Complete Batch Traceability from Raw Material to Dispatch

End-to-End Digital Batch Traceability for Indian Pharma

How Digital Batch Traceability Works

Digital batch traceability assigns a unique digital identity to every incoming raw material lot (API and excipients) at the point of receipt. From that moment, each movement and transformation of the material is recorded:

1. Goods Receipt & Labelling

• Each raw material lot is labelled with a barcode or QR code.
• The system records: supplier, COA details, receipt date/time, storage location, and initial QC status.
• This creates the starting point of the genealogy for that lot.

1. Weighing & Dispensing

• At the weighing station, operators scan the material label before dispensing.
• The system captures: operator ID, calibrated balance ID, target vs actual weight, time stamp, and any deviations.
• Partial lots and sub-lots are automatically tracked so every gram is accounted for.

1. Granulation, Blending, Compression, Coating

At each manufacturing step, the system links input materials and process parameters to the evolving batch:

• Operator identity (who performed/approved each step).
• Equipment used (granulator, blender, compression machine, coating pan, etc.).
• Environmental conditions (temperature, humidity, differential pressure where relevant).
• In-process controls (IPQC) such as blend uniformity, tablet weight, hardness, friability, moisture content.
• Any deviations, holds, or reworks are logged against the batch.

1. Packaging & Serialisation

• During primary and secondary packaging, the system associates each pack, carton, and shipper with its parent batch and sub-batch.
• Serialisation data (unique identifiers for packs/cartons) is generated and linked to the batch genealogy.
• Aggregation (pack → carton → shipper → pallet) is captured to support downstream track-and-trace.

1. Electronic Batch Record (EBR) & Genealogy

• All captured data forms a complete electronic batch record.
• Any finished product pack can be traced backwards to:
• Exact API and excipient lots used.
• Equipment and environmental conditions at each step.
• Operators and QC checks performed.
• Conversely, any raw material lot can be traced forward to all intermediate and finished batches it impacted.

This end-to-end digital chain replaces fragmented paper records with a single, searchable genealogy that can be queried in seconds.

Implementation Strategy for Indian Pharma Facilities

Boolean & Beyond deploys digital batch traceability across pharma plants in Bangalore, Coimbatore, Hyderabad, and other Indian hubs using a phased, integration-first approach:

1. Phase 1 – Goods Receipt & Labelling

• Introduce barcode/QR-code labelling at the warehouse.
• Integrate with existing ERP systems (SAP, Oracle, etc.) so material master, purchase orders, and GRNs flow automatically.
• Eliminate manual re-entry by using ERP as the system of record for commercial and inventory data, while the traceability layer manages genealogy.

1. Phase 2 – Weighing & Dispensing Integration

• Connect weighing stations to the traceability system.
• Auto-capture weights, material IDs, and operator logins.
• Enforce right-material, right-batch checks via barcode/QR scanning.

1. Phase 3 – Core Manufacturing Stages

• Extend coverage to granulation, blending, compression, coating, and related utilities.
• Integrate with LIMS for QC results so in-process and release tests are automatically linked to the batch.
• Implement electronic signatures and review-by-exception workflows.

1. Phase 4 – Packaging & Serialisation

• Connect packaging lines to generate and manage serial numbers.
• Capture aggregation hierarchies and link them to batch genealogy.
• Align with India’s track-and-trace requirements and export market mandates.

1. Timeline

• A typical deployment for a single production facility completes in 12–16 weeks, including:
• Site assessment and URS finalisation.
• System configuration and integration with ERP/LIMS.
• Validation (IQ/OQ/PQ) and user training.
• Go-live with hypercare support.

Recall Readiness & Regulatory Benefits

Digital batch traceability significantly strengthens recall management and regulatory compliance:

1. Narrow, Targeted Recalls

• Instead of recalling all production over a date range, you can identify only those batches that used a specific suspect raw material lot or were processed on a particular line or shift.
• This reduces product destruction, logistics costs, and market disruption.

1. Faster Investigations

• Pharmaceutical manufacturers using Boolean & Beyond’s systems report recall investigation time dropping from 2–3 weeks to under 4 hours.
• Root cause analysis is accelerated by correlating:
• Material lots.
• Equipment and environmental data.
• In-process and release test results.
• Deviations and change controls.

1. Regulatory Alignment

• The system generates and manages serialisation data required under India’s track-and-trace mandate.
• Supports compliance for export markets including:
• US DSCSA (Drug Supply Chain Security Act).
• EU FMD (Falsified Medicines Directive).
• DRAP requirements for relevant markets.
• Electronic records and signatures support data integrity expectations (ALCOA+) from regulators.

ROI & Operational Improvements

Beyond compliance, digital traceability delivers tangible business value:

1. Faster Batch Release

• 40–60% reduction in batch release cycle time.
• QA reviews complete, consistent electronic batch records instead of chasing paper, missing signatures, or manual logbooks.

1. Inventory Accuracy & Control

• Real-time tracking of material movements and consumption drives 99%+ inventory accuracy.
• Reduces stock-outs, overstocking, and write-offs due to mislabelled or untraceable materials.

1. Yield & Process Optimisation

• Granular yield analysis links batch performance to:
• Specific raw material lots and suppliers.
• Equipment and line configurations.
• Environmental conditions and shift patterns.
• This enables data-driven process improvements and supplier quality management.

1. Reduced Rejections & Deviations

• Facilities in Bengaluru’s pharmaceutical corridor have seen 25–35% reductions in batch rejection rates within the first year.
• Better visibility and enforcement of process parameters reduce human error and variability.

1. Lower Compliance Overhead

• Automated documentation, audit trails, and reporting reduce manual effort for inspections and regulatory submissions.
• Review-by-exception allows QA and QC teams to focus on true risk areas.

In summary, a well-implemented digital batch traceability system in Indian pharma plants provides end-to-end material genealogy, accelerates recalls and investigations, ensures compliance with domestic and export regulations, and delivers rapid, measurable improvements in release timelines, inventory accuracy, and batch quality.