Supplement Manufacturing System
Dietary supplement and nutraceutical manufacturers need strict GMP compliance, complete ingredient traceability, and quality documentation. Sprint GMP helps supplement companies meet FDA requirements and maintain quality standards that protect consumers.
Supplement Manufacturing Requirements
Dietary supplements are regulated by FDA under GMP requirements. Manufacturers must maintain complete batch records, ingredient traceability, quality control testing, and complaint handling procedures. Supplement companies face strict oversight and must be able to demonstrate compliance during FDA inspections.
Sprint GMP for Supplement Manufacturers
Ingredient Traceability
Supplement manufacturers must track every ingredient from supplier receipt through production to finished product. Sprint GMP maintains complete lot-level traceability, so you can quickly identify which supplement batches contain specific ingredients. This is essential for quality issues, recalls, and FDA inspections.
FDA Requirement: Maintain records to trace all ingredients used in supplement production.
Batch Production Records
FDA requires complete batch production records showing all ingredients, quantities, processing steps, and quality control results. Sprint GMP automatically creates batch records with full ingredient lot tracking, formula documentation, and test results. Every batch is fully documented and ready for FDA review.
FDA GMP Requirement: Maintain complete batch production and control records.
Quality Control Testing
Supplements require quality control testing for identity, purity, strength, and composition. Sprint GMP provides structured test records that link to specific batches, store test results, and track approval status. The system ensures all required testing is documented before products are released.
FDA Requirement: Test all incoming ingredients and finished products for identity, purity, strength, and composition.
Labeling Compliance
Supplement labels must accurately reflect product contents and meet FDA requirements. Sprint GMP tracks formula versions and batch compositions, making it easy to verify label accuracy. The system helps ensure your labels match what's actually in the product.
Use Case: Verify that supplement labels accurately list all ingredients and quantities before products are released.
Complaint Handling
Supplement companies must systematically handle customer complaints and adverse events. Sprint GMP tracks complaints, links them to specific batches, documents investigations, and maintains records required for FDA reporting. The system helps identify trends that may indicate product quality issues.
FDA Requirement: Establish procedures for complaint handling and adverse event reporting.
Key Features for Supplement Manufacturers
- Complete ingredient traceability from supplier to finished product
- Batch production records with ingredient lot tracking
- Quality control test records for identity, purity, and strength
- Formula version control for accurate labeling
- Complaint and adverse event tracking
- Rapid recall capability for affected batches
- Supplier certificate management
Perfect for Supplement Manufacturers
Whether you're making vitamins, herbal supplements, protein powders, or specialized nutraceuticals, Sprint GMP provides the traceability and documentation you need for FDA compliance. Start your free trial to see how our system can help you meet GMP requirements and protect your customers.
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