This is an archived version. Please see the current version here: Q. QUALITY CHANGES – Q.I ACTIVE SUBSTANCE – Q.I.d) Stability
#bid1
| B.I.d.1 Change in the re-test period/storage period or storage conditions of the active substance where no Ph. Eur. Certificate of Suitability covering the retest period is part of the approved dossier | Conditions to be fulfilled | Documentation to be supplied | Procedure type |
| a) Re-test period/storage period | |||
| 1. Reduction | 1 | 1, 2, 3 | IA |
| 2. Extension of the retest period based on extrapolation of stability data not in accordance with ICH/VICH guidelines* | II | ||
| 3. Extension of storage period of a biological/ immunological active substance not in accordance with an approved stability protocol | II | ||
| 4. Extension or introduction of a re-test period/storage period supported by real time data | 1, 2, 3 | IB | |
| b) Storage conditions | |||
| 1. Change to more restrictive storage conditions of the active substance | 1 | 1, 2, 3 | IA |
| 2. Change in storage conditions of biological/ immunological active substances, when the stability studies have not been performed in accordance with a currently approved stability protocol | II | ||
| 3. Change in storage conditions of the active substance | 1, 2, 3 | IB | |
| c) Change to an approved stability protocol | 1, 2 | 1, 4 | IA |
| Conditions | |||
| 1. The change should not be the result of unexpected events arising during manufacture or because of stability concerns. | |||
| 2. The changes do not concern a widening of the acceptance criteria in the parameters tested, a removal of stability indicating parameters or a reduction in the frequency of testing. | |||
| Documentation | |||
| 1. Amendment of the relevant section(s) of the dossier (presented in the EU-CTD format or NTA volume 6B format for veterinary products, as appropriate). This must contain results of appropriate real time stability studies, conducted in accordance with the relevant stability guidelines on at least two (three for biological medicinal products) pilot or production scale batches of the active substance in the authorised packaging material and covering the duration of the requested re-test period or requested storage conditions. | |||
| 2. Confirmation that stability studies have been done to the currently approved protocol. The studies must show that the agreed relevant specifications are still met. | |||
| 3. Copy of approved specifications of the active substance. | |||
| 4. Justification for the proposed changes. | |||
| * Note: retest period not applicable for biological/immunological active substance | |||