Meeting GSP is not a matter of buying the right equipment and being done. Most of the time and most of the risk sit in the records: proving that the room holds the required conditions, at every position, at every moment. This article follows the actual sequence a business goes through.
Getting the nature of it right before you start
A food store only has to hold the temperature. A GSP store has to prove it, with data and records. That difference governs the whole approach to design, construction and operation.
The reason is very practical: a medicine stored outside its conditions can lose potency without anything being visible. The batch is intact, the packaging still looks fine. So the principle running through everything is there must be no gap in the data — not even during a power cut or maintenance.
Stage 1 — Defining requirements and design
- List the product groups to be stored and the corresponding temperature range from each manufacturer’s instructions
- Establish throughput and goods flow — inbound, outbound, quarantine, returns
- Design with redundancy for both the refrigeration system and the power supply
- Provide a separate quarantine area for goods awaiting testing, returned goods and goods suspected of not meeting specification
- Choose a monitoring system with continuous recording and out-of-limit alarms that work outside working hours too
This is the stage that decides the most. Leaving out the quarantine area or omitting redundancy at the design stage means expensive rework once the audit team asks for them.
Stage 2 — Construction and installation
- Erect the envelope, fit the specialist doors, install the refrigeration system and pipework
- Install the temperature monitoring system, wire up the alarms and the standby power supply
- Collect the fabrication and inspection records for the pressure equipment in a
- Keep the material documents: panel, equipment and sensor certificates
The point most often missed: collect the records during construction, rather than going back to the supplier for them when the audit is already being prepared. This is why it is worth choosing a contractor that fabricates its own equipment — the records come with it from the start.
Stage 3 — Temperature mapping
This is the item a GSP audit team always asks to see, and also the one businesses most often leave out.
Temperature inside a cold room is not uniform. The area near the door, the sheltered corners and any spot where goods block the airflow are always warmer than the rest. If sensors are only put where it is convenient, the recorded data does not reflect where the goods actually sit.
Mapping measures how temperature is distributed through the whole room, identifies the hot and cold spots, and from there decides where the official monitoring sensors go and and which zones may be used for storage. The results have to be documented.
Stage 4 — Writing the procedures
The physical facility is only half of it. The other half is a written set of procedures:
- Procedure for operating the store and checking temperature daily
- Procedure for receipt, dispatch and quarantine of goods
- Procedure for handling a temperature deviation — who decides, and on what basis
- Procedure for power failure and equipment breakdown
- Procedure for routine cleaning and maintenance
- Staff training records and assignment of responsibilities
- Plan for periodic self-inspection
The power-failure procedure is the one to watch: it has to be written beforehand, not improvised on the day and written up afterwards. And the temperature data covering the outage has to exist — no gaps.
Stage 5 — Test run and handover
- Leak-test the envelope and check the doors operate correctly
- Run the system to check pull-down time and temperature stability
- Check the alarm system works, including testing an out-of-limit condition
- Test the changeover to standby power
- Compare the sensor readings against a calibrated reference instrument
- Hand over the complete technical records and operating instructions
Common sticking points during an audit
- No temperature map or one that exists but has not been updated after the storage layout changed
- Gaps in the temperature data during a power cut or maintenance
- No quarantine area or one that exists but is not clearly separated
- Pressure vessel inspection records expired or missing
- Sensors not calibrated or with no calibration records
- Procedures exist but the staff do not know them — audit teams usually question the operators directly
How far Tân Long supports you
Tân Long designs and builds the cold storage itself along with the monitoring system and the redundancy, supports the temperature mapping, and hands over the technical records. The quality management procedures and the staff training records are the business’s responsibility, usually with a consultant specialising in GSP.
Frequently asked questions about building a GSP-compliant store
How long does a GSP store take?
It depends on the size of the store and how ready the business’s procedures already are. Building the physical facility is usually not the longest step — writing the procedures and completing the records is what takes the time.
What is temperature mapping and why is it mandatory?
It is the result of measuring how temperature is distributed through the whole room in order to identify hot and cold spots. From there you decide where the monitoring sensors go and which zones may be used for storage. Without it, the monitoring data does not represent where the goods actually sit.
Why must the temperature data have no gaps?
Because a medicine stored outside its conditions can lose potency with nothing detectable by the senses. A gap in the data means you cannot prove the batch held its conditions during that period.
What is the quarantine area for?
To keep goods awaiting testing, returned goods, expired goods and goods suspected of not meeting specification separate, so those batches are not released to the market by mistake. A missing quarantine area is a common audit finding.
When should equipment records be collected?
During construction, rather than going back to the supplier for them once the audit is being prepared. Choosing a contractor that fabricates its own equipment means the fabrication and inspection records come with it from the start.
Which parts of the GSP process does Tân Long support?
Tân Long handles the cold storage side: design, construction, the monitoring system, the redundancy, support with temperature mapping, and handover of the technical records. The quality management procedures and staff training records are done by the business.
Related pages
- GSP-compliant pharmaceutical cold stores: design and construction
- What is a GSP store? The Good Storage Practice standard
- Cold storage for vaccines
- Refrigeration system inspection: which equipment is mandatory
- Data loggers: temperature monitoring and recording
- Cold storage contractor services
Doanh Nghiệp Đang Cần Khảo Sát, Nâng Cấp Hoặc Thiết Kế Mới Hệ Thống Lạnh Công Nghiệp?
Đội ngũ kỹ sư Cơ Điện Lạnh Tân Long với hơn 18 năm kinh nghiệm thực chiến chỉ đạo hơn 29 đại dự án quốc gia, cam kết tư vấn tính toán phụ tải nhiệt chuẩn xác, tối ưu hóa hệ số hiệu suất COP, chuyển dịch môi chất tự nhiên NH3/CO2 và tiết kiệm 20–30% chi phí điện năng vận hành.
Kỹ sư Nguyễn Toàn Thịnh (Giám đốc Kỹ thuật)
Hơn 18 năm kinh nghiệm thực chiến chỉ đạo tư vấn thiết kế và thi công hệ thống lạnh công nghiệp nặng, kho tự động ASRS và cấp đông IQF qua hơn 29 đại dự án quốc gia.
