What an Inspector Asks a Pharmacist

Part of Trial Pharmacy (PHARM) Training: Inspection Readiness.

About 2 minutes. Free, in your language, no account needed.

Why this matters

Regulatory inspections reach the pharmacy, and they reach the pharmacist rather than only the file.

Good work recorded well is easy to show. The loss comes from not knowing where things are.

What they usually ask

Show me this participant's dispensing, end to end. Prescription, allocation, preparation worksheet, dispensing record, accountability entry.

Reconcile this product for me. Received, dispensed, returned, destroyed, remaining.

Who is delegated for pharmacy tasks, and since when?

Show me the temperature record for this period, and the calibration certificate.

What happened with this excursion? The data, the report, the sponsor release.

Which version of the pharmacy manual are you working from?

How to answer

Answer the question asked. Do not tour the file.

If you do not know, say so and say who does. Do not speculate about why something is missing.

Bring the document rather than describing it.

The four habits that make it easy

Can you find the current pharmacy manual version in under a minute? Does the reconciliation balance today? Is the calibration certificate in date? Is the delegation log current, including leavers removed?

If those four are yes, an inspection is a conversation.

Do not prepare by back-filling

Signing, dating and completing records shortly before an inspection is detectable and converts an administrative finding into a question about whether the records can be believed.

The right preparation is having done the work, and knowing where it is.

In practice

An inspector asks to reconcile one product. You show the accountability log with its running balance, the receipt records, the dispensing entries, the returns and the destruction certificate, and the balance closes.

That takes five minutes when the log was kept at the time, and half a day when it was not.

What this looks like when it goes wrong

A site completes its temperature log for three missing weeks the evening before an inspection, from memory and a data logger.

The entries are in consistent ink, written in one sitting, for a period the logger shows the fridge was opened many times. The finding is no longer about missing readings.

Key takeaways