Common Pharmacy Findings

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

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

Why this matters

The same findings appear at pharmacy after pharmacy. Knowing the list is most of the defense, because almost all of them are preventable by a weekly habit.

The recurring list

Accountability does not reconcile. Usually because the log was written from memory rather than at the time.

Temperature records incomplete, or the monitoring device out of calibration.

Excursion handled without sponsor release, or released on a monitor's verbal assurance.

Delegation gaps. Someone dispensed before their delegation was signed, or a leaver is still on the access list.

Expired product on the usable shelf, unsegregated.

Returns mixed back into dispensable stock.

Destruction without written authorization.

Working from a superseded pharmacy manual.

No signature log, so initials on records cannot be attributed.

Most are weekly habits, not projects

Reconcile monthly. Check the expiry list weekly and segregate. Confirm the access list when anyone leaves. Check the manual version when a new one arrives. Keep the signature log current as staff join.

None of these takes long. All of them are findings when skipped for a year.

Findings cluster

A site with one of these usually has several, because they share a cause: records written later rather than at the time.

Fixing the habit fixes the cluster. Fixing each finding individually leaves the cause in place.

Responding to a finding

Understand it, agree what evidence closes it, set a date, do it, and show the evidence.

A response that argues rather than corrects extends the process and rarely changes the outcome.

In practice

A monitor notes that two initials on the accountability log cannot be attributed because there is no signature log.

You create one, have current staff sign it, and add a dated note for the two former staff identifying them from HR records. The finding closes at the next visit.

What this looks like when it goes wrong

A site receives the same accountability finding at three consecutive monitoring visits and corrects the specific entries each time.

The cause, that the log is written weekly rather than at the time, is never addressed. At inspection it becomes a systemic finding rather than a repeated minor one.

Key takeaways