Batch and lot tracking with expiry, GMP-ready BMRs, raw material traceability, supplier COA, multi-stage QC and regulatory documents for CDSCO, US FDA, WHO and EU-GMP audits. ERPDrive is built for Indian formulation plants, API units and contract manufacturers.
Every finished tablet, capsule, syrup or injection that leaves your plant carries the full history of its APIs, excipients, water system, operators, equipment and environmental conditions. Regulators can arrive any week and ask you to prove that Batch XYZ made on 12 November 2025 used the specific API lot from a qualified supplier, was compressed on a calibrated machine, passed in-process checks, and was stored under controlled conditions. If any of that history lives in paper registers or disconnected Excel files, you are one question away from a serious finding.
ERPDrive gives formulation plants, API units, nutraceutical makers and contract manufacturers a single system that captures this evidence as the plant runs. Raw materials arrive with a supplier COA and a batch number. They move into the approved store only after incoming QC. When a production order kicks off, the system issues material in FEFO order, opens an electronic BMR, logs each in-process check, and records packaging details right up to the cartoning stage. The finished batch carries its own number, manufacturing date, expiry date and quality release status, which then drives dispatch, customer invoicing and any future recall.
The result is audit readiness by default. Site master files, batch records, deviation logs, change controls, annual product reviews and stability summaries are generated from live data, not rebuilt the night before an inspection.
Every feature is designed for the realities of Indian pharma manufacturing.
Every raw material, intermediate and finished good carries a system-generated batch number with manufacturing date, expiry date, vendor batch reference, quality status and storage condition. FEFO dispensing is enforced automatically. Expired or near-expiry stock is blocked from issue. A full genealogy view shows every consumption and transfer of a batch.
Batch Manufacturing Records and Batch Packaging Records open automatically when a production order starts. Operators sign off each step, including area clearance, line clearance, granulation yield, compression parameters, coating weight gain and packaging counts. The signed record ties to the physical batch and is available for regulatory download on demand.
Incoming QC for APIs and excipients, in-process checks after granulation, compression, coating, filling and packaging, final release testing, and retained sample management are all native. Each stage captures analytical results, microbial counts, physical parameters and visual inspection against product specifications.
Incoming batches link to supplier Certificates of Analysis. Vendors are qualified with valid GMP, ISO and regulatory certificates stored against the master. Certificate expiry and failed inspections downgrade a vendor automatically, preventing non-compliant inputs from entering the plant.
A single screen shows the full genealogy of a finished pack: every API lot, excipient lot, solvent drum, primary packaging roll, secondary carton and operator sign-off. Recall scenarios that used to take days now take minutes, because every consumption is recorded at the batch level as production runs.
Annual Product Review, Product Quality Review, Site Master File, Stability Summary, Deviation Log, Change Control Register, CAPA and Customer Complaint registers are all generated from live transactional data. Auditors from CDSCO, US FDA, WHO, EU-GMP and TGA see system-generated evidence, not retrofitted paper.
From API receipt to finished dispatch, every step captures the evidence regulators want.
A tanker of paracetamol arrives with a supplier COA. GRN creates a new batch number, links the COA, and parks the material in quarantine. The QC analyst samples as per the approved plan, records assay, LOD, heavy metals and related substances. On pass, status changes to approved and the batch moves to the raw material store.
A production order for 500,000 tablets of Product X opens an electronic BMR. Dispensing issues API and excipient batches in FEFO order, with weighing captured directly from connected balances where available. Area clearance, line clearance and operator training validity are verified before granulation starts.
After granulation, moisture and bulk density are logged. After compression, tablet weight, hardness, thickness, friability and disintegration time are captured every hour. After coating, weight gain per batch is recorded. Any out-of-specification result triggers a deviation and holds the batch until closure.
Blister, bottle, carton and shipper counts are reconciled against BMR. The finished batch receives a unique number with manufacturing and expiry dates. QC runs release testing, signs off the Certificate of Analysis and moves stock from quarantine to finished goods store ready for dispatch.
Sales orders pick finished batches under FEFO, with buffer expiry control by customer and market. A retained sample is logged to stability. If a recall is ever needed, the genealogy and dispatch register combine to list every customer, location and quantity shipped within minutes.
Common questions from pharma manufacturers evaluating ERPDrive.
Every raw material, in-process material and finished product in ERPDrive carries a batch or lot number with manufacturing date, expiry date, vendor batch reference and quality status. The system enforces FEFO dispensing, blocks expired stock from production and dispatch, and traces any finished batch back to the exact API, excipient and packaging lots that went into it. A single-click genealogy report satisfies regulatory recall queries and internal deviation investigations.
ERPDrive is built with Schedule M and WHO GMP principles in mind. It supports electronic batch manufacturing records, signed and versioned standard operating procedures, BMR and BPR linked to every production order, equipment calibration and cleaning logs, area clearance checks and deviation records. Audit trails are immutable and every record has user, timestamp and reason captured, which aligns with 21 CFR Part 11 style expectations for electronic records.
Yes. Every incoming material batch can be linked to a supplier Certificate of Analysis, a sampling plan and a quality inspection result. Vendors are qualified through approved vendor lists with valid GMP, ISO and regulatory certificates stored against the vendor master. Expiry of certificates triggers alerts, and a vendor who fails to provide COA or fails inspections is automatically downgraded in the approved list, protecting your plant from non-compliant inputs.
ERPDrive runs multi-stage QC designed for pharma: incoming quality control for APIs and excipients, in-process checks after granulation, compression, coating and packaging, and final release testing before dispatch. Each stage captures analytical results, stability data, microbial limits and visual inspection against specifications. Only batches that pass every stage can move forward, and rejected batches route automatically to the quarantine store with a deviation log.
Every batch carries an expiry date captured at goods receipt or during production. ERPDrive applies FEFO logic during material issuance, sales order picking and dispatch, so shorter-expiry stock moves first. Buffer periods before expiry can be configured to block near-expiry stock from going to customers who insist on minimum shelf life. Short-expiry reports alert managers weeks in advance, enabling sale on discount, alternate use or scrapping with proper regulatory destruction records.
Yes. ERPDrive produces site master files, BMRs, BPRs, product quality reviews, stability summaries, deviation logs, change control records and annual product reviews that auditors from CDSCO, US FDA, WHO, EU-GMP and TGA commonly request. Because every document is system-generated from underlying data and carries an audit trail, regulators can see that the document matches the actual event, not a back-dated paper copy. This dramatically reduces audit preparation time.
See how ERPDrive gives your formulation plant or API unit batch traceability, GMP-ready BMRs, COA workflows and regulatory documents, all in one system. Book a free 30-minute pharma-focused demo.
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