• 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
    PowerBar Maker Jennifer Maxwell Drums Up Organic Energy with JamBar Brand

    Economic Pressures Lead to Slower Growth in Dietary Supplement Industry

    Supporting Musculoskeletal Health: Tending to Muscles, Joints, and Bones

    2023 Contract Manufacturing Survey

    Dosage and Delivery Innovations Help Manufacturers Meet Common Challenges
    Breaking News
    Certifications, Approvals and Patents
    Exclusives
    Industry & Market News
    People
    Products
    Regulatory
    Glossary
    Research
    Supplier News
    Supplier Insights
    Live From Shows
    Top News
    Wiley Eliminates Outer Carton From Packaging to Reduce Waste

    ACG Expands as Vantage Nutrition Acquires ComboCap and its Dual-Chamber Capsule Technology

    Melodea Launches New Plastic-Free Packaging Solution

    GOED and NASC Announce Strategic Partnership

    NPA: ‘Major Victory’ in Colorado After Amendment to Eating Disorder Bill
    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

    Wiley Eliminates Outer Carton From Packaging to Reduce Waste

    PowerBar Maker Jennifer Maxwell Drums Up Organic Energy with JamBar Brand

    Harmonizing the EU's Upper Limits For Micronutrients

    GOOD Meat Receives FDA Go-Ahead for Cultured Meat

    IFF Achieves Industrial-Scale Production of Anaerobic Probiotic Strain
    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

    Wiley Eliminates Outer Carton From Packaging to Reduce Waste

    ACG Expands as Vantage Nutrition Acquires ComboCap and its Dual-Chamber Capsule Technology

    PowerBar Maker Jennifer Maxwell Drums Up Organic Energy with JamBar Brand

    Economic Pressures Lead to Slower Growth in Dietary Supplement Industry

    Melodea Launches New Plastic-Free Packaging Solution
    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

    Economic Pressures Lead to Slower Growth in Dietary Supplement Industry

    NPA: ‘Major Victory’ in Colorado After Amendment to Eating Disorder Bill

    Nordic Naturals Debuts Probiotic Line in More Than 375 Sprouts Farmer’s Markets

    DolCas Biotech's Curcugen Featured in Beauty-From-Within Supplement

    NOW Tests Bromelain Supplements Purchased on Amazon
    Industry Events
    Live From Show Events
    Webinars
    All Companies
    Categories
    Trade Associations
    Company Capabilities
    International Buyers Guide Companies
    American FlexPack

    Chenguang Biotech Group Co., Ltd.

    Nutrition21, LLC

    Verdure Sciences

    JRS Pharma
    Companies
    Product Releases
    News Releases
    Literature / Brochures
    White Papers
    Jobs
    VIdeos
    Services
    Add New Company
    International Buyers Guide Companies
    American FlexPack

    Chenguang Biotech Group Co., Ltd.

    Nutrition21, LLC

    Verdure Sciences

    JRS Pharma
    • 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
    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
    • Adulterated
    • equipment
    • Traceability
    • Dietary Supplement
    Related Knowledge Center
    • Quality & Safety
    • Contract Manufacturing
    • Regulations
    • 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 Features

    • 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

    Loading, Please Wait..
    Trending
    • Shiitake Mushroom Extract Appears Helpful In HPV Infections
    • The Functional Chocolate Company Launches Painfree Chocolate
    Breaking News
    • Wiley Eliminates Outer Carton From Packaging to Reduce Waste
    • ACG Expands as Vantage Nutrition Acquires ComboCap and its Dual-Chamber Capsule Technology
    • Melodea Launches New Plastic-Free Packaging Solution
    • GOED and NASC Announce Strategic Partnership
    • NPA: ‘Major Victory’ in Colorado After Amendment to Eating Disorder Bill
    View Breaking News >
    CURRENT ISSUE

    March 2023

    • Supporting Musculoskeletal Health: Tending to Muscles, Joints, and Bones
    • Dosage and Delivery Innovations Help Manufacturers Meet Common Challenges
    • 2023 Contract Manufacturing Survey
    • Manufacturing Dietary Supplements in Economic Uncertainty
    • Beyond Antioxidants: The Power of Berries
    • A Paradigm Shift for Antioxidants?
    • Ayana Bio on Path to Scale Bioactives Derived from Plant Cell Cultures
    • Nuritas: Leveraging Artificial Intelligence to Speak the Language of Life
    • Dietary Supplement Quality Assurance Programs Critical to Natural Products Industry Success
    • Innovation in Nutraceuticals: Dose Forms and Application Science Help Meet Consumer Demand
    • 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

    Wiley Eliminates Outer Carton From Packaging to Reduce Waste
    ACG Expands as Vantage Nutrition Acquires ComboCap and its Dual-Chamber Capsule Technology
    Melodea Launches New Plastic-Free Packaging Solution
    Coatings World

    Latest Breaking News From Coatings World

    AkzoNobel Appoints Ricardo Rosso as Pontiac Site Manager
    Sherwin-Williams Publishes Sustainable Packaging White Paper
    Heubach Launches Automotive Styling Shades 2027
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    Q’Apel Medical Inc. Receives CE Mark for Walrus Balloon Guide Catheter
    Medinbox and Abbott Partner to Increase Efficiency in Electrophysiology Labs
    Bronwyn Brophy Named CEO at Vitrolife AB
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Evotec, BMS Expand Strategic Neurodegeneration Pact
    Regeneron, Sonoma Biotherapeutics Partner on Treg Cell Therapies
    Astellas, MIMETAS Enter Strategic Immuno-Oncology Alliance
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Millie Bobby Brown’s Florence by Mills Launches Eye-Centric Color Cosmetics Line
    Colorsmith Introduces ‘Salon-Quality’ Stylers for Men
    Panama Jack Launches Tropical Fragrances, Essential Oils & Body Mists
    Happi

    Latest Breaking News From Happi

    Kao Launches Space Shampoo Sheet
    Procter & Gamble Brings Tide ‘Loads of Hope’ Relief to Residents Affected by Deadly Tornado Outbreak in Mississippi
    Sederma Introduces Active Ingredient to Address Pigment Disorders
    Ink World

    Latest Breaking News From Ink World

    NAPIM Honors 2023 Ault, Pioneer Award Recipients
    Kodak to Showcase Prepress and Print Technologies at Print China 2023
    CPIPC Hosts Technical Dinner
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    CORLABEL invests in HP and a second GM finishing machine
    Elkem's Sean Duffy receives AWA Leadership Award
    eProductivity Software acquires Tharstern Group
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Ahlstrom Releases Sustainability Report
    Albaad Uses Upgrades Lenzing Fibers in Flushable Wipes
    Midwest Filtration, Monadnock Announce Partnership in Filtration
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Conventus Flower Ortho Appoints Jeff Culhane as COO
    Solid Growth Forecast for OTC Braces and Supports Market
    Exactech Boosts AI Expertise with Licensing Deal, Team of Scientists
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Japan Display to Acquire JOLED IP
    Graphenest, Hubron to Partner on Graphene Project
    CSEM Nominates Andreas Rickenbacher as New Chair of the Board

    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