City 
    • Longitude 
    • Latitude 
    • Postal Code 
    • Nearest Bus stop 
    • Landmark 
    • Opening Days 
    • Affiliation