1. Purpose

To ensure investigational product is received, stored, prepared, dispensed, reconciled and returned or destroyed under controlled conditions with complete accountability, including management of temperature excursions.

2. Scope

Applies to all investigational products, comparators, placebos and ancillary study supplies handled by the Investigational Pharmacy or by clinical staff under pharmacy oversight.

3. Responsibilities

• Investigational Pharmacy Manager: Owns storage conditions, accountability records, and excursion management.
• Research Pharmacist: Verifies prescriptions against the protocol, prepares and dispenses product, and documents each transaction.
• Pharmacy Technicians: Receive shipments, record temperatures, and maintain inventory under pharmacist supervision.
• Principal Investigator: Retains responsibility for product accountability and may delegate day-to-day handling to the pharmacy.

4. Definitions

Investigational product (IP)

A pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial.

Temperature excursion

Any recorded temperature outside the labelled storage range for the product, for any duration.

Accountability log

The record of every unit of product received, dispensed, returned, destroyed or in inventory, reconciling to zero discrepancy.

Quarantine

Physical or electronic segregation of product that must not be dispensed pending a use decision.

5. Procedure

1. Receive shipments only into the designated investigational pharmacy area; verify the shipment against the packing list for product, quantity, lot, expiry and kit numbers within one business day.
2. Inspect and record the in-transit temperature monitor reading at receipt; if the monitor indicates an excursion, quarantine the shipment immediately and do not dispense.
3. Acknowledge receipt in the sponsor's interactive response system within the required interval and file the packing list in the pharmacy study file.
4. Store product in the assigned, access-controlled location within its labelled temperature range, segregated by study and never mixed with commercial stock.
5. Monitor storage temperature continuously with a calibrated, alarmed device; record minimum and maximum temperatures each business day and retain the electronic log.
6. Maintain calibration certificates for all temperature monitoring devices and verify calibration at least annually.
7. On any excursion, quarantine the affected product, record the duration and the minimum and maximum temperatures reached, notify the sponsor within one business day, and dispense only after written sponsor authorisation.
8. Verify every dispensing request against the protocol, the subject's randomisation assignment, dose level and visit window before preparation.
9. Prepare product according to the pharmacy manual, using a second-person verification for dose calculations and for any blinded preparation.
10. Record each dispensing transaction in the accountability log with date, subject identifier, kit or bottle number, quantity, lot, expiry, dispenser and verifier.
11. Maintain blinding at all times; keep emergency unblinding procedures documented and accessible, and record any unblinding event with date, time, reason and authoriser.
12. Collect and document returned product and unused units, recording the quantity returned and any compliance findings for the subject.
13. Reconcile the accountability log against physical inventory monthly and at every monitoring visit, investigating and documenting any discrepancy before close-out.
14. Return or destroy product only with written sponsor authorisation, using an approved destruction method, and file the destruction or return certificate in the study file.
15. Retain all pharmacy records, temperature logs, calibration certificates and destruction records for the retention period in DAT-003.

6. References

• 21 CFR Part 312.57 — Recordkeeping and record retention (sponsors)
• 21 CFR Part 312.62 — Investigator recordkeeping and record retention
• ICH E6(R3) Good Clinical Practice, investigational product management
• REG-001 Regulatory Binder / Essential Documents Maintenance
• DAT-003 Study Close-Out & Record Retention

7. Revision History

• v3.0 · Oct 02, 2023 — Added continuous alarmed monitoring and calibration requirements.
• v4.0 · Jan 26, 2026 — Expanded excursion quarantine workflow and second-person verification.