#qid1
| Q.I.d.1 Change in the re-test period/storage period or storage conditions of the active substance or intermediates used in the manufacturing process of the biological active substance | Condition to be fulfilled | Documentation to be supplied | Procedure type |
| (a) Re-test period/storage period | |||
| 1. Reduction of re-test period/storage period | 1 | 1, 2, 3, 4 | IA |
| 2. Introduction of re-test period/storage period | 1, 2, 3 | IB | |
| 3. Extension of the re-test period/storage period based on extrapolation or stability modelling not in accordance with relevant stability guidelines | II | ||
| 4. Extension of re-test period/storage period supported by real time data not in accordance with an approved stability protocol or an extension based on extrapolation of stability data in accordance with relevant stability guidelines | 1, 3 | IB | |
| 5. Extension of a re-test period/storage period supported by real time data fully in line with the stability protocol | 2 | 1, 2, 3 | IA |
| (b) Storage conditions | |||
| 1. Change to more restrictive storage conditions | 1, 3 | 1, 2, 3 | IA |
| 2. Change in storage conditions | 1, 2, 3 | IB | |
| (c) Change to an approved stability protocol | 1, 4 | 1, 4 | IA |
| Conditions | |||
| 1. The change should not be the result of unexpected events arising during manufacture or because of stability concerns. | |||
| 2. Stability studies have been performed in accordance with a currently approved stability protocol. Real time data are submitted. All batches meet their pre-defined specification at all time points. No unexpected trends have been observed. | |||
| 3. The physical state of the active substance has not changed. | |||
| 4. 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). This must contain results of appropriate real time stability studies, conducted in accordance with the relevant stability guidelines on three pilot or production scale batches of the active substance or intermediate in the authorised packaging material. | |||
| 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 (as annex to the application form). | |||
| 4. Justification for the proposed changes. | |||
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