Meet Supplement Industry Standards with Confidence

Dietary supplement and nutraceutical manufacturers face rigorous regulatory scrutiny worldwide. Whether you're meeting FDA cGMP requirements in the United States, NSF certification for retail placement, Informed Sport certification for athlete-safe products, or EU Food Supplements Directive compliance for European markets, comprehensive digital traceability is essential.

Trace Swift provides complete lot-level traceability designed specifically for supplement manufacturers. Our platform automates batch tracking, ingredient sourcing records, and compliance records so you can focus on formulation and production rather than paperwork.

Regulatory Standards We Support

The Cost of Poor Traceability

When a quality issue emerges in supplement manufacturing, the consequences extend far beyond regulatory penalties. Inadequate traceability systems can result in:

• Expanded recalls: Without precise batch tracking, recalls may need to include far more product than necessary, multiplying costs and market impact
• FDA Warning Letters: Traceability failures are among the most common 21 CFR Part 111 citations, leading to Warning Letters that become public record
• Retail delisting: Major retailers (Amazon, Walmart, CVS, GNC, Holland & Barrett) require robust traceability. Compliance failures mean lost shelf space
• Certification loss: NSF, Informed Sport, and other certifications require documented traceability. Failed audits mean lost certifications
• Customer injury claims: Without complete batch records, defending against product liability claims becomes extremely difficult
• Brand destruction: Public recalls and FDA enforcement actions can permanently damage consumer trust in supplement brands

What Supplement Regulations Require

Complete Batch Records

FDA 21 CFR Part 111 and equivalent regulations worldwide require comprehensive batch production records including:

• Master manufacturing record: Documented formula with specifications, procedures, and controls
• Batch production record: Actual production data showing what was done, by whom, and when
• Component records: Identity, purity, strength, and composition verification for each lot of raw materials
• In-process records: Documentation of critical control points during manufacturing
• Finished product records: Final batch testing, release, and lot code assignment

Ingredient Traceability

Every component used in supplement manufacturing must be traceable:

• Supplier qualification: Documentation that suppliers meet quality requirements
• Certificate of Analysis: Attach COA documents to incoming material lots
• Identity records: Supplier batch codes and lot information for each component
• Lot linkage: Connection between raw material lots and finished product batches
• Forward traceability: Ability to identify all products containing a specific ingredient lot

Rapid Recall Capability

Regulations require the ability to rapidly identify and retrieve affected products:

• Backward traceability: From finished product to all raw material lots used
• Forward traceability: From raw material lot to all finished products containing it
• Mock recall testing: Regular verification that recall procedures work

How Trace Swift Ensures Compliance

FDA 21 CFR Part 111 Compliance

The FDA's Current Good Manufacturing Practice regulations for dietary supplements establish comprehensive requirements for manufacturing, packaging, labelling, and holding operations. Trace Swift supports the traceability and documentation requirements throughout Part 111.

Subpart E - Requirement to Establish a Production and Process Control System

Trace Swift helps you meet §111.70 requirements:

• Master manufacturing records: Digital formula management with complete specifications
• Batch production records: Documentation of actual production including lot codes, quantities, dates, and personnel
• Process controls: Recording of critical parameters during production

Subpart J - Production and Process Control System: Requirements for the Batch Production Record

§111.255 requires batch production records that include:

• Identity of each component used (Trace Swift captures supplier lot codes)
• Actual weights and measures (recorded during production capture)
• Statement of actual yield (mass balance verification)
• Documentation of in-process controls (quality checkpoints)
• Documentation that the finished batch meets specifications

Subpart L - Production and Process Control System: Requirements for Packaging and Labeling

Trace Swift supports lot code assignment and tracking through packaging:

• Unique lot codes for finished products
• Linkage between bulk batch and packaged units
• Expiration date tracking and management

Third-Party Certification Support

Beyond regulatory compliance, third-party certifications open doors to premium retail channels and consumer trust. Trace Swift provides the documentation foundation these certifications require.

Purpose-Built for Supplement Manufacturing

Trace Swift understands the unique challenges of nutraceutical and dietary supplement manufacturing. Our platform is designed for businesses producing tablets, capsules, softgels, powders, liquids, gummies, and other supplement formats.

Common Supplement Manufacturing Scenarios

Ingredient Categories We Support

Trace Swift handles the full range of supplement ingredients:

• Vitamins & Minerals: Track lots, supplier batch codes, and expiry dates
• Botanicals & Herbals: Manage ingredient lots with supplier traceability
• Amino Acids & Proteins: Track sources, lots, and allergen information
• Probiotics: Track lots with expiry date management
• Specialty Ingredients: Handle proprietary blends and trademarked compounds
• Excipients & Processing Aids: Track fillers, binders, and other non-active ingredients

Beyond Compliance: Business Benefits

While regulatory compliance drives the need for traceability, Trace Swift delivers additional value to your supplement manufacturing operations:

Accurate Cost Calculation

Know the true cost of every product you manufacture. Trace Swift tracks actual ingredient costs at the batch level. When raw material prices change, see immediately how your margins are affected. Essential for competitive pricing in a crowded supplement market.

Formula Cost Optimisation

Compare ingredient costs across suppliers. Identify opportunities to optimise formulas without compromising quality. Cost cascade calculations show how ingredient changes affect finished product costs across your entire portfolio.

Inventory Control

Track inventory by lot and expiration date. First-expired, first-out (FEFO) management prevents waste of expensive specialty ingredients. Real-time stock visibility helps optimise purchasing and reduce carrying costs.

Production Efficiency

Digital production capture eliminates manual data entry and transcription errors. Barcode scanning speeds batch recording. Preparation summaries help plan production runs and warehouse picking.

Implementation in Days, Not Months

Unlike complex ERP systems requiring lengthy implementations and expensive consultants, Trace Swift is designed for rapid deployment:

1. Day 1-2: Setup - Create your account, set up ingredients, suppliers, and product formulas
2. Day 3-5: Go-Live - Start recording production batches in actual manufacturing
3. Ongoing: Support - UK-based email support helps you optimise your processes

Most supplement manufacturers achieve full cGMP traceability compliance within their first week. No consultants required. No lengthy configuration. Just practical software that works.

Transparent, Affordable Pricing

Supplement manufacturing software shouldn't require enterprise budgets. Trace Swift pricing starts at £90/month with no long-term contracts or hidden fees.

• All features included in every plan
• Unlimited ingredients, formulas, and batches
• Full FDA cGMP compliance capabilities
• Regular software updates and improvements
• Email support during UK business hours

Your Formulas Stay Confidential

Your supplement formulas represent significant R&D investment and competitive advantage. Trace Swift treats them with the confidentiality they deserve:

• Strict multi-tenant architecture ensures complete data isolation
• Your formulas are never shared, analysed, or accessed by other users
• Hosted on secure AWS infrastructure
• Encrypted data transmission and storage
• You retain full ownership of your data
• Follows GDPR principles for EU data protection

Frequently Asked Questions

Does Trace Swift work for small supplement manufacturers?

Yes. Trace Swift is designed for small to medium supplement manufacturers (5-150 employees). Our pricing and functionality are tailored for businesses that need professional cGMP compliance without enterprise complexity or cost. Whether you're producing 50 batches per month or 500, Trace Swift scales with you.

Will this help me pass an FDA inspection?

Trace Swift is designed to support FDA 21 CFR Part 111 compliance, particularly the batch production record requirements of Subpart J. We provide the traceability system, batch documentation, and supplier records that FDA inspectors expect to see. Many customers report that digital records make inspections significantly less stressful.

Can Trace Swift support NSF certification?

Yes. Trace Swift provides the traceability documentation and batch records required for NSF certification programmes. Our system tracks raw material lots through production to finished products, maintains supplier qualification records, and provides the audit trail NSF auditors need to see.

How does Trace Swift handle potency and strength tracking?

You can record potency and specification information in your input descriptions and notes. During production capture, you record actual quantities used from specific lots, maintaining the connection between inputs and batch composition. COA documents can be attached to incoming material lots.

What about stability and expiration date management?

Trace Swift tracks expiration dates for both raw materials and finished products. FEFO (First Expired, First Out) inventory views help you use materials before expiration. Finished product lot records include expiration date assignment for complete traceability.

Can I manage contract manufacturing for multiple brands?

Yes. Trace Swift supports multiple product lines and can maintain separate formulas for different customers or brands. Each batch is tracked independently with its own lot codes and traceability, while you maintain oversight of all production in one system.

How long does a traceability trace take?

Most traces complete in under 5 minutes. You can identify all products containing a specific ingredient lot, or all ingredients in a specific product batch, essentially instantly. This far exceeds the speed required for recall situations and makes audit responses straightforward.

What if I have questions during implementation?

We provide email support during UK business hours (Monday-Friday, 9:00-17:00 GMT). Most support queries receive responses within 24 hours. Our support team understands supplement manufacturing and can help you configure the system for your specific production processes.