SFDA item 47 · II. Quality changes · II.2 Finished product f) Stability
Change in the shelf-life or storage conditions of the finished product
Variation category under SFDA, EU and US FDA rules for this change, with the variant wording as published.
SFDA Saudi Food and Drug Authority
Guidelines for Variation Requirements v6.3 (DS-G-006), item 47 — official PDF, p. 56 ↗
| Variant | Change | Type |
|---|---|---|
| a.1 | Reduction of the shelf-life of the finished product — As packaged for sale | Type IA(IN) |
| a.2 | Reduction of the shelf-life of the finished product — After first opening | Type IA(IN) |
| a.3 | Reduction of the shelf-life of the finished product — After dilution or reconstitution | Type IA(IN) |
| b.1 | Extension of the shelf-life of the finished product — As packaged for sale (supported by real time data) | Type IB |
| b.2 | Extension of the shelf-life of the finished product — After first opening (supported by real time data) | Type IB |
| b.3 | Extension of the shelf-life of the finished product — After dilution or reconstitution (supported by real time data) | Type IB |
| b.4 | Extension of the shelf-life of the finished product — Extension of the shelf-life of a biological/immunological medicinal product in accordance with an approved stability protocol | Type IB |
| c | Change in storage conditions of the finished product or the diluted/reconstituted product | Type IB |
| d | Change in storage conditions for biological medicinal products, when the stability studies have not been performed in accordance with an approved stability protocol | Type II |
| e | Change to an approved stability protocol | Type IA |
Conditions to be fulfilled and documentation to be supplied: see the official guideline, item 47.
EU European Union
Commission Guidelines C/2025/5045 — EUR-Lex ↗
Q.II.f.1 · Change in the shelf life or storage conditions of the finished product
| Variant | Change | Type |
|---|---|---|
| a.1 | Reduction of the shelf life of the finished product — As packaged for sale | Type IA(IN) |
| a.2 | Reduction of the shelf life of the finished product — After first opening | Type IA(IN) |
| a.3 | Reduction of the shelf life of the finished product — After dilution or reconstitution | Type IA(IN) |
| b.1 | Extension of the shelf life of the finished product — As packaged for sale (supported by real time data, fully in line with the stability protocol) | Type IA(IN) |
| b.2 | Extension of the shelf life of the finished product — After first opening (supported by real time data) | Type IB |
| b.3 | Extension of the shelf life of the finished product — After dilution or reconstitution (supported by real time data) | Type IB |
| b.4 | Extension of the shelf life of the finished product — Extension of the shelf life of the finished product based on extrapolation or stability modelling not in accordance with relevant stability guidelines | Type II |
| b.5 | Extension of the shelf life of the finished product — Extension of the shelf life of the finished product based on extrapolation of stability data in accordance with relevant stability guidelines | Type IB |
| c | Change in storage conditions of a biological finished product | Type II |
| d | Change in storage conditions of the finished product or the diluted/reconstituted product | Type IB |
| e | Change to an approved stability protocol of the finished product | Type IA |
US FDA US Food and Drug Administration
21 CFR 314.70 and FDA guidance — 21 CFR 314.70(c), (d)(2)(vi), (e) · 2004 Guidance §XI.A–C, §X.B.7 · 2014 AR Guidance App. A 7.1–7.2
| Change | Category | Reference |
|---|---|---|
| Extension (as packaged, in-use or reconstituted) on full real-time data from pilot-scale or larger batches under the approved stability protocol | Annual report | 2014 App. A 7.1; 21 CFR 314.70(d)(2)(vi); 2004 §XI.C.1 |
| Protocol edits listed as AR: add time points, delete time points beyond expiry, move to ICH storage conditions; IR solid oral may drop identity/hardness if dissolution is tested | Annual report | 2004 §XI.C.2–3; 2014 App. A 7.2 |
| Reduction of the expiration dating period (as packaged, after opening, or after reconstitution) | CBE-30 supplement | 2004 §XI.B.1 |
| Re-extension of an expiry that was previously reduced, even with data under the approved protocol | CBE-30 supplement | 2004 §XI.B.1 |
| Extension on data from a new or unapproved protocol; adding a stability protocol or changing an approved one beyond the listed AR edits | Prior approval supplement | 2004 §XI.A.2–4; 21 CFR 314.70(e) |
| Change in labeled storage conditions (incl. for the diluted/reconstituted product) | Prior approval supplement | 2004 §X.B.7 |
Note: FDA guidance does not treat in-use or post-reconstitution periods separately from expiration dating. 2014 App. A 7.1 extends the AR route to pilot-scale batches (2004 §XI.A.4 had required PAS). Neither 314.70 nor the 2004 or 2014 guidance exempts storage-condition changes from §X.B.7, so even a more restrictive labeled storage condition is PAS.
Other items in II.2 Finished product f) Stability
Not regulatory advice. The binding text is each regulator's current official document; confirm the category with the authority before filing. FDA publishes no classification table: the US category follows FDA guidance or, where the guidance does not name the change, the closest example under 21 CFR 314.70.