SFDA item 42 · II. Quality changes · II.2 Finished product e) Container closure system
Change in shape or dimensions of the container or closure (immediate packaging)
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 42 — official PDF, p. 52 ↗
| Variant | Change | Type |
|---|---|---|
| a | Non-sterile medicinal products | Type IA |
| b | The change in shape or dimensions concerns a fundamental part of the packaging material, which may have a significant impact on the delivery, use, safety or stability of the finished product | Type II |
| c | Sterile medicinal products | Type IB |
Conditions to be fulfilled and documentation to be supplied: see the official guideline, item 42.
EU European Union
Commission Guidelines C/2025/5045 — EUR-Lex ↗
Q.II.e.2 · Change in shape or dimensions of the container or closure (immediate packaging) of the finished product
| Variant | Change | Type |
|---|---|---|
| a | Non-sterile finished products | Type IA |
| b | Sterile finished products | Type IB |
US FDA US Food and Drug Administration
21 CFR 314.70 and FDA guidance — 2004 Guidance §IX.B.3–4, §IX.C.2.a, §IX.D.2 · 21 CFR 314.70(b)(2)(vi), (c)(6)(ii), (d)(2)(iv)
| Change | Category | Reference |
|---|---|---|
| Nonsterile solid dosage form: container size/shape (same count, same container closure type) | Annual report | 2004 §IX.D.2; 21 CFR 314.70(d)(2)(iv) |
| Nonsterile liquid/semisolid: container size/shape without a change of container closure system or labeled amount | CBE-0 supplement | 2004 §IX.C.2.a; 21 CFR 314.70(c)(6)(ii) |
| Sterile drug product: any container size/shape change | Prior approval supplement | 2004 §IX.B.4 |
| Dimensional change to a dose-controlling component (e.g., MDI valve/actuator, nasal pump) | Prior approval supplement | 21 CFR 314.70(b)(2)(vi); 2004 §IX.B.3 |
Note: Any size or shape change of a sterile drug product container is PAS (§IX.B.4); CBE-30 applies only to sterile drug substance containers (§IX.C.1.b). Increasing container wall thickness in the listed nonsterile cases is AR (§IX.D.4–5, 7).
Other items in II.2 Finished product e) Container closure system
- 39 · Change in immediate packaging of the finished product
- 40 · Change in the specification parameters and/or limits of the immediate packaging of the finished product
- 41 · Change in test procedure for the immediate packaging of the finished product
- 43 · Change in pack size of the finished product
- 44 · Change in any part of the (primary) packaging material not in contact with the finished product formulation (such as color of flip-off caps, color code rings on ampoules, change of needle shield (different plastic used)
- 45 · Change in supplier of packaging components or devices (when mentioned in the dossier)
- 46 · Change in the packaging design of the primary and/or Secondary packaging not in contact with the finished product formulation
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.