SFDA item 41 · II. Quality changes · II.2 Finished product e) Container closure system
Change in test procedure for the immediate packaging 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 41 — official PDF, p. 51 ↗
| Variant | Change | Type |
|---|---|---|
| a | Minor changes to an approved test procedure | Type IA |
| b | Other changes to a test procedure (including replacement or addition) | Type IA |
| c | Deletion of a test procedure if an alternative test procedure is already authorized | Type IA |
Conditions to be fulfilled and documentation to be supplied: see the official guideline, item 41.
EU European Union
Commission Guidelines C/2025/5045 — EUR-Lex ↗
Q.II.e.5 · Change in analytical procedure for the immediate packaging of the finished product
| Variant | Change | Type |
|---|---|---|
| a | Minor change to an approved analytical procedure | Type IA |
| b | Other changes to an analytical procedure (including replacement or addition) | Type IA |
| c | Deletion of an analytical procedure if an alternative analytical procedure is already authorised | Type IA |
US FDA US Food and Drug Administration
21 CFR 314.70 and FDA guidance — 2004 Guidance §VIII.B.5, §VIII.C.2.b · 2014 AR Guidance App. A 4.3 · 21 CFR 314.70(d)(2)(vii)
| Change | Category | Reference |
|---|---|---|
| Minor edit keeping the original methodology, equivalent or better assurance, criteria unchanged | Annual report | 2014 App. A 4.3 |
| Add, revise or delete an alternative procedure giving the same or increased assurance | Annual report | 21 CFR 314.70(d)(2)(vii) |
| Other change or replacement of a packaging-component test procedure giving the same or increased assurance | CBE-0 supplement | 2004 §VIII.C.2.b |
| Change giving reduced assurance than the approved procedure | Prior approval supplement | 2004 §VIII.B.5 |
Note: Packaging-component methods are named explicitly in §VIII.C.2.b (same or increased assurance, CBE-0) and §VIII.B.5 (reduced assurance, PAS).
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
- 42 · Change in shape or dimensions of the container or closure (immediate packaging)
- 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.