Supplement & Distributor SOP’s and Procedures

If you market or sell your own label of supplement or food product that is manufactured by a third party, such as a contract manufacturer or copacker, then you are responsible for its manufacture and labeling—even if you never physically touch the product.

Marketers and Private Label sellers and distributors of supplements are required to have several procedures and SOP’s to ensure you are meeting FDA GMP (Good Manufacturing Practices) requirements. Some of the areas every supplement product marketer needs to have and follow, include controls and review of labels and packaging, compliance marketing, websites, web pages and health claims, product registration, quality policies, handling complaints and adverse event reports, and safety procedures.

Below is a partial list of SOP’s and standard operating procedures, policies and protocols that every own-label distributor and brand marketer in the supplement industry should consider having in order to meet FDA GMP requirements.

1. Supplier Qualification, Manufacturer, Copacker and Vendor Qualification
   1. Supplier Audits and Inspections (Virtual Inspections, In-person Audits)
   2. Contract Manufacturer and Packager Qualification
   3. Contract Laboratory Qualification
   4. Purchasing Requirements
2. Registering Product in Your Country/State
   1. Import / Export Requirements
3. New Product Development
   1. Outline of Stage Gates and Review Process, Timeline
   2. Regulatory and Food Safety Review
4. Marketing and Claims Review
   1. Label Development, Review and Approval
   2. Website and Marketing Copywriting Review
   3. Claims Substantiation Policy
5. Communications Policies
   1. Social Media and Customer Service for Product and Health Claims
   2. Email and Social Media Policy
   3. Confidentiality Policy and Non-Disclosure Agreements
6. Personnel
   1. Employee Training Program
   2. Personnel Responsibilities / Job Descriptions
   3. Employee Qualifications
   4. Personnel Health and Hygiene
   5. Employee Safety
   6. Emergency Response & Crisis Management
   7. Handling Worker Injury
7. Product Quality Policy
   1. Authorities and Responsibilities of the Quality Unit
   2. Preventing Adulteration & Sabotage
   3. Product Testing
   4. Testing Lab Qualification
   5. Product Inspection
   6. Product Approval and Release
   7. Specifications and Certificates of Analysis
   8. Material Review and Disposition (Decision)
   9. Out of Specification (OOS) Investigation
   10. Representative and Reserve Samples
8. Traceability
   1. Inventory Control
9. Complaints Handling
   1. Adverse Event Handling (including Serious Adverse Event reporting)
   2. Internal Complaint Handling / Employee Happiness
10. Recordkeeping
    1. Document Management
    2. Electronic Records and Electronic Signatures
11. Facility Management
    1. Pest Control
    2. Warehouse Operations
12. Transportation of Product
13. Returned Goods
14. Product Recall
15. Regulatory Inspections

Contact us to discuss your needs as a distributor, marketer or seller of dietary supplements and healthy foods, and ensure compliance with FDA GMP’s.