SFDA item 40 · II. Quality changes · II.2 Finished product e) Container closure system
Change in the specification parameters and/or limits of 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 40 — official PDF, p. 50 ↗
| Variant | Change | Type |
|---|---|---|
| a | Tightening of specification limits. | Type IA |
| b | Addition of a new specification parameter to the specification. | Type IA |
| c | Addition or replacement of a specification parameter as a result of a safety or quality issue. | Type IB |
| d | Deletion of a non-significant specification parameter (e. g deletion of an obsolete test). | Type IA |
Conditions to be fulfilled and documentation to be supplied: see the official guideline, item 40.
EU European Union
Commission Guidelines C/2025/5045 — EUR-Lex ↗
Q.II.e.4 · Change in the specification attribute and/or acceptance criteria of the immediate packaging of the finished product
| Variant | Change | Type |
|---|---|---|
| a | Change of specification acceptance criteria | Type IA |
| b | Addition of a specification attribute to the specification with its corresponding analytical procedure | Type IA |
| c | Deletion of a non-significant or obsolete specification attribute | Type IA |
| d | Replacement of a specification attribute with its corresponding analytical procedure | Type IB |
US FDA US Food and Drug Administration
21 CFR 314.70 and FDA guidance — 2004 Guidance §VIII.B.1–2, §VIII.D.3, §IX.A · 2014 AR Guidance App. A 4.8
| Change | Category | Reference |
|---|---|---|
| Tightening of a packaging-component acceptance criterion | Annual report | 2004 §VIII.D.3 |
| Addition of a packaging-material test for increased assurance | Annual report | 2014 App. A 4.8 |
| Relaxing a criterion or deleting a test (including obsolete tests) | Prior approval supplement | 2004 §VIII.B.1–2 |
Note: Specification revisions that accompany a packaging change are not a separate change: only the packaging change's category applies (§IX.A). Deleting even an obsolete packaging test is PAS (§VIII.B.2).
Other items in II.2 Finished product e) Container closure system
- 39 · Change in immediate packaging of the finished product
- 41 · Change in test procedure for 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.