Stability and Shelf-Life Data: Supporting Label Claims

1. Key takeaways

The labelling requirements of Prakas No. 1258 explicitly include two items: manufacturing date, batch number and expiry date and storage conditions. Both labelling entries must be backed by technical data; otherwise the review will demand supplementary documents or a narrowed claim.

The technical data behind these two claims is the stability / shelf-life study, and its conclusions must land in three places at once: Module C (other relevant specifications), Module D (design verification and validation) and Module E (labelling).

Landing the conclusions in three modules is less duplicative than it sounds. Module C states the specifications — the shelf life and storage conditions as claims; Module D records the study that substantiates them; Module E carries them into the label text. The three placements must quote the same conclusions, not paraphrase them differently, because any numerical or qualitative divergence among the three invites a deficiency question about which version is the real claim. A single controlled source for the stability conclusions, feeding all three placements, is the practical answer.

GRZAN note: 2 of the mandatory labelling items are supported by stability data (expiry date, storage conditions); the conclusions must land in 3 CSDT modules (C, D, E); Cambodia has a tropical monsoon climate, so the storage-conditions claim needs to cover high temperature and high humidity scenarios (practical interpretation).

2. Legal basis

3. Expert insights

1. Cambodia has no published list of stability testing conditions, but the climate itself is an implicit requirement. Cambodia has a tropical monsoon climate: high temperatures all year round and high humidity in the rainy season. No official temperature and humidity conditions for stability testing are prescribed, but if the storage conditions declared on the label are plainly unsuited to the local climate (for example, requiring a controlled environment that is generally unavailable locally), quality risks and regulatory liability arise in actual distribution. Include high temperature and high humidity scenarios in the stability study (practical interpretation).

1. The expiry-date claim and batch-number management are the foundation of post-market traceability. AMDD Article 12 requires the recording of device malfunctions and performance deterioration, and those records must be able to point to specific batches. The batch-number rule on the label must therefore be fixed at the registration stage and kept consistent with the company’s production batch system and the distributor’s import/export record system — three systems, one rule.

1. ‘Other relevant specifications’ is the natural landing point for stability data. The ‘other relevant specifications’ item in Module C is often ignored or filled in vaguely. Shelf life, storage conditions, transport conditions and limits on the use environment belong exactly under this item.

1. The absence of prescribed test conditions makes the study protocol itself part of the review. Because reviewers cannot check the study against a published Cambodian condition set, the conditions chosen, their rationale and the acceptance criteria defined before the study began are what the review examines. A protocol that states why the selected conditions bracket the local distribution environment reads as deliberate; a protocol that lists conditions without a rationale reads as inherited from another market. Writing the rationale into the protocol costs little and answers the question before it is asked.

1. The relationship between the expiry-date claim and the storage-conditions claim is conditional, not parallel. A shelf life is only as long as the conditions attached to it; the same product can carry different expiry dates under different declared storage conditions. This coupling is why the label entries must be finalised together: shortening the declared conditions without re-examining the expiry claim, or extending the claim without confirming the conditions, leaves one entry unsupported by the data behind the other. Reviewers read the two entries as a single statement, and the dossier should present them that way.

4. Practical recommendations

1. Finalise the stability data conclusions before the label is finalised. The order runs from the stability study, through the expiry-date and storage-condition conclusions, to label finalisation. Doing it in reverse leaves the label printed without data behind it, and once a label bearing an unsupported claim circulates in the distribution chain, correcting it becomes a field action rather than a document edit.
2. Fix the batch-number rule once and write it into the quality-system documents. Batch numbers should trace to the production batch, the sterilisation batch (where applicable) and the batches of key raw materials, so post-market problems can be located quickly.
3. Prepare additional transport/storage instructions for local distribution conditions. For temperature-sensitive products, give handling advice for the conditions commonly found in Cambodia in the instructions for use, reducing quality risk in the distribution chain (practical interpretation); for temperature-sensitive products these instructions are not advisory courtesy — they are the operational complement to the declared storage conditions, and reviewers may check that the two are consistent.

5. Verification checklist

• □ Stability study completed with an expiry-date conclusion
• □ Expiry date and storage conditions on the label backed by data
• □ Conclusions reflected in all three CSDT modules (C, D and E)
• □ High temperature and high humidity scenarios considered in the stability study (practical interpretation)
• □ Batch-number rule fixed and written into the quality-system documents
• □ Temperature-sensitive products have transport/storage instructions for local conditions

Regulatory information verified as of 29 October 2026.

In Southeast Asia, GRZAN’s core capabilities focus on three areas. First, tracking the legislative progress of dedicated medical-device laws across member states — Singapore, Malaysia, Thailand, Indonesia, the Philippines and Vietnam have each established written device regulatory frameworks, whereas Cambodia still has no dedicated Medical Device Act; the current rules are pieced together from three layers: the registration-number legal basis provided by the Law on Drug Management 1996 and its 2007 amendment, the classification and procedures provided by Prakas No. 1258 (2012), and the technical framework provided by the ASEAN Medical Device Directive, so compliance certainty is markedly lower than in markets that have completed legislation. Second, local authorised representative services: GRZAN can act as the manufacturer’s statutory representative in Cambodia, handling registration submissions, regulatory communication and post-market reporting obligations, and assisting with the practical arrangements for a Cambodian registered pharmacist and the licence for pharmaceutical import and export enterprises. Third, quality-system and testing support: GRZAN assists in establishing a quality management system conforming to ISO 13485 and in organising the technical dossier under the ASEAN Common Submission Dossier Template (CSDT).

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