Licences, product master and regulatory file
Risk: Manufacturing, loan licence, product approval, labelling, price-control or renewal records are incomplete, expired or not mapped to live SKUs.
Controls
- Licence tracker
- SKU-regulatory master mapping
- Renewal escalation
- Change-control approval
Tests
- Match live SKU master to licence and product approval files
- Check renewal dates and open notices
- Review label/MRP control evidence
- Trace regulatory changes to approved master updates
Evidence
Manufacturing licence, product permission, SKU master, label approval, renewal tracker, notice file and change-control record.
GMP documentation, SOPs and quality system
Risk: SOPs, deviations, CAPA, complaints, recalls, change controls or training records do not support the quality system relied on by operations.
Controls
- Document control
- Deviation and CAPA review
- Complaint/recall escalation
- GMP training tracker
Tests
- Sample SOP version control and training acknowledgement
- Age deviations and CAPA closures
- Review complaint and recall logs
- Check quality-review sign-offs
Evidence
SOP register, training records, deviation log, CAPA tracker, complaint/recall file, quality review and management sign-off.
Batch manufacturing and packing records
Risk: BMR/BPR entries, line clearance, yields, reprocessing, batch reconciliation or supervisor approvals are incomplete or inconsistent with ERP stock movement.
Controls
- Approved BOM and process sheet
- BMR/BPR review
- Line clearance
- Yield and reconciliation approval
Tests
- Trace selected batches from plan to BMR/BPR and ERP issue/receipt
- Compare actual yield to standard
- Review rework/reprocessing approvals
- Check batch closure and QA release
Evidence
Batch plan, BMR, BPR, BOM, material issue slip, production receipt, yield reconciliation, deviation note and QA release.
Raw material, packing material and QC release
Risk: RM/PM receipts, quarantine, sampling, QC release, rejection, retest or vendor qualification records do not support material use in production.
Controls
- Approved vendor list
- GRN quarantine control
- QC sampling/release
- Retest and rejection review
Tests
- Match GRN to PO, COA, quarantine and QC release
- Test rejected/expired material movement
- Review vendor qualification files
- Check retest-date blocks before issue
Evidence
PO, GRN, COA, quarantine label, QC report, release note, rejection note, retest list and vendor qualification file.
Inventory, expiry, slow-moving and stock count
Risk: Batch-wise stock, expiry, near-expiry, rejected goods, samples or slow-moving material are misstated or physically unavailable.
Controls
- Batch-wise inventory ledger
- FEFO issue control
- Expiry ageing review
- Stock count reconciliation
Tests
- Perform batch-wise count for selected RM/PM/FG
- Age near-expiry and slow-moving stock
- Review write-off/destruction approvals
- Trace samples and free goods movement
Evidence
Batch stock ledger, expiry report, count sheet, variance approval, destruction certificate, sample register and slow-moving provision.
Sales, distributor schemes, samples and credit notes
Risk: Primary sales, institutional sales, free goods, samples, schemes, returns, expiries and credit notes are misstated or used to override commercial controls.
Controls
- Scheme approval
- Credit-note approval matrix
- Sample/free-goods register
- Return and expiry claim review
Tests
- Match invoices to dispatch and distributor ledger
- Review credit notes by reason/user/distributor
- Test sample/free-goods approvals
- Trace sales returns and expiry claims to stock movement
Evidence
Invoice, dispatch proof, distributor ledger, scheme circular, credit note, sample register, return note, expiry claim and stock adjustment.
Pricing, MRP and NPPA/DPCO compliance evidence
Risk: Scheduled formulation ceiling prices, retail prices, MRP changes, price lists or non-scheduled annual increase controls are not monitored.
Controls
- Price master maker-checker
- DPCO/NLEM applicability review
- MRP change approval
- NPPA order tracker
Tests
- Compare selected SKUs to approved price master and current NPPA/DPCO evidence
- Review MRP change approvals
- Test distributor price lists
- Check overcharge notice/action files
Evidence
Price master, NPPA order or DPCO support, NLEM mapping, MRP approval, price list, invoice sample and notice/action tracker.
Cold chain, warehouse and logistics
Risk: Temperature-sensitive inventory, dispatches, PODs, cold-chain logs or transporter claims are not supported by reliable evidence.
Controls
- Temperature log review
- Transporter qualification
- Dispatch/POD reconciliation
- Excursion escalation
Tests
- Review temperature logs and excursions
- Match dispatch to invoice, e-way bill and POD
- Test cold-chain transporter bills
- Check rejected delivery and return controls
Evidence
Temperature log, excursion report, dispatch note, e-way bill, POD, transporter contract, return note and claim file.
Engineering, calibration, validation and EHS
Risk: Equipment calibration, preventive maintenance, process validation, cleaning validation, utilities or EHS records are overdue or unsupported.
Controls
- Calibration schedule
- Preventive maintenance plan
- Validation protocol approval
- EHS incident escalation
Tests
- Age overdue calibration and maintenance
- Sample validation protocols/reports
- Review breakdown impact on batches
- Check EHS incidents and statutory inspections
Evidence
Calibration certificate, PM log, breakdown record, validation protocol/report, utility log, EHS register and inspection evidence.
ERP, LIMS, QMS and access controls
Risk: Users can change BOM, batch status, QC release, price master, credit notes or regulatory master data without review.
Controls
- Role-based access
- Leaver review
- Master-change approval
- Audit-log monitoring
Tests
- Review privileged ERP/LIMS/QMS users
- Test leaver and shared IDs
- Sample BOM, price, QC release and batch-status changes
- Review interface and audit-log exceptions
Evidence
User list, role matrix, HR exit list, master-change log, audit log, interface exception report and access review sign-off.
