Meet Pharmaceutical Manufacturing Standards with Confidence

Pharmaceutical manufacturers operate under some of the most stringent regulatory requirements in any industry. Whether you're meeting FDA cGMP requirements in the United States, EU GMP for European markets, WHO prequalification for global health programmes, or PIC/S standards for international recognition, comprehensive digital traceability is not optional—it's essential.

Trace Swift provides complete lot-level traceability designed for pharmaceutical manufacturing environments. Our platform supports batch production records, raw material tracking, and compliance records so you can focus on producing quality medicines rather than managing paperwork.

Regulatory Standards We Support

The Cost of Poor Traceability

In pharmaceutical manufacturing, traceability failures carry consequences far beyond regulatory penalties. Patient safety depends on your ability to trace every component of every batch. Inadequate systems can result in:

• Patient harm: Inability to rapidly identify and recall affected products puts patients at risk—the most serious consequence of traceability failures
• Expanded recalls: Without precise batch tracking, recalls may need to include far more product than necessary, multiplying costs and supply disruptions
• FDA Warning Letters: Traceability and batch record failures are among the most common 21 CFR 211 citations, resulting in public Warning Letters
• Import alerts: FDA can place manufacturers on import alert, effectively blocking US market access
• EU GMP non-compliance: EMA can suspend manufacturing authorisations, halting European sales
• WHO prequalification loss: Loss of WHO prequalification excludes products from UN procurement and global health programmes
• Contract loss: Pharmaceutical companies and healthcare systems require robust traceability from contract manufacturers
• Criminal liability: Serious GMP violations can result in criminal prosecution of responsible individuals

What Pharmaceutical Regulations Require

Complete Batch Records

FDA 21 CFR 211 and equivalent regulations worldwide require comprehensive batch production and control records including:

• Master production record: Documented formula, specifications, manufacturing instructions, and in-process controls
• Batch production record: Complete documentation of actual production including component lots, quantities, equipment, personnel, and deviations
• Component records: Identity testing, supplier qualification, receipt, sampling, and release for each lot of raw materials
• In-process controls: Documentation of critical process parameters and in-process testing
• Laboratory records: Testing results, out-of-specification investigations, and release decisions
• Packaging records: Line clearance, reconciliation, and lot code assignment

Trace Swift supports the traceability elements of these requirements: master formula management, batch production records with component lot tracking, supplier batch codes, goods receipt records, quality inspection checkpoints, and batch release workflows. Laboratory testing, in-process analytical testing, and line clearance documentation are typically managed in separate QC/LIMS systems.

Complete Traceability Chain

Pharmaceutical traceability must be complete and bidirectional:

• Component traceability: Every raw material lot traced from supplier through manufacturing to finished products
• Forward traceability: From any component lot to all finished product batches containing it
• Backward traceability: From any finished product batch to all component lots used

Data Integrity Requirements

Regulators increasingly focus on data integrity (ALCOA+ principles):

• Attributable: Who performed the action and when
• Legible: Records must be readable and permanent
• Contemporaneous: Recorded at the time of the activity
• Original: First capture of data or verified copy
• Accurate: Free from errors and complete

How Trace Swift Supports Compliance

FDA 21 CFR Parts 210/211 Compliance

The FDA's Current Good Manufacturing Practice regulations for finished pharmaceuticals establish comprehensive requirements for manufacturing, processing, packing, and holding of drug products. Trace Swift supports the traceability and documentation requirements throughout Parts 210 and 211.

Subpart F - Production and Process Controls (§211.100-115)

Trace Swift helps you meet production documentation requirements:

• §211.100 Written procedures: Digital formula management with controlled procedures
• §211.101 Charge-in of components: Recording of each component lot and quantity added
• §211.103 Yield calculations: Actual vs theoretical yield tracking and variance analysis
• §211.105 Equipment identification: Batch records can include equipment notes

Subpart J - Records and Reports (§211.180-198)

Core documentation requirements supported by Trace Swift:

• §211.180 General requirements: Records maintained for required retention periods, readily available for inspection
• §211.182 Equipment records: Production records can include equipment notes
• §211.184 Component records: Complete traceability of each lot of components
• §211.186 Master production records: Digital formula management with specifications
• §211.188 Batch production records: Complete documentation of each batch produced
• §211.192 Production record review: Records organised for quality review and release

§211.188 Batch Production Record Requirements

The regulation requires batch production records to include:

• Product name, strength, and dosage form
• Unique batch number and batch size
• Complete formulation showing each component used
• Identity of each component lot and quantity added
• Dates and times of production steps
• Identification of persons performing each step
• In-process and laboratory test results
• Yield at appropriate phases
• Description of packaging and labelling
• Specimens of labels used

Trace Swift captures: product identification, batch numbers, formulations, component lot identity and quantities, production dates and timestamps, personnel attribution, and yield calculations. Laboratory test results and label specimens are typically managed in QC/LIMS and document control systems respectively.

EU GMP Compliance

EudraLex Volume 4 establishes GMP requirements for medicinal products manufactured or imported into the European Union. Trace Swift supports the documentation and traceability requirements throughout the EU GMP guidelines.

Chapter 4 - Documentation

EU GMP Chapter 4 establishes documentation requirements that Trace Swift supports:

• 4.17 Specifications: Document component and product specifications in formula records
• 4.18 Master formulae: Digital master production records with controlled revisions
• 4.19 Packaging instructions: Documented packaging specifications and procedures
• 4.20-4.22 Batch records: Complete batch production and packaging records
• 4.29 Retention: Records maintained for required retention periods

Annex 11 - Computerised Systems

For electronic records, Annex 11 requires:

• Audit trails: Complete tracking of data changes with user attribution
• Access controls: User authentication and role-based permissions
• Data integrity: Protection against unauthorised changes
• Backup and recovery: Data protection and business continuity

Purpose-Built for Pharmaceutical Manufacturing

Trace Swift understands the unique requirements of pharmaceutical manufacturing. Our platform supports manufacturers producing tablets, capsules, liquids, creams, and other dosage forms in GMP-regulated environments.

Pharmaceutical Manufacturing Scenarios

Component Categories We Support

Trace Swift handles the full range of pharmaceutical components:

• Active Pharmaceutical Ingredients: Track API lots with supplier batch codes, expiry, and retest dates
• Excipients: Manage fillers, binders, disintegrants, lubricants, and other inactive ingredients
• Packaging Components: Track bottles, closures, labels, and cartons with lot-level traceability
• Processing Aids: Track water, gases, and other processing materials
• Intermediates: Track in-process materials and bulk products before final packaging

Beyond Compliance: Business Benefits

While regulatory compliance is essential, Trace Swift delivers additional value to pharmaceutical manufacturing operations:

Accurate Cost Calculation

Know the true cost of every batch you manufacture. Trace Swift tracks actual component costs at the batch level. When raw material prices change, see immediately how your margins are affected. Essential for contract manufacturing pricing and tender submissions.

Formula Cost Optimisation

Compare component costs across approved suppliers. Identify opportunities to optimise formulations without compromising quality. Cost cascade calculations show how component changes affect finished product costs.

Inventory Control

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

Production Efficiency

Digital production capture eliminates manual data entry and transcription errors. Preparation summaries help plan production runs and warehouse picking. Mass balance calculations identify yield issues before they become problems.

Implementation Without Disruption

Unlike complex ERP systems requiring lengthy implementations and validation projects, Trace Swift is designed for practical deployment:

1. Day 1-2: Setup - Create your account, set up components, suppliers, and product formulas
2. Day 3-5: Go-Live - Start recording production batches alongside existing systems
3. Ongoing: Optimisation - UK-based email support helps you refine processes

Most pharmaceutical manufacturers achieve operational traceability within their first week. Trace Swift can operate alongside existing systems during transition periods, allowing gradual adoption without disrupting production.

Transparent, Affordable Pricing

Pharmaceutical 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 components, formulas, and batches
• Full GMP compliance capabilities
• Regular software updates and improvements
• Email support during UK business hours

Your Formulations Stay Confidential

Your pharmaceutical formulations represent significant R&D investment and intellectual property. Trace Swift treats them with the confidentiality they deserve:

• Strict multi-tenant architecture ensures complete data isolation
• Your formulations 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

Is Trace Swift validated for pharmaceutical use?

Trace Swift provides a platform that can be part of your validated environment, but the system is not pre-validated. You should assess Trace Swift against your computerised system validation requirements (per 21 CFR Part 11 or EU GMP Annex 11) and conduct appropriate qualification activities based on your risk assessment. Contact us to discuss your specific validation needs and what documentation we can provide.

Does Trace Swift work for small pharmaceutical manufacturers?

Yes. Trace Swift is designed for small to medium pharmaceutical manufacturers. Our pricing and functionality are tailored for businesses that need professional GMP compliance without enterprise complexity or cost. Whether you're producing 20 batches per month or 200, Trace Swift scales with you.

Will this help me pass an FDA inspection?

Trace Swift is designed to support FDA 21 CFR Parts 210/211 compliance, particularly the batch production record requirements of §211.188. We provide the traceability system, batch documentation, and component records that FDA inspectors expect to see. Digital records make inspections significantly less stressful than paper-based systems.

How does Trace Swift handle API potency and strength?

You can record potency and specification information in your component 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 expiry date management?

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

Can I manage contract manufacturing for multiple clients?

Yes. Trace Swift supports multiple product lines and can maintain separate formulas for different clients. Each batch is tracked independently with its own lot codes and traceability, while you maintain oversight of all production in one system. Client confidentiality is maintained through data isolation.

How long does a traceability trace take?

Most traces complete in under 5 minutes. You can identify all products containing a specific component lot, or all components in a specific batch, essentially instantly. This supports rapid response in recall situations and makes regulatory inspection responses straightforward.

Does Trace Swift support 21 CFR Part 11 compliance?

Trace Swift provides features that support Part 11 compliance including user authentication, audit trails, and electronic records. Full Part 11 compliance depends on how the system is implemented, validated, and controlled within your organisation. We recommend assessing the system against your Part 11 compliance requirements.