Nov 2009.  At SupplySide West in Las Vegas, FDA's Dr. Bill Frankos spoke about FDA's  "Perspective on Qualifying Dietary Supplement Ingredient Suppliers."  For industry, it served notice that FDA ranks the subject of Supply Chain Security as an important part of GMP.  

A copy of his powerpoint is available.
NEW!   Need highly magnified images of  dietary ingredients? 
Our LCD Digital Microscope can produce photos or videos.
JACOBS COMPLIANCE SERVICES
                                                                                                      Take the Path to Regulatory Compliance in Stride
 

Services for Dietary Supplement & Food Companies 

 For Dietary Supplement & Food Companies:                             
  • Standard Operating Procedures
  • Dietary Supplement Labeling
  • Food Labeling
  • Market Summaries
  • Formula Review
  • Abstracts & Reviews
  • QA-QC White Papers
  • Close-the-Gap Reports
  • QA Trend Analysis 
  • GMP Training
  • Document Control Guidance
  • Templates
  • GMP Training Tools
    • Customizable Powerpoints
  • Complaint Handling & Management
  • Component Approval & Records
  • Process Verification Assistance
  • Allergens, GM, Vegetarian, Organic, etc.
  • Custom Forms (SOP documentation)
  • Draft Specifications & Info for
    • Raw Materials & materials w/contact 
    • Packaging Components
    • Finished Goods
  • Vendor Qualification & Records

 

 

 

 

 

 

  

       Areas of Specialty in your Regulatory Environment

  • Dietary Supplement Good Manufacturing Practices (GMP) (21 CFR 111)
  • the Federal Food Drug & Cosmetic Act
  • NLEA & DSHEA                    (labeling, "Supplement Facts", "Nutrition Facts")
  • FALCPA                                (allergens, gluten)
  • the Bioterrorism Act           (registration, supply chain safety)
  • California's Prop 65            (heavy metals)
  • FIFRA                                    (water, EPA pesticides)
  • Cleaning & Sanitization      (compliant with 21 CFR 110 or 21 CFR 111)
  • Adverse Event Reporting    (complaint handling)
  • International regulations    (Canada, EU, Japan, Australia, etc.)

Filing with foreign countries and need some help?  Ask about special services.

   Need help setting up a SIDI-style component information system?
SIDI is a house specialty!  Not familiar?  Check it out at one of the following links:

The American Herbal Products Association               The Council for Responsible Nutrition
        The Consumer Health Products Association                  The Natural Products Association

Contact Jacobs Compliance Services for 

             Consulting                                                        services on retainer, or by project
        Compliance Gap Audits                                              for GMP or sections of GMP
        Compliance Optimization Audits                               for economies & efficiencies
        Writing                                                    SOPs, templates, forms, White Papers, etc.
        GMP Training                                             for Managers, Supervisors, Technicians
        Technical Support                     formulation assistance, production troubleshooting
        Quality Management                         QA, QC, trend analysis, system updates, audits
           
Contacts for lab services, equipment purchases, hard-to-find raw materials!