• Advertise
  • Contact Us
  • About Us
  • Supplier Directory
  • SCB YouTube
  • Login
  • Subscribe
  • Logout
  • My Profile

  • CORONAVIRUS
  • LOGISTICS
    • Air Cargo
    • All Logistics
    • Express/Small Shipments
    • Facility Location Planning
    • Freight Forwarding/Customs Brokerage
    • Global Gateways
    • Global Logistics
    • Last Mile Delivery
    • Logistics Outsourcing
    • LTL/Truckload Services
    • Ocean Transportation
    • Rail & Intermodal
    • Reverse Logistics
    • Service Parts Management
    • Transportation & Distribution
  • TECHNOLOGY
    • All Technology
    • Artificial Intelligence
    • Cloud & On-Demand Systems
    • Data Management (Big Data/IoT/Blockchain)
    • ERP & Enterprise Systems
    • Forecasting & Demand Planning
    • Global Trade Management
    • Inventory Planning/ Optimization
    • Product Lifecycle Management
    • Sales & Operations Planning
    • SC Finance & Revenue Management
    • SC Planning & Optimization
    • Sourcing/Procurement/SRM
    • Supply Chain Visibility
    • Transportation Management
  • GENERAL SCM
    • Business Strategy Alignment
    • Education & Professional Development
    • Global Supply Chain Management
    • Global Trade & Economics
    • HR & Labor Management
    • Quality & Metrics
    • Regulation & Compliance
    • SC Security & Risk Mgmt
    • Supply Chains in Crisis
    • Sustainability & Corporate Social Responsibility
  • WAREHOUSING
    • All Warehouse Services
    • Conveyors & Sortation
    • Lift Trucks & AGVs
    • Order Fulfillment
    • Packaging
    • RFID, Barcode, Mobility & Voice
    • Robotics
    • Warehouse Management Systems
  • INDUSTRIES
    • Aerospace & Defense
    • Apparel
    • Automotive
    • Chemicals & Energy
    • Consumer Packaged Goods
    • E-Commerce/Omni-Channel
    • Food & Beverage
    • Healthcare
    • High-Tech/Electronics
    • Industrial Manufacturing
    • Pharmaceutical/Biotech
    • Retail
  • REGIONS
    • Asia Pacific
    • Canada
    • China
    • Europe
    • Latin America
    • Middle East/Africa
    • North America
  • THINK TANK
  • WEBINARS
    • On-Demand Webinars
    • Upcoming Webinars
  • PODCASTS
  • VIDEOS
  • WHITEPAPERS
Home » Track and Trace in Pharma Manufacturing Boosts Compliance Goals
ANALYSIS

Track and Trace in Pharma Manufacturing Boosts Compliance Goals

February 8, 2020
Gary Neights, SCB Contributor
Analyst Insight: To address changing patient and market needs, pharmaceutical companies are expanding their product portfolios to include specialized and even individualized drugs. Precise, real-time control is indispensable to avoiding quality issues during the production or shipment of these smaller-batch items. To support this growing trend, systems of the extended supply chain need to be integrated to provide synchronization and process visibility.

As more and more of the supply chain falls outside of the direct administration of the pharmaceutical manufacturer, digitization of supply-chain processes is key to maintaining control and visibility. More importantly, digitization is required to help meet government regulations on the tracking and tracing of materials, from raw-material suppliers to end customers. A multi-channel network that extends control and visibility beyond the four walls of the business to all partners, including material suppliers, manufacturers, packagers, and transporters, allows everyone on the network to see relevant information, so they can better manage their component of the supply chain.

The Drug Supply Chain Security Act mandates that manufacturers and distributors of pharmaceuticals in the U.S. must fully comply with new traceability regulations by 2023. In the event of a recall of a drug or its component, companies will need the ability to identify every place in the supply chain where the problem product exists, whether in storage, a manufacturing facility, on a truck or in a distribution center. The key to this granular level of traceability is visibility across an extended supply chain, which gathers information from all connected shareholders.

In order to track and trace from raw-material suppliers through to the end patient, drug manufacturers need data structures that support batch numbers, lot numbers, serial numbers, packaging levels and quality information, across both raw materials and finished goods. Ideally, a finished-good certificate of analysis (COA) will reflect the quality characteristics of the product and its components. This should include all details (such as manufacturing, movements, operations and quality) of raw materials and finished goods as they move through the supply chain and are ultimately consumed.

Today’s pharmaceutical companies often rely upon contract manufacturers to maximize flexible, high-quality production at the lowest possible cost. With the trend toward production of more specialized, smaller batches of medicines, the systems of the extended supply chain need to be integrated to provide synchronization and process visibility. Data flowing from these systems needs to be orchestrated, including raw material and packaging orders; contract manufacturing orders; raw, intermediate and finished goods movements; transportation orders and status; shipment status, and receipt of goods.

Outlook:

In the future, pharmaceutical manufacturing will be more automated and flexible, with better intelligence about the quality of goods. Manufacturers will be able to provide surgical insight into each pill in a blister pack, and understand every detail in its lineage. Track-and-trace and quality-management solutions will become embedded in the everyday workings of pharmaceutical manufacturers, making it easier to solve counterfeit drug challenges, and to save lives.

Gary Neights is Senior Director of Product Management with Elemica.

RELATED CONTENT

RELATED VIDEOS

Pharmaceutical/Biotech
KEYWORDS Pharmaceutical/Bio-Tech
  • Related Articles

    Pharma Industry Takes the Lead on Track-and-Trace Compliance

    Cognex Debuts In-Sight Track & Trace for Pharma

Gary Neights, SCB Contributor

More from this author

Wake up to live
“Supply Chains in Crisis”
updates and the latest Supply Chain News!

Subscribe to our Daily Newsletter

Timely, incisive articles delivered directly to your inbox.

Popular Stories

  • silicon wafer

    Fate of U.S. Chipmaking Looks More Like Fantasy

    Technology
  • Warehouse worker

    Why Higher Wages Alone Won’t Solve the Supply Chain Labor Shortage

    Warehousing
  • Mobile App

    Podcast | Companies Are on a Shopping Spree for Supply Chain Software

    Technology
  • Adidas

    From Sneakers to Teslas, China Lockdowns Upend Global Supply Chains

    Coronavirus
  • gas

    Supply Worries Send Gasoline Prices to Record Highs

    Global Supply Chain Management

Digital Edition

Scb feb 2022 sm

2022 Supply Chain Management Resource Guide

VIEW THE LATEST ISSUE

Case Studies

  • 3PL Doubles Productivity With Robots to Fulfill Medical Supply Orders

  • E-Commerce Company Cuts Order Fulfillment Time by 40%

  • Fashion Retailer Halves Fulfillment Time With Omichannel Automation

  • Distributor Scales Business by Integrating Warehouse Automaton Software

  • Fast-Growing Fashion Brand Scales E-Commerce Fulfillment With Whiplash

Visit Our Sponsors

Yang Ming Alithya Barcoding
Blue Yonder BNSF Logistics Generix
GEP GIB USA GreyOrange
Here Honeywell Intelligrated Inmar
Keelvar Kinaxis Korber
Liberty SBF Locus Robotics Lucas Systems
Nvidia Old Dominion Parsyl
Redwood Logistics Saddle Creek Logistics Schneider Dedicated
Setlog Holding AG Ship4WD Shipwell
Tecsys TGW Systems Thomson Reuters
Tive Trailer Bridge Vecna Robotics
Whiplash    
  • More From SCB
    • Featured Content
    • Video Library
    • Think Tank Blog
    • SupplyChainBrain Podcast
    • Whitepapers
    • On-Demand Webinars
    • Upcoming Webinars
  • Digital Offerings
    • Digital Issue
    • Subscribe
    • Manage Your Subscription
    • Newsletters
  • Resources
    • Events Calendar
    • SCB's Great Supply Chain Partners
    • Supplier Directory
    • Case Study Showcase
    • Supply Chain Innovation Awards
    • 100 Great Partners Form
  • SCB Corporate
    • Advertise on SCB.COM
    • About Us
    • Privacy Policy
    • Contact Us
    • Data Sharing Opt-Out

All content copyright ©2022 Keller International Publishing Corp All rights reserved. No reproduction, transmission or display is permitted without the written permissions of Keller International Publishing Corp

Design, CMS, Hosting & Web Development :: ePublishing