The Pharmacy File and Version Control

Part of Trial Pharmacy (PHARM) Training: Pharmacy Documentation.

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

Why this matters

An inspector or monitor asks for the pharmacy file as a unit. Its completeness is assessed before its contents are read.

A file assembled from four locations during a visit has already made an impression.

What the file usually holds

The current pharmacy manual and protocol sections relevant to pharmacy. Delegation and training records for pharmacy staff, with CVs. Receipt records. Temperature logs and calibration certificates. Accountability logs. Dispensing records and preparation worksheets. Returns and destruction records. Randomization and unblinding documentation. Correspondence on product questions, including excursion decisions.

Check the sponsor's own index if one is provided.

Version control

Superseded versions of the manual and protocol are archived, not left in the working file.

Working from a superseded pharmacy manual is a deviation that can repeat for months undetected, because nobody checks a document they have used for a year.

Mark the current version clearly. Archive rather than destroy, because you may need to show what you were working from on a given date.

Correspondence is part of the record

An email from the sponsor releasing quarantined stock is the authorization for every dispensing that followed.

File it. A decision remembered but not filed cannot be shown, and the dispensings it authorized become unsupported.

Keep it current, not tidy

The file is updated as things happen. A file brought up to date before a visit is a file whose dates cluster, and that is visible.

Ten minutes weekly costs less than a day before a monitoring visit and produces a better record.

In practice

The sponsor issues pharmacy manual version 4. You print it, mark it current, move version 3 to the archive section with the date superseded, and confirm every pharmacy staff member knows.

You then check whether anything in version 4 changes a process in use today.

What this looks like when it goes wrong

A pharmacy keeps three versions of the manual in the same folder, none marked current.

A technician follows version 2 preparation instructions for four months. Every dose in that period was prepared against a superseded document, and the deviation covers dozens of participants.

Key takeaways