Description

Procedures, SOP’s and Forms — Start-Up Pack for FDA Regulated Supplements, Foods and Cosmetic Brands

Standard Operating Procedures are required for all finished product, labeled dietary supplement brands in the U.S.

FDA and other regulatory bodies require finished product brand owners to have written procedures and records supporting their compliance with Good Manufacturing Practices (GMP) — even if you never touch the actual product.

Remember the Golden Rule of good quality assurance practices simply — if it’s not written down, it didn’t happen.

Federal and state mandates for GMP also require all supplement and food brands to record and investigate product complaints, train employees and staff, store the product correctly, qualify suppliers to ensure quality product, and review and approve all product labels.

The following SOP are generally required (at minimum) for all food and supplement brands:

1. Product Recall
2. Product Complaints
3. Adverse Event Reporting
4. Employee Training
5. Storage Conditions
6. Supplier Qualification
7. Product Qualification and Approval
8. Label Development/Review and Approval
9. Product Returns
10. Recordkeeping
11. Others, as needed

Proper records must accompany all procedures or SOP, as documentary evidence that the procedure was followed. These are often called ‘forms’ or ‘records’, if electronically kept.

Template forms associated with the above SOP are provided upon request: SOP Format Template, SOP Log, Complaint Log, Training Record, Recall Forms, Adverse Event Reporting Form, Approved Supplier List.

Upon review of document drafts, a followup discussion and final revision of forms is included.

All SOP and forms are provided as editable, in Word or Google Doc format.