• 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
    Nutraceuticals for Men: Muscle Health and Performance Nutrition

    Aging in Place: Healthy Lifestyles Supplement Science-Based Solutions

    Getting an Edge in Esports: Meeting the Health Needs of Competitive Gamers

    Beyond CBD: Cannabis Compounds Warrant Recognition and More Research

    Leveling Out the Energy Segment for Mainstream, and Rethinking Caffeine
    Breaking News
    Certifications, Approvals and Patents
    Exclusives
    Industry & Market News
    People
    Products
    Regulatory
    Research
    Supplier News
    Supplier Insights
    Live From Shows
    Top News
    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

    Danone Celebrates 10th anniversary of Grant Program for Probiotics Research

    Stratum Nutrition’s Patent Portfolio Grows to Europe and Canada
    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

    GC Rieber Foundations Expand Philanthropic Efforts

    Danone Celebrates 10th anniversary of Grant Program for Probiotics Research

    Botanical Ingredient MorActive Evidenced to Relieve Back Discomfort

    Cargill’s Stevia Sustainability Program Benchmarked by FSA

    GOED Creates Infographic Highlighting Omega-3 Health Claims Approved in Europe
    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

    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

    Danone Celebrates 10th anniversary of Grant Program for Probiotics Research

    Stratum Nutrition’s Patent Portfolio Grows to Europe and Canada
    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

    Thorne Relaunches Gut Health Test with Microbiome Wipe

    Danone Celebrates 10th anniversary of Grant Program for Probiotics Research

    Beyond Raw Launches Concept X Pre-Workout Line

    Botanical Ingredient MorActive Evidenced to Relieve Back Discomfort

    Kyowa Hakko Appoints Dr. Colin Hill to Immuse Scientific Advisory Board
    Industry Events
    Live From Show Events
    Webinars
    All Companies
    Categories
    Trade Associations
    Company Capabilities
    International Buyers Guide Companies
    Nutrition21, LLC

    Botanic Healthcare LLC

    Verdure Sciences

    KLK OLEO

    Atlantia Clinical Trials
    Companies
    Product Releases
    News Releases
    Literature / Brochures
    White Papers
    Jobs
    VIdeos
    Services
    Add New Company
    International Buyers Guide Companies
    Nutrition21, LLC

    Botanic Healthcare LLC

    Verdure Sciences

    KLK OLEO

    Atlantia Clinical Trials
    • 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
    Columns

    Current Good Manufacturing Practices & the Private-Label Distributor

    PLDs are responsible for products introduced into interstate commerce and must ensure compliance with federal requirements.

    Current Good Manufacturing Practices & the Private-Label Distributor
    Related CONTENT
    • Testing Strategies in the Modern Nutraceuticals Industry
    • U.S.-Grown Soybean Oil Achieves FDA’s Qualified Heart Health Claim
    • Representative Mia Love to Co-Chair Congressional Dietary Supplement Caucus
    • UNPA Offering In-House PCQI Training for Food & Supplement Companies
    • UNPA to Host Additional PCQI Training for Food and Dietary Supplement Companies
    By Todd Harrison, Venable09.07.17
    Over the past several years, the Food and Drug Administration (FDA) has focused its attention on compliance issues related to the dietary supplement industry, generally, and on current good manufacturing practices (cGMPs), in particular. Indeed, we have seen an increase in the issuance of 483s and warning letters to Private Label Distributors (PLD) for failing to have adequate standard operating procedures related to cGMPs.

    The Federal Food, Drug, and Cosmetic Act (FFDCA) prohibits a person from introducing or delivering for introduction, or causing the delivery or introduction, into interstate commerce a dietary supplement that is adulterated for failure to comply with dietary supplement cGMP requirements (FFDCA § 402(g)). The cGMP regulations are located in Title 21 of the Code of Federal Regulations, Part 111. 

    To be clear, a PLD is ultimately responsible for products introduced or delivered for introduction into interstate commerce carrying its name and must ensure that the company and products are in compliance with all FFDCA requirements and pertinent regulations. Therefore, along with establishing standard operating procedures (SOPs) the PLD must implement directly, it must also develop oversight SOPs to ensure its contract manufacturing and fulfillment companies are in compliance.

    The cGMP regulations provide for broad and general requirements. To the extent that these regulations apply to the PLD, step-by-step how-to instructions and detailed explanations must be identified in the SOPs to implement the cGMP requirement. Below is a broad outline of both the direct and oversight SOPs that a PLD must develop. 

    Oversight SOPs
    As indicated, the agency has issued several warning letters emphasizing the importance of oversight SOPs for dietary supplement cGMPs. The letters stated that a dietary supplement distributor using contract manufacturers or labelers may be liable for cGMP violations by its contractors, explicitly noting that “‘agents vested with the responsibility, and power commensurate with that responsibility, to devise whatever means necessary to ensure compliance with the [FFDCA]’ can be held accountable for violations of the [FFDCA].”

    Though the PLD does not directly control the manufacturing and distribution of its products, it must have SOPs that ensure the oversight of product manufacture and distribution. Thus, oversight SOPs are an important component to demonstrate the PLD’s compliance with the relevant FDA regulations. These SOP’s should include: 

    1) In-Process Manufacturing Controls
    • The PLD must develop an SOP to oversee quality control personnel to ensure that manufacturing, packaging, labeling, and holding operations guarantee the quality of its products and that its products are packaged and labeled in accordance with established specifications. 
    • The PLD must be aware of the manufacturing activities performed by the contract and fulfillment companies in order to determine whether its products conform to established specifications before releasing the products for distribution.
    2) Incoming and Returned Product Quarantine, Review, and Release (Includes Labels, Packaging, Container/ Closure Systems, Product)
    • The PLD must develop an SOP that specifically targets the oversight of its contractors’ quality control responsibilities for conducting a material review and making a disposition decision for returned products, or for approving for release or rejecting any packaged and labeled dietary product for distribution.
    • The SOP must include monitoring the contractor’s written procedures for handling any returned products, incorporating when they may be salvaged, or when a returned product must be destroyed or otherwise suitably disposed.
    • The PLD must ensure that its contractors identify each unique lot within each unique shipment of received product in a manner allowing it to trace the lot to the contract manufacturer, the date received, the name of the received product, and the status of the received product. Specifically, The PLD must maintain the manufacturer lot numbers for traceability.
    3) Product Storage
    • The PLD must monitor its contractors’ written procedures for holding and distributing operations.
    • The SOPs must ensure the contractors have (and are following) direct SOPs that address the appropriate conditions of temperature, humidity, and light so that the identity, purity, strength, and composition of the PLD’s products are not affected.
    4) Product Expiration Dating and Stability Program
    5) Sample Approval and Shipping of Product
    6) Finished Product Quarantine, Review, and Release
    7) Product Rework
    8) Employee Hygiene Standards
    9) Facility Audits
    10) Inventory Control
    11) Change Control
    • The PLD must create process standards, monitor the implementation of the process, record all control changes, and routinely evaluate the effectiveness of the change control process.
    12) General Laboratory and Testing Requirements
    • The SOP must oversee the testing and examination process to ensure FDA compliance. For example, the PLD must ensure that the contract manufacturer conducts a minimum of one appropriate test or examination to verify an ingredient (i.e., usually a “dietary ingredient”) prior to its use.
    13) Testing Specifications
    • The PLD must ensure that the contract manufacturer has incorporated, among others, in-process specifications for any point, step, or stage in the master manufacturing record where control is necessary to help ensure that specifications are met for the identity, purity, strength, and composition of the
    product.
    14) Certificates of Analysis
    15) Independent Testing Program
    16) Information Technology Systems and Controls
    • The PLD must oversee the written master manufacturing record for each unique formulation of the PLD product manufactured.
    • The PLD must ensure uniformity in the finished batch. 
    17) Facility Design, Maintenance, and Security
    18) Cleaning and Sanitation
    19) Equipment Qualification, Use, and Maintenance
    20) Pest Control
    21) BSE Recordkeeping

    Direct SOPs
    In addition to the aforementioned oversight SOPs, the PLD should implement the direct SOPs listed below. 

    1) Introduction and Responsibilities
    2) Employee Orientation and Training
    3) Intake of Product Complaints
    4) Investigation of Complaints
    • The PLD must have written procedures for the handling of product complaints regarding the products it distributes and for adequately investigating complaints and documenting the findings of an investigation and follow-up.
    5) Reporting Serious Adverse Events to FDA (Form 3500A)
    6) Product Recalls and Market Withdrawals
    • The PLD must create a detailed SOP for product recalls and market withdrawals.
    7) Annual Review of Product Quality Standards
    8) Vendor Selection and Review
    9) Labeling Definitions and Standards

    Where Should a PLD Start when Drafting SOPs?
    As the PLD drafts its SOPs, the topics listed in this section should take priority. However, the PLD should take steps to ensure that all of the direct and oversight SOPs identified in this article are implemented. 
    1. Oversight: In-Process Manufacturing Controls
    2. Oversight: General Laboratory and Testing Requirements
    3. Oversight: Finished Product Quarantine, Review, and Release
    4. Oversight: Incoming and Returned Product Quarantine, Review, and Release (Includes Labels, Packaging, Container/Closure Systems, Product)
    5. Direct: Product Recalls and Market Withdrawals
    6. Direct: Investigation of Complaints
    7. Oversight: Product Storage
    8. Direct: Label Control Procedures
    9. Oversight: Product Expiration Dating and Stability Program
    10. Oversight: Sample Approval and Shipping of Product 

    Todd Harrison
    Venable

    Todd Harrison is partner with Venable, which is located in Washington, D.C. He advises food and drug companies on a variety of FDA and FTC matters, with an emphasis on dietary supplement, functional food, biotech, legislative, adulteration, labeling and advertising issues. He can be reached at 575 7th St. NW, Washington, D.C. 20004, Tel: 202-344-4724; E-mail: taharrison@venable.com.
    Related Searches
    • Regulations
    • Adulteration
    • Traceability
    • Quality Control
    Related Knowledge Center
    • Regulations
    • Contract Manufacturing
    • Dietary Supplements
    Suggested For You
    Testing Strategies in the  Modern Nutraceuticals Industry Testing Strategies in the Modern Nutraceuticals Industry
    U.S.-Grown Soybean Oil Achieves FDA’s Qualified Heart Health Claim U.S.-Grown Soybean Oil Achieves FDA’s Qualified Heart Health Claim
    Representative Mia Love to Co-Chair Congressional Dietary Supplement Caucus Representative Mia Love to Co-Chair Congressional Dietary Supplement Caucus
    UNPA Offering In-House PCQI Training for Food & Supplement Companies UNPA Offering In-House PCQI Training for Food & Supplement Companies
    UNPA to Host Additional PCQI Training for Food and Dietary Supplement Companies UNPA to Host Additional PCQI Training for Food and Dietary Supplement Companies
    NPA to Offer ‘FDA Experience’ Seminar  NPA to Offer ‘FDA Experience’ Seminar
    Balchem Supports AMA Recommendation for Increased Choline in Prenatal Vitamins Balchem Supports AMA Recommendation for Increased Choline in Prenatal Vitamins
    Nutraceutical Market Growth Driven by Health Conscious Consumers Nutraceutical Market Growth Driven by Health Conscious Consumers
    UNPA to Host Preventive Controls Qualified Individual (PCQI) Training UNPA to Host Preventive Controls Qualified Individual (PCQI) Training
    Understanding FTC Standards for Claims Substantiation Understanding FTC Standards for Claims Substantiation
    FDA Nominee Uses Supplements Daily and Promises Access During Tenure FDA Nominee Uses Supplements Daily and Promises Access During Tenure
    UNPA Offering New GMP Training Course June 27-28 UNPA Offering New GMP Training Course June 27-28
    CHPA Encourages Members to Participate in Supplement OWL CHPA Encourages Members to Participate in Supplement OWL
    Dietary Supplement Associations to Host May 10 Seminar Dietary Supplement Associations to Host May 10 Seminar
    ABC Endorses Supplement OWL Product Registry ABC Endorses Supplement OWL Product Registry

    Related Content

    • Dietary Supplements | Herbs & Botanicals | Quality & Safety | Regulations | Testing
      Testing Strategies in the  Modern Nutraceuticals Industry

      Testing Strategies in the Modern Nutraceuticals Industry

      Trusted analytical methods validate product quality and integrity.
      By Sean Moloughney, Editor 09.07.17

    • Breaking News | Cardiovascular Health | Certifications, Approvals & Patents | Packaging | Regulations
      U.S.-Grown Soybean Oil Achieves FDA’s Qualified Heart Health Claim

      U.S.-Grown Soybean Oil Achieves FDA’s Qualified Heart Health Claim

      Food manufacturers can promote eligible soybean oil products as U.S. grown and now, heart healthy.
      08.02.17

    • Breaking News | Dietary Supplements | Industry & Market News

      Representative Mia Love to Co-Chair Congressional Dietary Supplement Caucus

      Supplement trade associations applaud Utah Congresswoman’s position, which replaces Jason Chaffetz.
      08.01.17


    • Breaking News | Industry & Market News | Quality & Safety | Regulations

      UNPA Offering In-House PCQI Training for Food & Supplement Companies

      Trade group completes in-house training for Indena in Milan, Italy.
      07.20.17

    • Breaking News | Quality & Safety | Regulations | Regulatory News

      UNPA to Host Additional PCQI Training for Food and Dietary Supplement Companies

      ‘Preventive controls qualified individual’ training session scheduled for Aug. 16-18.
      07.13.17

      Trending
      • Leaven Essential To Launch Branded Botanical Extracts To Global Markets | Nutraceuticals World
      • Oregon Files Lawsuit Against GNC | Nutraceuticals World
      • Vitamin D3, Omega-3s, Exercise May Cumulatively Reduce Cancer Risk In Older Adults | Nutraceuticals World
      • Coca-Cola To Phase Out Honest Tea Brand By Year’s End, Citing Supply Chain Challenges | Nutraceuticals World
      Breaking News
      • 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
      • Danone Celebrates 10th anniversary of Grant Program for Probiotics Research
      • Stratum Nutrition’s Patent Portfolio Grows to Europe and Canada
      View Breaking News >
      CURRENT ISSUE

      May 2022

      • Aging in Place: Lifestyle Supplements Science-Based Solutions
      • Getting an Edge in Esports: Meeting Health & Nutrition Needs
      • Nutraceuticals for Men: Muscle Health and Performance Nutrition

      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

      Spate Announces Launch of French Data, New Color Complexion Trends Report
      Gojo Creates New All-Weather Purell Dispenser Built for Outdoor High Traffic Locations
      Women in Flavor and Fragrance Present 2022 Recognition Awards Dinner June 16
      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