Storage, Monitoring and Access

Part of Trial Pharmacy (PHARM) Training: Receipt and Storage.

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

Why this matters

Storage conditions are part of the product specification. A drug stored outside its range may not be the drug the protocol describes.

Monitoring is what lets you prove it was stored correctly, and access control is what lets you prove nobody else touched it.

Continuous monitoring, not spot checks

A reading taken twice a day tells you about two moments. Continuous monitoring with minimum and maximum capture tells you about the whole period.

Most protocols require the latter. Know which you have, and know its calibration date.

An uncalibrated monitor produces numbers that cannot be defended.

Alarms need a responder

An alarm that sounds in an empty building at two in the morning protects nothing.

Know who responds out of hours, how they are contacted, and what they are meant to do. Ask before you need it, and confirm the phone number is current.

This is the single most common gap in pharmacy storage arrangements.

Access

Investigational product is stored with restricted access, separate from routine stock.

Separation prevents the most ordinary error there is: a busy colleague taking a box that looks like something else. A locked cupboard or fridge with a documented key holder list is the usual arrangement.

Review the list when staff leave. A departed employee on an access list is a finding.

Daily checks

Even with continuous monitoring, a daily documented check confirms the system is working and that someone looked.

Record the reading, the minimum and maximum since the last check, your initials and the date. Reset the min and max after recording, if the device requires it.

In practice

The fridge display shows a minimum of 1.8C overnight, below the 2C limit.

You do not reset and move on. You quarantine the affected stock, record the duration and the temperature reached, and escalate to the sponsor with the logger data.

Small excursions still need a stability decision, and that decision is not yours.

What this looks like when it goes wrong

A pharmacy records daily temperatures as "within range" without noting values. A monitor asks for evidence that stock was stored correctly during a specific week.

The log shows ticks. It cannot show what the temperature actually was, so the site cannot demonstrate compliance for any of the product dispensed that month.

Key takeaways