On-going stability monitoring programme
Article 48
1. Manufacturers shall put in place a documented, on-going stability programme to monitor the stability data of active substances. The results shall be used to confirm appropriate storage conditions and retest or expiry dates. 2. The test procedures used in stability studies shall be appropriate for the active substance and validated. 3. Stability samples shall be stored in containers that simulate the market container. 4. The first three production scale batches shall be placed on the on-going stability programme to confirm the retest or expiry date. 5. By way of derogation from paragraph 4, where data from previous studies show that the active substance is expected to remain stable for at least two years, fewer than three batches may be used. 6. After the first three production scale batches being placed on the on-going stability programme, at least one batch per year of the active substance manufactured shall be included into the on-going stability programme, unless none are produced in a given year or a different frequency is otherwise justified. 7. In case of active substances with short shelf life, stability testing shall be done more frequently. When data exist confirming that the stability of the active substance is not compromised, elimination of specific test intervals may be considered. 8. Where appropriate, the stability testing of active substances shall be performed in accordance with the conditions set out in the Guideline on stability: stability testing of new veterinary drug substances and medicinal products ( 5 ) .