A GSP-compliant pharmaceutical cold store is a facility for storing medicines, vaccines and biological products under Good Storage Practice principles, as set out in Circular 36/2018/TT-BYT. The storage temperature for vaccines and biologicals is usually 2°C to 8°C, while some specialist medicines require -20°C. Tan Long designs and builds GSP cold stores complete with a monitoring system, backup power and the technical documentation needed for the assessment.
How a GSP store differs from a food cold store
The biggest difference is not the temperature but the level of proof required. A food store only has to hold the temperature; a GSP store has to prove that every position in the store, at every moment, stayed within the permitted range — and keep that evidence.
The reason is that a medicine held outside its storage conditions can lose potency with nothing visible to the eye. The consignment looks intact, the packaging is perfect, but the active ingredient has degraded. The whole system is therefore designed around one principle: there must be no gap in the data.
The mandatory items of a GSP store
- A refrigeration system with standby capacity. The failure of one machine set must not interrupt storage.
- Continuous temperature monitoring and recording, with alerts when a threshold is exceeded, including outside working hours. Tan Long integrates PLC control cabinet with 24/7 alarm capability.
- Backup power, ensuring the system does not stop during a mains failure.
- A validated temperature mapping study, identifying the hot and cold spots so sensors are placed in the right locations.
- A separate quarantine area for goods awaiting inspection, returned goods or goods suspected of not meeting specification.
- A set of procedural documents for operation, deviation handling and periodic self-inspection.
Why temperature mapping is required
The temperature inside a cold chamber is not uniform. Areas near the door, hidden corners and places where goods block the air flow are always warmer than the rest. If a single sensor is placed wherever is convenient, the recorded data will not reflect where the goods actually sit.
Temperature mapping identifies the extreme points in the store, which then determines where the monitoring sensors go and which zones may be used for storage. This is an item the GSP assessment team always asks to see.
Handling a power failure — the question assessors always ask
A GSP store needs a clear procedure for a power failure: keep the store door closed, start the backup supply, follow and record how the temperature develops, then compare against the permitted threshold to decide the fate of the consignment afterwards.
The important point is that this procedure must be written beforehand, not improvised. And the temperature data for the period of the power failure must exist, with no interruption.
The delivery process at Tan Long
- Survey and requirements definition. The product groups to be stored, the required temperature range, the volume, the floor space and the power supply.
- Design of a system with standby capacity. The machine set configuration, the backup power solution, the layout of the quarantine area and the goods movement routes.
- Equipment manufacturing at the plant. The pressure equipment and ancillary equipment are manufactured by Tan Long, with manufacturing and inspection records included.
- Installation and monitoring integration. The enclosure, cold storage door, the refrigeration system, the PLC cabinet and temperature recording equipment.
- Temperature mapping and validation. Measuring the temperature distribution in the chamber and fixing the official sensor positions.
- Documentation handover. Technical documentation, inspection records, operating instructions and the deviation handling procedure.
Reference configuration table by product group
| Product group | Temperature range | Specific requirements | Unit price |
| Vaccines and biologicals | 2°C – 8°C | Standby capacity, 24/7 alarms, temperature mapping | Contact us for a quote. |
| Deep-frozen specialist medicines | -20°C | Deep sub-zero refrigeration, continuous monitoring | Contact us for a quote. |
| Multi-temperature pharmaceutical distribution store | Several chambers | Separate chambers, a dedicated quarantine area | Contact us for a quote. |
The actual configuration and the quotation are settled after a survey and once the assessment requirements of the company are clarified.
Tan Long scope of supply
- Cold stores for medicines, vaccines and biologicals, temperature range from 5°C to -40°C
- A refrigeration system with standby capacity and a backup power solution
- PLC and SCADA control cabinets with 24/7 temperature alarms and remote monitoring
- Pressure equipment manufacturing with inspection records as required by regulation
- Support with temperature mapping and the technical documentation for the GSP assessment
- Dedicated cold storage doors and a matched set of cold storage materials
Why choose Tan Long
We understand that a GSP store is a documentation problem, not only a refrigeration problem. The system is designed to prove the storage conditions, not merely to achieve them.
Equipment manufactured in-house at our plant, so the manufacturing and inspection records come with it from the start instead of having to be requested from a third-party supplier.
More than 20 years in industrial refrigeration, with full command of NH3, CO2 and Freon systems.
Frequently asked questions about GSP cold stores
What is a GSP cold store?
It is a store for medicines, vaccines and biologicals meeting Good Storage Practice principles under Circular 36/2018/TT-BYT, with strict requirements for temperature, humidity, the monitoring system and the set of procedural documents.
What temperature are vaccines stored at?
Vaccines and biologicals are usually stored at 2°C to 8°C. Some specialist medicines require deep freezing at -20°C. The specific range follows the manufacturer instructions for each product.
Why must a GSP store have backup power?
Because a medicine held outside its storage conditions can lose potency with nothing detectable by the senses. Backup power keeps the refrigeration system running during a mains failure, avoiding a gap in the documented data.
What is temperature mapping for?
The temperature in a store is not uniform at every position. Temperature mapping identifies the hot and cold spots so monitoring sensors can be placed correctly and so the zones permitted for storage can be defined. The GSP assessment team always asks to see it.
What is the quarantine area in a GSP store for?
To segregate goods awaiting inspection, returned goods, expired goods or goods suspected of not meeting specification, so that those batches are not released to the market by mistake.
What does Tan Long provide for a company building a GSP store?
Tan Long designs and builds the cold store itself together with the temperature monitoring system and the standby system, supports temperature mapping and hands over the technical documentation so the company can complete the facility conditions for its GSP assessment.
Related technical reading
- What is a GSP store? The Good Storage Practice standard
- ETC cold stores: storage requirements for medicines and vaccines
- Data loggers: monitoring and recording temperature in the cold chain
- The cold chain and where it tends to break
- Refrigeration system inspection: which equipment is mandatory
