Choosing a depot is one of the quieter decisions in a clinical program, and one of the most consequential. Once investigational product sits in a local warehouse, its quality depends on systems the sponsor does not run day to day. A qualification visit or audit is the chance to check those systems properly. The points below form a practical checklist, using GeoStorage, a GDP-certified depot in Tbilisi, Georgia, as a working example.
1. Licenses and certificates that match the market
Start with the paperwork, because nothing else counts without it. A depot handling pharmaceuticals should hold the GDP license its country requires, a pharmaceutical wholesale license where applicable, and a quality management system certified to ISO 9001. An EU GDP certificate shows that the depot also meets European expectations.
In Georgia, GDP became mandatory in 2022. GeoStorage was approved under the local framework that year, has been certified by SGS against the EU GDP Guidelines since 2018 and has run ISO 9001 since 2014. Ask to see the current certificates, not just the logos on a website.
2. Validated zones for the actual product
Good temperature controlled storage is defined by validated zones, not by the number of refrigerators. A depot should show temperature mapping for each zone and explain how often the mapping is repeated. GeoStorage stores product at +15 to +25 °C, +2 to +8 °C, -20 to -35 °C and down to -80 °C, with liquid-nitrogen storage down to -197 °C.
Keep storage and transport apart in the discussion. A depot may store at one range and ship at another. GeoStorage, for example, ships on dry ice at -86 °C, which is a transport condition, not a storage zone. Mixing the two up is a common source of errors in supply plans.
3. Monitoring that reaches a person
Continuous logging is standard. The real test is what happens at 3 a.m. when a freezer starts to drift. Ask who receives the alarm, how quickly they respond, and how excursions are documented and reported to the sponsor. GeoStorage logs temperature and humidity 24/7, sends instant SMS alerts and keeps backup power on site.
4. Physical and data security
Stock is also exposed to power cuts, intrusion and fire, and monitoring data to IT failures. Check access control, alarm response time, fire protection and data backup. GeoStorage’s security and monitoring systems include key card entry, an alarm system with a five-minute response time, instant fire alerts and cloud data backup, and the company holds ISO/IEC 27001:2022 certification for information security.
5. Audit history
A depot’s audit record is the most honest summary of its quality system. Ask how many sponsor and third-party audits it has hosted and what they found. GeoStorage has hosted 102+ partner and third-party audits, and none produced a major or critical finding.
6. Handling beyond storage
Clinical supply rarely sits still. Protocol amendments bring label changes, and studies end with returns, reconciliation and destruction. Confirm which labeling work the depot is authorized to do, and that it can manage returns and recalls and carry out certified destruction with full documentation. GeoStorage places approved additional labels on existing packaging under written sponsor instructions and archives study documents.
7. The border and the last mile
Storage is only half of the chain. Ask how product reaches the sites, in what packaging and with which data loggers, and who handles import. As a GDP-certified depot and forwarder, GeoStorage’s customs team works on behalf of the authorized CRO, clears clinical supplies through customs at the Tbilisi airport in 24 to 48 hours, and delivers to sites in Tbilisi, Kutaisi and Batumi on the same or the next day in validated active and passive boxes with calibrated temperature loggers.
Before signing
A depot that answers these questions with documents rather than descriptions is usually a safe choice. Sponsors preparing a qualification visit in Georgia can start by contacting GeoStorage to arrange an audit of the Tbilisi facility.
