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Compliance

What drug inspectors check during a pharmacy audit

Expiry records, disposal logs, batch documentation — here's what to have ready before an inspection.

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ABIN RAJ K · 10 May 2025 · 5 min read

A drug inspector visit is one of the most stressful events for a pharmacy. Most pharmacies that fail audits don't fail because they're doing something wrong — they fail because their records aren't organized and ready. Here's exactly what inspectors look for.

Expiry date records

The first thing any inspector checks is whether your pharmacy has a system for tracking expiry dates. They want to see that you know which medicines are expiring in the next 30, 60, and 90 days, that expired medicines are physically separated from active stock, and that you haven't dispensed expired medicines.

Batch-level documentation

Inspectors trace medicines back to their source. For every medicine in your stock, they expect to find the batch number, manufacturer or distributor name, and date received. If a recalled medicine comes up, batch-level records are how you prove whether that batch is or is not in your stock.

Disposal logs

When medicines expire, where do they go? Inspectors want a paper trail. Proper disposal documentation includes which medicines were disposed of, the quantity, the date, who authorized the disposal, and the disposal method — returned to supplier or destroyed. Without disposal logs, you have no way to prove expired medicines were properly handled.

Storage conditions

Temperature-sensitive medicines — insulin, certain vaccines, biologics — require documented storage conditions. If you hold any temperature-sensitive stock, be ready to show temperature logs for your cold storage units.

Prescription records

For Schedule H and H1 medicines, inspectors verify that your prescription records match your dispensing records. Every controlled medicine dispensed should have a corresponding prescription on file.

How MedExpiry helps with audit readiness

MedExpiry keeps your expiry records, batch documentation, and disposal logs organized and exportable at any time. Before an inspection, export your current non-expired inventory as a date-filtered CSV, export your expired medicines list showing dates and batch numbers, and pull your disposal log from the Enterprise dashboard. Everything is timestamped and ready for inspection submission.

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