Life Sciences and Pharmaceuticals: Supply Chain and Distribution Networks

This topic examines track-and-trace capabilities that document product custody changes. Transaction information includes product identifier, transaction date, shipment details, and business entities involved. Electronic exchange replaces paper documentation. Product verification confirms authenticity by validating serial numbers against manufacturer databases. Suspect product investigations occur when packages show signs of tampering or...

This topic examines track-and-trace capabilities that document product custody changes. Transaction information includes product identifier, transaction date, shipment details, and business entities involved. Electronic exchange replaces paper documentation. Product verification confirms authenticity by validating serial numbers against manufacturer databases. Suspect product investigations occur when packages show signs of tampering or lack proper documentation. Illegitimate products are counterfeit, diverted, or stolen. Interoperable systems enable information exchange across trading partners. Track-and-trace platforms provide visibility from manufacturer through dispensing.

This topic examines distribution channels. Wholesale distributors (Big 3: McKesson, AmerisourceBergen, Cardinal Health) represent 90% of US distribution, purchasing from manufacturers and selling to pharmacies/hospitals. Specialty distributors handle high-cost, complex therapies requiring special handling and patient support services. Direct delivery ships from manufacturer to pharmacy/hospital, bypassing wholesalers. Retail pharmacies (CVS,...

This topic examines distribution channels. Wholesale distributors (Big 3: McKesson, AmerisourceBergen, Cardinal Health) represent 90% of US distribution, purchasing from manufacturers and selling to pharmacies/hospitals. Specialty distributors handle high-cost, complex therapies requiring special handling and patient support services. Direct delivery ships from manufacturer to pharmacy/hospital, bypassing wholesalers. Retail pharmacies (CVS, Walgreens, independents) dispense to patients. Hospital pharmacies serve inpatients and clinics. Mail order/home delivery serves chronic patients. IT systems manage orders, inventory, invoicing, and chargeback processing across channels.

This topic covers inventory management specific to pharmaceuticals. Safety stock buffers against demand variability and supply disruptions. Reorder points trigger replenishment orders. Expiry management uses first-expiry-first-out (FEFO) to minimize waste. Demand forecasting combines historical sales, market trends, seasonality, and planned promotional activities. Inventory optimization balances service levels (avoiding stockouts) against...

This topic covers inventory management specific to pharmaceuticals. Safety stock buffers against demand variability and supply disruptions. Reorder points trigger replenishment orders. Expiry management uses first-expiry-first-out (FEFO) to minimize waste. Demand forecasting combines historical sales, market trends, seasonality, and planned promotional activities. Inventory optimization balances service levels (avoiding stockouts) against carrying costs and expiry risk. Shortage management prioritizes allocation during supply constraints. Enterprise systems provide inventory visibility across manufacturing sites, distribution centers, and channel partners.

This topic examines counterfeit drug prevention. Counterfeit medicines pose serious patient safety risks. Authentication technologies include: overt features (holograms, color-shifting inks visible to naked eye), covert features (UV inks, taggants requiring special equipment), and forensic features (molecular markers). Serialization with unique identifiers enables verification against manufacturer databases. RFID tags provide...

This topic examines counterfeit drug prevention. Counterfeit medicines pose serious patient safety risks. Authentication technologies include: overt features (holograms, color-shifting inks visible to naked eye), covert features (UV inks, taggants requiring special equipment), and forensic features (molecular markers). Serialization with unique identifiers enables verification against manufacturer databases. RFID tags provide additional tracking. Verification occurs at multiple points: manufacturing, wholesale receiving, pharmacy dispensing. Tamper-evident packaging shows if products were opened. IT systems enable real-time verification, suspicious product flagging, and investigation workflows.

This topic covers supply chain visibility platforms that provide real-time insight into product location, condition, and status. IoT sensors monitor temperature, humidity, shock, and light exposure during transit. GPS tracking shows shipment locations. Blockchain provides immutable records of custody changes and product provenance. Control tower dashboards aggregate data from multiple...

This topic covers supply chain visibility platforms that provide real-time insight into product location, condition, and status. IoT sensors monitor temperature, humidity, shock, and light exposure during transit. GPS tracking shows shipment locations. Blockchain provides immutable records of custody changes and product provenance. Control tower dashboards aggregate data from multiple sources providing end-to-end visibility. Alerts notify stakeholders of exceptions (temperature excursions, delayed shipments, inventory shortages). Transparency requirements include sharing data with regulators, trading partners, and increasingly, patients. Cloud-based visibility platforms enable multi-enterprise collaboration.

This topic covers supply chain risk management. Risks include: supplier failures, natural disasters, geopolitical disruptions, quality issues, and demand spikes. Risk identification assesses vulnerabilities across the supply network. Supplier qualification evaluates capabilities and compliance. Dual sourcing maintains multiple suppliers for critical materials. Safety stock buffers against disruptions. Contingency plans define...

This topic covers supply chain risk management. Risks include: supplier failures, natural disasters, geopolitical disruptions, quality issues, and demand spikes. Risk identification assesses vulnerabilities across the supply network. Supplier qualification evaluates capabilities and compliance. Dual sourcing maintains multiple suppliers for critical materials. Safety stock buffers against disruptions. Contingency plans define response procedures for shortage scenarios. Business continuity planning ensures critical product availability during disruptions. Regulatory agencies require shortage notifications and mitigation plans. Supply chain risk management platforms identify, assess, and monitor risks while enabling scenario planning.

This topic provides an overview of the pharmaceutical supply chain. The chain begins with API manufacturers (often in India, China) who produce active ingredients. Drug manufacturers receive APIs and excipients to produce finished dosage forms. Wholesalers (McKesson, AmerisourceBergen, Cardinal Health) purchase products and distribute to pharmacies, hospitals, and clinics. Specialty...

This topic provides an overview of the pharmaceutical supply chain. The chain begins with API manufacturers (often in India, China) who produce active ingredients. Drug manufacturers receive APIs and excipients to produce finished dosage forms. Wholesalers (McKesson, AmerisourceBergen, Cardinal Health) purchase products and distribute to pharmacies, hospitals, and clinics. Specialty distributors handle complex products requiring special handling. Pharmacies dispense to patients. Each handoff requires documentation and verification. IT systems must track products, transactions, and custody changes throughout the supply chain.

This topic covers serialization regulations that assign unique identifiers to each package and case. DSCSA (US) requires product identifiers including National Drug Code (NDC), serial number, lot number, and expiration date encoded in 2D barcodes. Full implementation achieved November 2024 requires enhanced drug distribution security. EU FMD requires unique identifiers...

This topic covers serialization regulations that assign unique identifiers to each package and case. DSCSA (US) requires product identifiers including National Drug Code (NDC), serial number, lot number, and expiration date encoded in 2D barcodes. Full implementation achieved November 2024 requires enhanced drug distribution security. EU FMD requires unique identifiers and anti-tampering devices on prescription medicines. Serialization enables product authentication, recall management, and counterfeit prevention. IT systems must generate serial numbers, print barcodes, aggregate packages to cases, and report data to regulatory repositories.

This topic covers cold chain management for biologics, vaccines, and other temperature-sensitive products. Storage requirements range from refrigerated (2-8°C) to frozen (-20°C) to ultra-cold (-80°C for some vaccines). Temperature monitoring uses data loggers and real-time sensors. Qualified shipping containers (passive with ice packs or active with refrigeration) maintain temperature during...

This topic covers cold chain management for biologics, vaccines, and other temperature-sensitive products. Storage requirements range from refrigerated (2-8°C) to frozen (-20°C) to ultra-cold (-80°C for some vaccines). Temperature monitoring uses data loggers and real-time sensors. Qualified shipping containers (passive with ice packs or active with refrigeration) maintain temperature during transit. Storage equipment (refrigerators, freezers) requires qualification (IQ/OQ/PQ). Temperature excursions trigger investigations and stability assessments. IT systems integrate temperature sensors, provide real-time alerts, document excursions, and maintain compliance records.

This topic examines global supply chain operations. Import/export regulations vary by country, requiring licenses and regulatory approvals. Customs documentation includes commercial invoices, packing lists, and certificates of analysis. Good Distribution Practice (GDP) guidelines ensure quality throughout storage and transportation. International shipping requires specialized carriers with pharma handling capabilities. Regulations cover...

This topic examines global supply chain operations. Import/export regulations vary by country, requiring licenses and regulatory approvals. Customs documentation includes commercial invoices, packing lists, and certificates of analysis. Good Distribution Practice (GDP) guidelines ensure quality throughout storage and transportation. International shipping requires specialized carriers with pharma handling capabilities. Regulations cover drug importation restrictions, controlled substance tracking, and parallel trade in EU. Transfer pricing affects cross-border transactions between affiliates. Global trade management systems handle documentation, compliance, and customs clearance.