• Login
    • Join
  • FOLLOW:
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Exclusives
    • Nutraceuticals
    • Markets
    • Health
    • Jobs
    • Events
    • Buyers' Guide
    • Showcases
    • More
  • Magazine
  • News
  • Exclusives
  • Nutraceuticals
  • Markets
  • Health
  • Jobs
  • Events
  • Buyers' Guide
  • Showcases
  • Current & Past Issues
    Features
    Columns
    Editorials
    Digital Edition
    Subscribe Now
    Advertise Now
    eNewsletter
    Editorial Guidelines
    Top Features
    A Kingdom of Their Own: Fungi Shine While Mushrooms Emerge as Market Stars

    The Pet Health Boom: Supplement Growth Set to Build on Rapid Expansion

    (Re)Open for Business: China’s Strong Demand for Natural Products Spells Opportunity for U.S. Brands

    Review Finds No Causative Connection Between Dietary Supplements and Eating Disorders

    KA! Empathogenics: Creating Calm and Connectedness with Inspiration from Nature
    Breaking News
    Certifications, Approvals and Patents
    Exclusives
    Industry & Market News
    People
    Products
    Regulatory
    Glossary
    Research
    Supplier News
    Supplier Insights
    Live From Shows
    Top News
    Stefan Pasiakos, PhD, Selected to Lead NIH Office of Dietary Supplements

    Verdure Sciences Receives Award for Sustainable, Ethical Turmeric Sourcing

    BGG Receives Patent for Saw Palmetto ID Method

    Premium Label & Packaging Solutions Receives Safe Quality Food (SQF) Certification

    Inulinase Enzymes May Benefit Gut Symptoms of FODMAP Digestion
    Exclusives
    Blogs & Guest Articles
    Health E-Insights
    Area Code 420
    eBook
    Antioxidants
    Dairy-Based Ingredients
    Enzymes
    Fatty Acids
    Fiber & Carbohydrates
    Green Foods
    Herbs & Botanicals
    Marine Nutraceuticals
    Minerals
    Omega 3s
    Probiotics & Prebiotics
    Proteins, Peptides, Amino Acids
    Sweeteners
    Vitamins

    Improving Taste and Mouthfeel of Plant-Based Protein Formulations

    A Kingdom of Their Own: Fungi Shine While Mushrooms Emerge as Market Stars

    Verdure Sciences Receives Award for Sustainable, Ethical Turmeric Sourcing

    BGG Receives Patent for Saw Palmetto ID Method

    ‘Uniquely Unbound’: Releasing the Potential, and Genius, of Walnuts
    Consumer Trends
    Contract Manufacturing
    Cosmeceuticals / Nutricosmetics
    Delivery & Dosage Technologies
    Dietary Supplements
    Flavors & Colors
    Functional Foods & Beverages
    Healthcare Trends
    Medical Nutrition
    Mergers & Acquisitions
    Natural/Organic
    Nutrition Bars
    Packaging
    Pet Nutraceuticals
    Quality & Safety
    Regulations
    Research
    Testing
    World Markets

    Stefan Pasiakos, PhD, Selected to Lead NIH Office of Dietary Supplements

    Improving Taste and Mouthfeel of Plant-Based Protein Formulations

    A Kingdom of Their Own: Fungi Shine While Mushrooms Emerge as Market Stars

    Verdure Sciences Receives Award for Sustainable, Ethical Turmeric Sourcing

    BGG Receives Patent for Saw Palmetto ID Method
    Bone & Joint Health
    Cancer Risk
    Cardiovascular Health
    Cognitive Function
    Diabetes & Blood Sugar Management
    Digestive Health
    Energy
    Eye Health
    Healthy Aging
    Immune Function
    Infant & Children's Health
    Inflammation
    Men's Health
    Mood Health & Sleep
    Oral Health
    Sexual & Reproductive Health
    Skin Health
    Sports Nutrition
    Weight Management/Weight Loss
    Women's Health

    A Kingdom of Their Own: Fungi Shine While Mushrooms Emerge as Market Stars

    ‘Uniquely Unbound’: Releasing the Potential, and Genius, of Walnuts

    Inulinase Enzymes May Benefit Gut Symptoms of FODMAP Digestion

    Gaming and Esports Health Concerns

    Bioiberica’s DAOgest Authorized as Novel Food ingredient in EU
    Industry Events
    Live From Show Events
    Webinars
    All Companies
    Categories
    Trade Associations
    Company Capabilities
    International Buyers Guide Companies
    BGG Americas, Inc.

    Botanic Healthcare LLC

    Verdure Sciences

    Nutrition21, LLC

    American FlexPack
    Companies
    Product Releases
    News Releases
    Literature / Brochures
    White Papers
    Jobs
    VIdeos
    Services
    Add New Company
    International Buyers Guide Companies
    BGG Americas, Inc.

    Botanic Healthcare LLC

    Verdure Sciences

    Nutrition21, LLC

    American FlexPack
    • Magazine
      • Current / Back Issue
      • Features
      • Editorial
      • Columns
      • Digital Edition
      • eNewsletter Archive
      • Editorial Guidelines
      • Subscribe Now
      • Advertise Now
    • Breaking News
    • Buyers' Guide
      • All Companies
      • Categories
      • Trade Associations
      • Company Capabilities
    • Nutraceuticals
      • Antioxidants
      • Dairy-Based Ingredients
      • Enzymes
      • Fatty Acids
      • Fiber & Carbohydrates
      • Green Foods
      • Herbs & Botanicals
      • Marine Nutraceuticals
      • Minerals
      • Omega 3s
      • Probiotics & Prebiotics
      • Proteins, Peptides, Amino Acids
      • Sweeteners
      • Vitamins
    • Markets
      • Consumer Trends
      • Contract Manufacturing
      • Cosmeceuticals / Nutricosmetics
      • Delivery & Dosage Technologies
      • Dietary Supplements
      • Flavors & Colors
      • Functional Foods & Beverages
      • Healthcare Trends
      • Medical Nutrition
      • Mergers & Acquisitions
      • Natural/Organic
      • Nutrition Bars
      • Packaging
      • Pet Nutraceuticals
      • Quality & Safety
      • Regulations
      • Research
      • Testing
      • World Markets
    • Health
      • Bone & Joint Health
      • Cancer Risk
      • Cardiovascular Health
      • Cognitive Function
      • Diabetes & Blood Sugar Management
      • Digestive Health
      • Energy
      • Eye Health
      • Healthy Aging
      • Immune Function
      • Infant & Children's Health
      • Inflammation
      • Men's Health
      • Mood Health & Sleep
      • Oral Health
      • Sexual & Reproductive Health
      • Skin Health
      • Sports Nutrition
      • Weight Management/Weight Loss
      • Women's Health
    • Online Exclusives
    • Webinars
    • Slideshows
    • Blogs & Guest Articles
    • Health E-Insights
    • Videos
    • Podcasts
    • Infographics
    • eBook
    • Whitepapers
    • Research
      • TrendSense
      • Monograph Center
      • White Papers
      • Research News
    • Jobs
    • Events
      • Industry Events
      • Live From Show Events
      • Webinars
    • Supplier Showcases
      • Companies
      • Product Releases
      • News Releases
      • Literature / Brochures
      • White Papers
      • Jobs
      • VIdeos
      • Services
    • About Us
      • About Us
      • Contact Us
      • Advertise With Us
      • Privacy Policy
      • Terms of Use
    Features

    Why Nutritional Brands Should Consider Legacy Pharma CMOs

    Traditional pharma CMOs operate quality systems to the rigorous standards of pharma manufacturing.

    Why Nutritional Brands Should  Consider Legacy Pharma CMOs
    By Tu T. Tran, VP of Sales & Marketing, Pharma Tech Industries09.10.18
    I’m going to go out on a limb here, and propose that there’s a strong case to be made for nutritional brands selecting contract manufacturing organizations (CMOs) that have traditionally catered to the pharmaceutical sector. You may think I’m comparing apples-to-oranges, but by the time you’ve finished digesting my argument, I believe you’ll agree that I’m actually talking apples-to-apples, and that this idea makes profound (if outside-the-box) sense.

    The most pressing reason for nutrition/nutraceutical brands to expand the search radius of their CMO exploration to consider legacy pharma portfolio CMOs revolves around quality control and assurance. There’s a “Quality by Design” aspect here and, as the nutrition industry has sometimes struggled with (usually undeserved) accusations of suspect quality control, why not seek out CMOs with pharma-grade QA/QC systems and relevant manufacturing equipment/lines?

    The Quality Equation
    A 2018 survey conducted by Nutraceuticals World indicated that more than two-thirds of companies consider quality control to be important when selecting a contract manufacturer. Clearly, this theme weighs heavily on people’s minds, and CMOs that meet the rigorous standards of the pharma sector can offer a broad selection of superior QC equipment and processes.

    While currently serving as vice president of sales and marketing for Pharma Tech Industries, a pharmaceutical contract manufacturer and packager that specializes in powder-based products, my career has straddled both sides of the fence—the CMO side (Nellson and Heinz in addition to Pharma Tech) as well as the CPG branded portfolio (Nestle, Heinz). I understand firsthand the enormity of manufacturing partner selection. I know this exercise is not simply a straightforward RFQ/RFP (Request for Quote/Price) execution wherein the lowest bidder wins, but one that extends far beyond economics to revolve around critical factors encompassing stewardship, innovation, capacity, and quality.

    Consider the times in which we live. In today’s era of litigious consumer counsel and social-media transparency, and immediacy, companies must work diligently to assure that their market share and consumer trust, accrued over years and decades, does not evaporate overnight. Unfortunately, organizations can all too easily imagine the damage their brands may suffer in the wake of a single quality-related incident, recall, complaint, or warning.

    Companies that have closely nurtured and protected their brands over extended periods fear that once they turn manufacturing over to a CMO, this closely guarded control will be lost. They worry that this third party may come to hold greater downstream stewardship over their brands than they themselves do.

    Again, this is why the CMO selection process is profoundly important, and why I believe traditional pharma providers offer an attractive and compelling alternative for nutrition and nutraceutical brands to consider as they search for a manufacturing partner.

    Why do I feel that way? In short, pharma CMOs are inherently held to higher standards of operational, quality, and testing thoroughness—as required by the strict regulatory landscape of their products: Rx, OTC, medical device, etc. Out of necessity, this rigor precipitates architecture, infrastructure, design, and execution protocols that exceed respective environments in adjacent product categories outside of pharma.
     
    The pharma landscape is governed by 21 CFR 211—the Code of Federal Regulations published by executive departments and agencies of the U.S. government. The CFR contains 50 titles—wherein Title 21 pertains to food and drugs. Part 211 (pharmaceuticals) is comparatively more rigorous, and contains regulations that are much more prescriptive than Part 110 (food). While dietary supplement regulations in Part 111 are more similar to pharmaceuticals, they are also intentionally written with “wiggle room,” loosening required controls concerning assay of ingredients and their labeling.

    CMO Support
    Let’s examine the following points while considering the use of legacy pharma CMOs for nutritional and nutraceutical brands.

    Rigor: Pharma CMOs are accustomed to a high level of operational brand stewardship, having historically produced OTC/Rx products marketed in environments of much greater safety, cleaning, and regulatory rigor per the requirements of 21 CFR 211 (GMP regulations) and ICH Q10.

    Testing: The process and product testing and validation carried out by pharma CMOs is second to none. We have the ability to perform USP compendial methods in addition to customer supplied methods. All USP analytical testing methodology is verified onsite prior to use, and all customer-provided methodology is transferred per internally established procedures aligned with ICH Q2(R1) and USP <1225> requirements. Validation of manufacturing processes is aligned with FDA Process Validation guidance.

    Isolation: Pharma CMOs isolate lines, suites, and rooms for cleaning, contamination control, and privacy. A line clearance is performed between every lot, and a major cleaning is performed to prevent any cross-contamination between different products. Facility designs meet requirements of 21 CFR 211.42.

    Clean processing environment: Conditions that mitigate quality exposure are key to ensuring upstream product integrity and downstream brand equity for pharma CMOs. Moreover, we perform environmental monitoring for viable organisms in production environments—holding to USP purified water microbial limits for potable water and to strict limits for air sampling.
    Climate controlled environment: Per the requirements of 21 CFR 211.142, pharma CMOs control climate within temperature and humidity specs that facilitate product quality and shelf life.

    Cross-industry relevant capabilities: Legacy pharma CMOs are fully capable of producing nutritional food/supplement applications using existing equipment assets, including: 1) Processing: ribbon blending, automatic cartoning/packaging, metal detection; 2) Packaging: automated and weight-controlled powder filling into pouches (sticks to sachets) and bottles of every size and shape; 3) Product format: free flowing powder (supplements, protein, digestive) and solid (effervescent tablets, capsules); 4) Vertical integration: bottle blow molding and component injection molding; 5) Flexibility: nimble, upside capacity and entrepreneurial CAPEX investment tolerance; 6) Raw material handling: full spectrum of scope from bags and drums, to super sacks, rail cars, and silos.

    Conclusion
    Nutritional brands seeking production partners should consider expanding their search radius to include legacy pharma portfolio CMOs for their nutritional product applications needs. Traditional pharma CMOs operate quality systems to the rigorous standards of pharma manufacturing.

    About the author: Tu T. Tran is vice president of sales & marketing for Pharma Tech Industries (www.pharma-tech.com). He came to PTI with more than 20 years of business development experience in a career spanning engineering, manufacturing, sales and marketing, including a strong background in nutraceuticals.
    Related Searches
    • Regulations
    • Quality Control
    • labeling
    • survey
    Related Knowledge Center
    • Contract Manufacturing
    • Testing
    • Quality & Safety
    • Dietary Supplements
    Suggested For You
    Nutraceuticals World Nutraceuticals World
    Pharma Tech Industries Pharma Tech Industries
    Foundations for Formulating Skin Care Products Foundations for Formulating Skin Care Products
    Deerland Enzymes and Probiotics Obtains FSSC 22000 Certification Deerland Enzymes and Probiotics Obtains FSSC 22000 Certification
    Botanical Adulterants Prevention Program Published Bulletin on Boswellia Resin Botanical Adulterants Prevention Program Published Bulletin on Boswellia Resin
    CRN Voluntary Guidelines Reinforce Industry Commitment to Consumer Safety CRN Voluntary Guidelines Reinforce Industry Commitment to Consumer Safety
    Tips & Tricks for Walking the Insurance Application Minefield Tips & Tricks for Walking the Insurance Application Minefield
    UNPA and Healthnotes Partner to Promote Vitature Supply-Chain Management Software UNPA and Healthnotes Partner to Promote Vitature Supply-Chain Management Software
    ACG GROUP Offers Track & Trace Solutions ACG GROUP Offers Track & Trace Solutions
    NattoPharma Unveils Organizational Changes for Growth NattoPharma Unveils Organizational Changes for Growth
    An Interview with Arun Natarajan of Avlaan Inc. An Interview with Arun Natarajan of Avlaan Inc.
    Thorne Launches Hemp Oil + to Relieve Stress and Discomfort, Support Gut Health Thorne Launches Hemp Oil + to Relieve Stress and Discomfort, Support Gut Health
    HPA-China Hosting Annual Nutrition & Health Summit in Shanghai HPA-China Hosting Annual Nutrition & Health Summit in Shanghai
    AHP Releases Monograph Standards for Motherwort Aerial Parts AHP Releases Monograph Standards for Motherwort Aerial Parts
    24 Years After DSHEA, Industry Still Lacks ODI Clarity 24 Years After DSHEA, Industry Still Lacks ODI Clarity

    Related Buyers Guide Companies

    • Nutraceuticals World

      ...
      03.15.23

    • Pharma Tech Industries

      ...
      11.05.20

    • Delivery & Dosage Technologies | Quality & Safety | Regulations | Skin Health
      Foundations for Formulating Skin Care Products

      Foundations for Formulating Skin Care Products

      Developing targeted solutions for skin health requires some basic knowledge of formulary and regulatory standards.
      By Dr. Krystal Crawford, ND, MS, RH 09.04.18


    • Breaking News | Enzymes | Probiotics & Prebiotics | Quality & Safety | Regulations | Regulatory News | Supplier News

      Deerland Enzymes and Probiotics Obtains FSSC 22000 Certification

      Company prioritizes compliance with FDA’s Food Safety Modernization Act of 2011.
      08.03.18

    • Breaking News | Herbs & Botanicals | Industry & Market News | Quality & Safety

      Botanical Adulterants Prevention Program Published Bulletin on Boswellia Resin

      Bulletin focuses on adulteration and substitution of boswellia with resins from related species.
      07.12.18

    Loading, Please Wait..
    Trending
    • Soviets Took Probiotics To The Next Level
    Breaking News
    • Stefan Pasiakos, PhD, Selected to Lead NIH Office of Dietary Supplements
    • Verdure Sciences Receives Award for Sustainable, Ethical Turmeric Sourcing
    • BGG Receives Patent for Saw Palmetto ID Method
    • Premium Label & Packaging Solutions Receives Safe Quality Food (SQF) Certification
    • Inulinase Enzymes May Benefit Gut Symptoms of FODMAP Digestion
    View Breaking News >
    CURRENT ISSUE

    May 2023

    • Cellular Aging and Longevity: Ingredients for a New Age of Health
    • Addressing the Plastic-Packaging Problem: Getting to Zero-Waste with Zero Compromise
    • Moms Raise the Bar for Kids Supplements
    • Building on Steps to Improve Children’s Health Around the World
    • FDA Remains Focused on Modernizing DSHEA
    • View More >

    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

    Stefan Pasiakos, PhD, Selected to Lead NIH Office of Dietary Supplements
    Verdure Sciences Receives Award for Sustainable, Ethical Turmeric Sourcing
    BGG Receives Patent for Saw Palmetto ID Method
    Coatings World

    Latest Breaking News From Coatings World

    Indorama Ventures and Carbios Reaffirm Partnership to Build PET Biorecycling Plant
    AkzoNobel Powder Coatings Enhances Digital Services with Launch of My Interpon Portal
    PPG Opens Color Creation Lab with Chery Automobile in China
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    MPO's Most-Read Stories This Week—June 3
    CardioRenal’s TENOR Device Receives Breakthrough Device Designation from FDA
    LifeQ Unveils New 24-Hour Sleep Solution
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Terran Biosciences, Pierre Fabre Ink Exclusive Licensing Deal for Idazoxan
    ASM Research Chemicals Launches Development Packs for API Manufacturing
    WuXi Increases Manufacturing Capacity in Germany
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    L'Oréal North Asia President Discusses China's Consumer Sector Recovery & Premium Beauty Trends
    Kiehl’s Celebrates Pride by Supporting The Trevor Project
    L’Oréal & UNESCO Announce 2023 Laureates of the For Women in Science International Awards
    Happi

    Latest Breaking News From Happi

    An Eco-Friendly & Stylish PET Dropper for Cosmetic Products New from Epopack
    Color Street Celebrates Pride Month with Limited-Edition ‘Over the Rainbow’ Nail Strips
    Olay Rolls Out Sensitive Skin Line
    Ink World

    Latest Breaking News From Ink World

    Weekly Recap: INX Digital, hubergroup and HP Top This Week’s Stories
    Mactac Acquires Canadian Roll Label Distributor Label Supply
    WestRock Advances its Commitment to a Sustainable Future
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Schreiner's Pharma-Comb IL Label supports clinical trial cancer medication
    First Anytron ANY-JET III digital label press installed in Korea
    FPA announces Kasie Fairbarn as elected ELC co-chair
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Harper Hygienics Launches Hemp-Based Intimate Care Wipes
    What You’re Reading on Nonwovens-Industry.com
    Biodiapers Signs Agreement with Sicam
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    ODT's Most-Read Stories This Week—June 3
    Augmedics Debuts New Features, Indications for xvision Platform
    Artelon Closes $20M Series B Funding
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Weekly Recap: Francisco Melo, Smart Skis, onsemi Top This Week’s Stories
    DIC Acquires Photoresist Polymers Manufacturer PCAS Canada
    Arkema Collaborates with Habitat for Humanity Philadelphia

    Copyright © 2023 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