Generate an Excel/PDF workbook for pharmaceutical internal audit: licences, GMP documents, BMR/BPR, QC release, batch-wise inventory, expiry, samples, distributor schemes, NPPA pricing, cold chain, calibration and ERP/LIMS/QMS controls.
| Area | Risk | Control | Test | Evidence | Cadence |
|---|---|---|---|---|---|
| Licences product master | Manufacturing, loan licence, product approval, labelling, price-control or renewal records are incomplete, expired or not mapped to live SKUs. | Licence tracker, SKU-regulatory master mapping, renewal escalation and change-control approval. | Match live SKU master to licence and product approval files; check renewals, notices, labels and regulatory master changes. | Manufacturing licence, product permission, SKU master, label approval, renewal tracker, notice file and change-control record. | Monthly / Renewal cycle |
| GMP SOP QMS | SOPs, deviations, CAPA, complaints, recalls, change controls or training records do not support the quality system. | Document control, deviation/CAPA review, complaint and recall escalation, GMP training tracker. | Sample SOP version control and training; age deviations and CAPA closures; review complaint and recall logs. | SOP register, training records, deviation log, CAPA tracker, complaint/recall file and quality review sign-off. | Monthly / Quarterly |
| Batch records production | BMR/BPR entries, line clearance, yields, reprocessing, batch reconciliation or supervisor approvals are incomplete or inconsistent with ERP stock movement. | Approved BOM/process sheet, BMR/BPR review, line clearance, yield and reconciliation approval. | Trace batches from plan to BMR/BPR and ERP issue/receipt; compare yield to standard; review rework and QA release. | Batch plan, BMR, BPR, BOM, material issue, production receipt, yield reconciliation, deviation and QA release. | Batch-wise / Monthly |
| RM PM QC release | Raw material and packing material receipt, quarantine, sampling, QC release, rejection, retest or vendor qualification is unsupported. | Approved vendor list, GRN quarantine control, QC sampling/release, retest and rejection review. | Match GRN to PO, COA, quarantine and QC release; test rejected/expired material and vendor qualification. | PO, GRN, COA, quarantine label, QC report, release note, rejection note, retest list and vendor file. | Receipt-wise / Monthly |
| Inventory expiry stock count | Batch-wise stock, expiry, near-expiry, rejected goods, samples or slow-moving material are misstated or physically unavailable. | Batch-wise inventory ledger, FEFO issue control, expiry ageing review and stock count reconciliation. | Perform batch-wise count, age near-expiry and slow-moving stock, review write-off/destruction and trace samples/free goods. | Batch stock ledger, expiry report, count sheet, variance approval, destruction certificate and sample register. | Monthly / Count cycle |
| Sales returns schemes | Primary sales, samples, free goods, distributor schemes, sales returns, expiry claims and credit notes are misstated or override controls. | Scheme approval, credit-note matrix, sample/free-goods register and return/expiry claim review. | Match invoices to dispatch and distributor ledger; review credit notes; test samples/free goods and returns to stock movement. | Invoice, dispatch proof, distributor ledger, scheme circular, credit note, sample register, return note and expiry claim. | Monthly |
| Pricing MRP NPPA | Scheduled formulation ceiling prices, retail prices, MRP changes, price lists or non-scheduled annual increase controls are not monitored. | Price master maker-checker, DPCO/NLEM applicability review, MRP approval and NPPA order tracker. | Compare selected SKUs to approved price master and NPPA/DPCO evidence; review MRP changes, price lists and notices. | Price master, NPPA order or DPCO support, NLEM mapping, MRP approval, price list, invoice and notice tracker. | Monthly / Price change |
| Cold chain logistics | Temperature-sensitive inventory, dispatches, PODs, cold-chain logs or transporter claims are not supported by reliable evidence. | Temperature log review, transporter qualification, dispatch/POD reconciliation and excursion escalation. | Review temperature logs and excursions; match dispatch to invoice, e-way bill and POD; test returns and rejected deliveries. | Temperature log, excursion report, dispatch note, e-way bill, POD, transporter contract, return note and claim file. | Daily / Monthly |
| Calibration validation EHS | Equipment calibration, preventive maintenance, process validation, cleaning validation, utilities or EHS records are overdue or unsupported. | Calibration schedule, preventive maintenance plan, validation protocol approval and EHS incident escalation. | Age overdue calibration and maintenance; sample validation protocols/reports; review breakdown impact and EHS incidents. | Calibration certificate, PM log, breakdown record, validation protocol/report, utility log, EHS register and inspection evidence. | Monthly / Validation cycle |
| ERP LIMS QMS access | Users can change BOM, batch status, QC release, price master, credit notes or regulatory master data without review. | Role-based access, leaver review, master-change approval and audit-log monitoring. | Review privileged users, leavers, shared IDs, master changes, audit logs and interface exceptions. | User list, role matrix, HR exit list, master-change log, audit log, interface exception report and access review. | Monthly / Quarterly |
Use this with the pharma internal audit checklist, the RCM builder and the monitoring rules repository.
Pharma internal audit is strongest when quality records, production records, inventory records and financial records are tested together. The workbook connects licences, GMP documentation, BMR/BPR, QC release, batch-wise inventory, expiry, sales returns, samples, pricing, cold chain, calibration and access controls into one fieldwork file.
The Excel export gives auditors separate sheets for engagement scope, RCM rows, batch-record testing, QC release and inventory, pricing/sales/claims, compliance/access and monitoring exceptions. Tailor it to formulation manufacturing, API, loan licence, contract manufacturing, warehouse or marketing operations.
A CA firm is reviewing a formulation manufacturer with production, QC, warehouse, distributor billing, samples, credit notes and price-master controls.
