GSP — Good Storage Practice — is the set of principles that keeps medicines and pharmaceutical materials at their declared quality from goods-in to dispatch. For starting materials it is the weakest-watched link in the supply chain, even though it decides whether the active still assays correctly when it reaches the plant.
The regulation in force
GSP in Vietnam is governed by Circular 36/2018/TT-BYT of 22 November 2018, issued by the Minister of Health and effective from 10 January 2019, as amended and supplemented by Circular 29/2020/TT-BYT and Circular 11/2025/TT-BYT.
Who must comply
The requirement applies to any establishment that stores medicines or pharmaceutical materials: manufacturers, importers and exporters, wholesalers and contract storage providers. For an ingredient distributor, GSP normally sits alongside GDP — Good Distribution Practice — since one covers conditions in the warehouse and the other covers conditions in transit, plus traceability.
What it requires in practice
- Personnel
- The person responsible for the warehouse must hold pharmaceutical qualifications and receive periodic refresher training on storage requirements.
- Functional zoning
- Goods-in, sampling, quarantine, storage and outbound staging must be separated into signed zones so that released and unreleased batches cannot mix.
- Environmental conditions
- Temperature and humidity must be controlled and recorded against each product's declared storage condition, with monitoring instruments and retained records.
- Stock rotation
- FIFO and FEFO — first in first out, first expired first out — so that stock does not age in place.
- Records
- Every batch must be traceable back to its manufacturer, its receiving date and the conditions under which it was held.
How to verify a supplier
- Ask for the GSP certificate itself, not just the claim. The certificate carries a number, the establishment name and the warehouse address.
- Check the warehouse address on the certificate against the address where goods are actually held. A mismatch is worth asking about.
- Check the scope: a certificate covering finished medicines does not automatically cover starting materials.
- Ask about GDP too if the goods will be transported. A compliant warehouse feeding an uncontrolled vehicle still breaks the chain in the middle.