What Does an MHRA Inspector Look For in a Pharmacy Site File?
An MHRA inspector looks in a pharmacy site file for evidence that the site can rebuild the history of any unit of investigational medicinal product on demand. This guide covers the notification and dossier, what is requested and in what order, the walkthrough, the single unit trace and how findings are graded.
Who Releases IMP to a UK Site, and What Is QP Release?
A Qualified Person releases an IMP batch by certifying it, and the sponsor releases that stock to a named site. This guide covers QP certification, the MIA(IMP) behind it, how an imported product reaches a UK site, the green light to dispense, and which release documents a pharmacy files.
IMP Labelling Requirements for UK Trials
IMP labelling requirements for UK trials are set by regulation 46 of the Clinical Trials Regulations, as amended from 28 April 2026. This guide covers the particulars a full label must show, which labelling set applies to which product, who may apply or change a label, and expiry extension at site.
Blinding in the Pharmacy: Keeping the Secret and Breaking It in an Emergency
Blinding in the pharmacy means holding the treatment allocation out of reach of the trial team, and releasing it for one participant when a clinical emergency requires it. This guide covers who may know what is inside a kit, what ICH E6(R3) section 2.11 requires, how a code break runs, and what is recorded.
Delegation and Training: Why Who Did It Matters as Much as What Was Done
A pharmacy record entry counts as evidence when the person who made it was delegated that activity and trained for it on the day. This guide covers the authorised-and-trained condition, what a delegation log records, which activities need documenting, training currency, and what an inspector asks.
What Does ICH E6(R3) Require of IMP Management at the Site?
ICH E6(R3) requires the investigator or institution to hold responsibility for IMP management at the site, and section 2.10 sets that duty out in nine clauses. This guide takes each clause as it applies at a UK site, the conditions on delegating to a pharmacist, and where the sponsor’s duty begins.
IMP vs NIMP: Which Products Need Trial-Grade Records?
An investigational medicinal product needs a trial-grade record, and a non-investigational medicinal product needs the record its protocol specifies. This guide covers who fixes each product’s class, the record each class attracts at a UK site, and how a misclassification breaks the pharmacy log.
Why the Hospital Pharmacy Stock System Is Not a Trial Record
A hospital pharmacy stock system is built to control the trust’s inventory, and a trial record has to account for each numbered unit against a participant. This guide covers what a stock system evidences, the per-participant and audit trail gaps, and how a site holds both records without drift.
Paper Accountability Logs vs an Electronic Pharmacy Record
A paper accountability log and an electronic pharmacy record hold the same facts about the same units of IMP. This guide compares them on where errors enter, how a correction is made, what a retrospective reconciliation costs, the storage and retrieval effort, and the monitoring effort.
RTSM and IRT vs the Pharmacy Record: Which Holds What?
An RTSM or IRT system holds the sponsor’s randomisation, kit allocation and study-wide supply position. The site pharmacy record holds custody of the units that arrived and what pharmacy did with each. This guide covers what each owns, the four handover points, and why a site keeps its own ledger.
