SOP Solutions
Effective Standard Operating Procedures are a requirement for all dietary supplement and natural product companies. I provide you with the updated formats needed to meet the new standards and guide you to “tweak” and implement them. These include -
[1] The all-important, updated 30-page SOPs format for you to "tweak" for your company
[2] The critical clauses to include in your Manufacturer’s standard contract form and
[3] The Structure and Function Claims Notice format - required FDA notice within 30 days of first marketing a claim.
Three Step Training - Establishing SOPs, Setting-Up implementation, Training in the SOPs...
Once your papers are in order, I conduct in-depth training webinars for your Company and Certify your compliance for FDA SOP/GMP regulations and training. In addition, I have a series of continuing education webinars to keep your staff and company leaders on the leading edge.
Contact me through the Contact Form on the Home Page of this web site.
ONCE THE INSPECTORS ARE AT YOUR DOOR, IT IS WAY TOO LATE!
PREPARATION IS YOUR LOGICAL SOLUTION – 973.300.4594.
Ralph …
Ralph Fucetola JD
[1] The all-important, updated 30-page SOPs format for you to "tweak" for your company
[2] The critical clauses to include in your Manufacturer’s standard contract form and
[3] The Structure and Function Claims Notice format - required FDA notice within 30 days of first marketing a claim.
Three Step Training - Establishing SOPs, Setting-Up implementation, Training in the SOPs...
Once your papers are in order, I conduct in-depth training webinars for your Company and Certify your compliance for FDA SOP/GMP regulations and training. In addition, I have a series of continuing education webinars to keep your staff and company leaders on the leading edge.
Contact me through the Contact Form on the Home Page of this web site.
ONCE THE INSPECTORS ARE AT YOUR DOOR, IT IS WAY TOO LATE!
PREPARATION IS YOUR LOGICAL SOLUTION – 973.300.4594.
Ralph …
Ralph Fucetola JD
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SOP Contents Outline
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The Manual consists of the following items:
1. Introduction / Index 2. Refund, Delivery & Returns Policies 3. Standard Disclaimers; Site Use Statement 4. Standard Waivers: Model – Testimonial – Clinical Study 5. Email Privacy Policy 6. Document Retention Policy 7. QC Procedures / Claims, Complaints, Coordination 8. Contract Manufacturer Agreement GMP Enforcement Terms 9. Order Processing Procedure 10. Bookkeeping and Account Management |
11. Order Record Keeping and Retrieval; AER Reporting
12. Emergency Planning and Crisis Management 13. Payment Card Industry Data Security System 14. Private Labeling 15. Receiving & Storage of Inventory and Returns 16. Returns and Recalls 17. Complaint Form 18. Change Controls / New SOPs 19. CAPA SOP 20. CCDS (Company Core Data Sheets) SOP 21. New Employee Qualification and Training |
Sample Certificate of Completion
