• Login
    • Join
  • FOLLOW:
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Opinions
    • Top 30
    • Research
    • Supply Chain
    • Device Sectors
    • Directory
    • Events
    • Resources
    • Microsites
    • More
  • Magazine
  • News
  • Opinions
  • Top 30
  • Research
  • Supply Chain
  • Device Sectors
  • Directory
  • Events
  • Resources
  • Microsites
  • Current / Back Issues
    Features
    Editorial
    Digital Edition
    eNewsletter Archive
    Our Team
    Editorial Guidelines
    Reprints
    Subscribe Now
    Advertise Now
    Top Features
    Cybersecurity Challenges Leave Medical Device Makers Insecure

    OEMs Are Demanding Designs that Challenge Suppliers

    Diabetes Technology Manufacturers Seemingly on a Sugar Rush

    Post-Pandemic Partnerships: A Full-Service Outsourcing Discussion

    Discovering the Value of Surface Treatments and Coatings for Medtech
    OEM News
    Supplier News
    Service / Press Releases
    Online Exclusives
    Press Releases
    People in the News
    Product & Service Releases
    Supplier News
    Medtech Makers
    Technical Features
    International News
    Videos
    Product & Service Releases
    Live From Shows
    Regulatory
    Financial/Business
    Top News
    Medtronic, DaVita to Create New Kidney Care Firm

    OmniGuide's RevoLix HTL Hybrid Thulium Laser OK'ed for BPH and Stone Treatments

    In Vitro Diagnostic Medical Devices Regulation Takes Effect

    Brian Case Appointed Chief Technology Officer at KORU Medical

    Solid Growth Expected for India's Medical Device Sector
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Cybersecurity Challenges Leave Medical Device Makers Insecure

    OEMs Are Demanding Designs that Challenge Suppliers

    Diabetes Technology Manufacturers Seemingly on a Sugar Rush

    Post-Pandemic Partnerships: A Full-Service Outsourcing Discussion

    Discovering the Value of Surface Treatments and Coatings for Medtech
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Injecting Neurostimulators into Blood Vessels (We Swear, It’s Not Sci-Fi)

    Understanding the Costs of Care in the OR

    Sick of Being Sick: Pandemic Fatigue Flares at AAOS

    Managing Critical Healthcare Supply Chains in Turbulent Times

    To Drive Value, Human Capital Leaders Turn to Outsourced Solutions
    3D/Additive Manufacturing
    Contract Manufacturing
    Electronics
    Machining & Laser Processing
    Materials
    Molding
    Packaging & Sterilization
    R&D & Design
    Software & IT
    Testing
    Tubing & Extrusion
    Cardiovascular
    Diagnostics
    Digital Health
    Neurological
    Patient Monitoring
    Surgical
    Orthopedics
    All Companies
    Categories
    Company Capabilities
    Add New Company
    Outsourcing Directory
    Arthur G. Russell Co. Inc., The

    Fusion Biotec Inc.

    Xact Wire EDM Corp.

    Cirtec Medical

    Concise Engineering
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    3D Printing in Dental Prosthodontics, Orthodontics, and Surgery

    What New Tech Can Improve Your Medical Manufacturing Plant?

    Why Medical Device Firms Must Navigate the Muddy Waters of ESG Requirements

    Medical Device Servicing vs. Remanufacturing

    Digital Marketplaces for Medical Equipment Come of Age
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Arthur G. Russell Co. Inc., The

    Fusion Biotec Inc.

    Xact Wire EDM Corp.

    Cirtec Medical

    Concise Engineering
    • Magazine
      • Current/Back Issues
      • Features
      • Editorial
      • Columns
      • Digital Editions
      • Subscribe Now
      • Advertise Now
    • News
    • Directory
      • All Companies
      • ALL CATEGORIES
      • Industry Associations
      • Company Capabilities
      • Add Your Company
    • Supply Chain
      • 3D/Additive Manufacturing
      • Contract Manufacturing
      • Electronics
      • Machining & Laser Processing
      • Materials
      • Molding
      • Packaging & Sterilization
      • R&D & Design
      • Software & IT
      • Testing
      • Tubing & Extrusion
    • Device Sectors
      • Cardiovascular
      • Diagnostics
      • Digital Health
      • Neurological
      • Patient Monitoring
      • Surgical
      • Orthopedics
    • Top 30 Company Report
    • Expert Insights
    • Slideshows
    • Videos
    • eBook
    • Resources
    • Podcasts
    • Infographics
    • Whitepapers
    • Research
      • White Papers
      • Case Studies
      • Product Spec Sheets
      • Market Data
    • MPO Summit
    • Events
      • Industry Events
      • Live From Show Events
      • Webinars
    • Microsite
      • Companies
      • Product Releases
      • Product Spec Sheets
      • Services
      • White Papers / Tech Papers
      • Press Releases
      • Videos
      • Literature / Brochures
      • Case Studies
    • About Us
      • About Us
      • Contact Us
      • Advertise with Us
      • eNewsletter Archive
      • Privacy Policy
      • Terms of Use
    Online Exclusives

    Maintaining Quality in the Fast-Paced Contract Manufacturing Industry

    A cautionary tale from pharma offers lessons to device manufacturers about the dangers of a quality system that isn’t digital.

    Maintaining Quality in the Fast-Paced Contract Manufacturing Industry
    Related CONTENT
    • BMP Medical - Delivering Custom Plastics Manufactured Solutions
    • C&J Industries Inc.
    • Teleflex Medical OEM
    • Oberg Medical
    • LRE Medical GmbH
    Dale Thompson, Staff Writer, MasterControl 05.27.21
    Contract manufacturing and contract development manufacturing organizations (CMOs and CDMOs) remain in the spotlight for helping to make it possible to produce COVID-19 vaccines, which are needed around the world. As of mid-May, about 9.7 percent of the world’s population has been vaccinated against COVID-19, which equates to 1.48 billion doses.1 With all eyes on the contract manufacturing industry, increased scrutiny brings the issue of maintaining quality to the forefront.
     
    It’s a significant challenge to manufacture a product at the quick pace demanded by customers while maintaining impeccable quality. Managing multiple, changing product lines increases complexity and the difficulty of maintaining speed as well as quality. With a modern manufacturing solution, CMOs and CDMOs can prioritize both.
     
    Costs of Compromising Quality
    Emergent BioSolutions was rushing to manufacture vaccines for Johnson & Johnson and AstraZeneca at their plant based in Maryland, and a production error led the CDMO to scrap the materials for up to 15 million Johnson & Johnson vaccine doses.2 In April 2020, the U.S. Food and Drug Administration (FDA) issued a Form 483, which noted several quality control issues at Emergent’s manufacturing site that led to the cross contamination of materials including a lack of written procedures and inadequate operator training.3
     
    Now the FDA is questioning whether or not the equivalent of 70 million doses from the same plant can be distributed, and executives from Emergent BioSolutions will testify before the House Select Subcommittee on the Coronavirus.4,5
     
    No CMO or CDMO wants to find themselves in a similar position. In the race to keep up with demand, losing sight of quality can jeopardize compliance. More importantly, it can result in longer wait times for people who need life-saving products.
     
    Improve Quality with Digitization
    The likelihood of encountering problems like those experienced by Emergent BioSolutions (i.e., lack of written procedures and inadequate training) can be greatly reduced with a fully integrated, digital platform where standard operating procedures (SOPs), training documents, and production records can be managed from a central location. By operating from a connected system, it is possible to embed quality into every stage of production.
     
    The National Institute of Standards and Technology reported that investing in advanced technology delivers benefits such as:
     
    • Increased operational efficiency and agility
    • Reduced downtime
    • Improved ability to predict and adjust to facility and supply changes6
     
    Customers who digitized with MasterControl’s platform solution can attest to the significant quality improvements that are possible through digitization:
     
    • A contract manufacturer reduced shop floor data input errors and data integrity issues by 90 percent.
    • The improvements made by the contract manufacturer mentioned above helped shorten the quality review period from 10 to 15 days after production completes to a mere three days—a 75 to 80 percent reduction.
    • A contract packager reduced total deviations related to data integrity issues by 25 to 30 percent.
    • A contract development and 503B facility is working toward eliminating 90 to 100 percent of data entry errors, and they plan to accelerate incident resolution by moving from a paper to digital solution.
     
    Digitization streamlines quality and compliance, and the results are tangible. By putting off digital transformation, organizations are doing so at the cost of quality.
     
    The Time to Digitize is Now
    For CMOs and CDMOs, quality is a competitive differentiator, and it’s important to stay ahead so you don’t risk falling behind—the time to digitize is now.
     
    Emeritus Professor for the London School of Economics, Leslie Willcocks conducted research on digital transformation and found that once a company falls behind, there may not be a way to recover.
     
    “Our evidence, consistent with other studies, shows that being slow to adopt digital technologies may reduce risk in the short term, in terms of cost, talent, and time, but it builds growing business risk and diminished competitiveness in the long term. This trend will be repeated and magnified by the growing adoption of emerging technologies, such as automation and AI over the next five years. Put bluntly, the competitive advantage of ‘leader’ firms could become irreversible,” she reported.7
     
    For as ominous as that sounds, this presents an opportunity to digitize today and gain a considerable edge over competitors, but the timing is critical. No CMO or CDMO can afford to be playing catch up, especially when it could be a losing battle and a focus on quality is a winning strategy.
     
    References
    1 More Than 1.48 Billion Shots Given: Covid-19 Tracker, Bloomberg, May 18, 2021.
    2 Emergent’s Baltimore plant flagged for quality control concerns last April, FDA report reveals, Fraiser Kansteiner, Fierce Pharma, April 9, 2021.
    3 Form 483 for Emergent Manufacturing Operations Baltimore, LLC, Food and Drug Administration, April 2021.
    4 Baltimore Vaccine Plant’s Troubles Ripple Across 3 Continents, Chris Hamby, Sharon LaFraniere, and Sheryl Gay Stolberg, The New York Times, May 12, 2021.
    5 Emergent BioSolutions CEO, founder head for the Hill as Congress probes production contracts, errors, Fraier Kansteiner, Fierce Pharma, May, 12, 2021.
    6 7 Manufacturing Digitization Challenges – and How to Overcome Them, Celia Paulson, National Institute of Standards and Technology, June 25, 2020.
    7 How to Succeed At Digital Transformation, Leslie Willcocks, Forbes, January 29, 2021.
     

    Dale Thompson is a content marketing specialist at MasterControl’s headquarters in Salt Lake City, Utah. Her areas of expertise are pharmaceuticals and manufacturing. Thompson’s varied career includes extensive work in grant writing and journalism as well as crafting content to highlight the work of biology professors and paleontologists. She has a bachelor’s degree from Evergreen State College and a master’s degree in professional communication from Westminster College.
    Related Searches
    • Contract Manufacturing
    Related Knowledge Center
    • Contract Manufacturing
    Suggested For You
    BMP Medical - Delivering Custom Plastics Manufactured Solutions BMP Medical - Delivering Custom Plastics Manufactured Solutions
    C&J Industries Inc. C&J Industries Inc.
    Teleflex Medical OEM Teleflex Medical OEM
    Oberg Medical Oberg Medical
    LRE Medical GmbH LRE Medical GmbH
    Simbex Simbex
    SigmaTron International SigmaTron International
    3DT LLC 3DT LLC
    High Tech Turning Co. Inc. High Tech Turning Co. Inc.
    Dupaco Inc. Dupaco Inc.
    Nissha Medical Technologies Nissha Medical Technologies
    Northeast Biomedical, Inc. Northeast Biomedical, Inc.
    sfm medical devices GmbH sfm medical devices GmbH
    Coastline International Inc. Coastline International Inc.
    NDH Medical Inc. NDH Medical Inc.

    Related Content

    • BMP Medical - Delivering Custom Plastics Manufactured Solutions

      BMP Medical - Delivering Custom Plastics Manufactured Solutions

      Medical Contract Manufacturing, Design, Assembly & Packaging

    • C&J Industries Inc.

      C&J Industries Inc.

      ...
      Christa Schreckengost, Marketing Coordinator 12.02.21

    • Teleflex Medical OEM

      Teleflex Medical OEM

      Teleflex Medical OEM is a global business dedicated to transforming ideas into market-ready products.
      Krista Ray, Manager of Global Marketing Communications - OEM 11.30.21


    • Oberg Medical

      Oberg Medical

      ...
      Ken Eck, Marketing Communications Manager 11.17.21

    • LRE Medical GmbH

      ...
      Claudia, Strehle 11.16.21


      Trending
      • Dexcom Reportedly In Talks To Acquire Insulet | Medical Product Outsourcing
      • Shrinking Medical Devices Create Sizable Challenges For Micromolders | Medical Product Outsourcing
      • 5 Ways Plastics Revolutionized The Healthcare Industry | Medical Product Outsourcing
      • Anumana's ECG Pulmonary Hypertension AI Algorithm Gains Breakthrough Status | Medical Product Outsourcing
      • Prometheus Group Sued Over Reused Catheters And Rectal Sensors | Medical Product Outsourcing
      Breaking News
      • Medtronic, DaVita to Create New Kidney Care Firm
      • OmniGuide's RevoLix HTL Hybrid Thulium Laser OK'ed for BPH and Stone Treatments
      • In Vitro Diagnostic Medical Devices Regulation Takes Effect
      • Brian Case Appointed Chief Technology Officer at KORU Medical
      • Solid Growth Expected for India's Medical Device Sector
      View Breaking News >
      CURRENT ISSUE

      May 2022

      • Cybersecurity Challenges Leave Medical Device Makers Insecure
      • Contract Design for Medtech
      • Diabetes Medical Device Technology Update
      • Medtech Full-Service Outsourcing Q&A 2022

      Cookies help us to provide you with an excellent service. By using our website, you declare yourself in agreement with our use of cookies.
      You can obtain detailed information about the use of cookies on our website by clicking on "More information”.

      • About Us
      • Privacy Policy
      • Terms And Conditions
      • Contact Us

      follow us

      Subscribe
      Nutraceuticals World

      Latest Breaking News From Nutraceuticals World

      Thorne Relaunches Gut Health Test with Microbiome Wipe
      Alkemist Labs Announces Alkemist Assured Seal and Next Generation Transparency Reports
      GC Rieber Foundations Expand Philanthropic Efforts
      Coatings World

      Latest Breaking News From Coatings World

      ICP Receives ASC Innovation Award for Spray Foam That Meets Changing Environmental Regulations
      Pylon Coatings Uses Polygiene Biomaster & Verimaster for Antimicrobial Surface Protection
      Sto Corp. Recognized with Multiple Honors at the EIFS Hero Awards
      Medical Product Outsourcing

      Latest Breaking News From Medical Product Outsourcing

      Medtronic, DaVita to Create New Kidney Care Firm
      OmniGuide's RevoLix HTL Hybrid Thulium Laser OK'ed for BPH and Stone Treatments
      In Vitro Diagnostic Medical Devices Regulation Takes Effect
      Contract Pharma

      Latest Breaking News From Contract Pharma

      DFE Pharma Opens India CoE for Fast-Track Formulation Services
      Helsinn Establishes New R&D Hub in the U.S.
      CureVac, myNEO Partner on Antigen Targets for mRNA-Cancer Vax Development
      Beauty Packaging

      Latest Breaking News From Beauty Packaging

      Carlyle To Acquire HCP Packaging
      Estée Lauder Companies Faces Class Action Lawsuit
      La Roche-Posay Launches Matte Moisturizer for Oily Skin
      Happi

      Latest Breaking News From Happi

      Women in Flavor and Fragrance Present 2022 Recognition Awards Dinner June 16
      Univar Expands Distribution Agreement with ANGUS Chemical Company
      Acme-Hardesty Passes Responsible Distribution Verification
      Ink World

      Latest Breaking News From Ink World

      NAPIM’s Virtual Digital & Emerging Technologies Conference is Back, June 14–15, 2022
      CEMATEX Introduces Online Business Platform to Connect Global Textile Community
      PICO Chemical Celebrates 46 Years
      Label & Narrow Web

      Latest Breaking News From Label & Narrow Web

      Teklynx software helps Top Clean Injection validate labels
      Zeller+Gmelin named Berry Global’s 2021 Ink Supplier of the Year
      Videojet and Loftware partner to accelerate labeling automation
      Nonwovens Industry

      Latest Breaking News From Nonwovens Industry

      Rael Raises $35M in Series B Funding
      Schobertechnologies Offers Rotary Web-fed Converting Solutions
      Thorne Relaunches Gut Health Test with Microbiome Wipe
      Orthopedic Design & Technology

      Latest Breaking News From Orthopedic Design & Technology

      ManaMed's ManaSport Wearable Ultrasound Earns FDA Nod
      Ekso Bionics Names Jerome Wong as Interim CFO
      Exactech Completes First Surgeries Using Next-Gen Cage Glenoid
      Printed Electronics Now

      Latest Breaking News From Printed Electronics Now

      ams OSRAM Introduces New Horticulture LEDs
      Avery Dennison Launches AD Twist U7XM Inlays
      ARPA-E Funding Drives Innovation, Industry Partnerships at NREL

      Copyright © 2022 Rodman Media. All rights reserved. Use of this constitutes acceptance of our privacy policy The material on this site may not be reproduced, distributed, transmitted, or otherwise used, except with the prior written permission of Rodman Media.

      AD BLOCKER DETECTED

      Our website is made possible by displaying online advertisements to our visitors.
      Please consider supporting us by disabling your ad blocker.


      FREE SUBSCRIPTION Already a subscriber? Login