SFDA item 39 · II. Quality changes · II.2 Finished product e) Container closure system
Change in 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 39 — official PDF, p. 49 ↗
| Variant | Change | Type |
|---|---|---|
| a.1 | Change in qualitative and quantitative composition — Solid pharmaceutical forms. | Type IA(IN) |
| a.2 | Change in qualitative and quantitative composition — Semi-solid and non-sterile liquid pharmaceutical forms. | Type IB |
| a.3 | Change in qualitative and quantitative composition — Sterile medicinal products and biological/ immunological medicinal products. | Type II |
| a.4 | Change in qualitative and quantitative composition — The change relates to a less protective pack where there are associated changes in storage conditions and/or reduction in shelf life. | Type II |
| b.1 | Change in the container type or addition of a new container(*) — Solid, semi-solid and non-sterile liquid pharmaceutical forms. | Type IB |
| b.2 | Change in the container type or addition of a new container(*) — Sterile medicinal products and biological/ immunological medicinal products. | Type II |
| b.3 | Change in the container type or addition of a new container(*) — Deletion of an immediate packaging that does not lead to the complete deletion of a strength or pharmaceutical form | Type IA |
Conditions to be fulfilled and documentation to be supplied: see the official guideline, item 39.
EU European Union
Commission Guidelines C/2025/5045 — EUR-Lex ↗
Q.II.e.1 · Change in immediate packaging of the finished product
| Variant | Change | Type |
|---|---|---|
| a.1 | Change in qualitative and quantitative composition of an approved container — Solid pharmaceutical forms | Type IA |
| a.2 | Change in qualitative and quantitative composition of an approved container — Semi-solid and non-sterile liquid pharmaceutical forms | Type IB |
| a.3 | Change in qualitative and quantitative composition of an approved container — Sterile liquid finished products | Type II |
| a.4 | Change in qualitative and quantitative composition of an approved container — The change relates to a less protective pack where there are associated changes in storage conditions and/or reduction in shelf life | Type II |
| b.1 | Change in type of container or addition of a new container — Solid, semi-solid and non-sterile liquid pharmaceutical forms | Type IB |
| b.2 | Change in type of container or addition of a new container — Sterile finished products | Type II |
| c | Deletion of a container | Type IA |
US FDA US Food and Drug Administration
21 CFR 314.70 and FDA guidance — 2004 Guidance §IX (B–D), Att. C · 2014 AR Guidance App. A 5 · 21 CFR 314.70(b)(2)(vi), (c)(2)(i), (d)(2)(ix)
| Change | Category | Reference |
|---|---|---|
| Deletion of one container closure system/presentation while others remain (How Supplied labeling update) | Annual report | 21 CFR 314.70(d)(2)(ix) |
| Solid oral (and listed nonsterile liquid/semisolid) changes with same-or-better protection using materials already in CDER-approved products of that type; CCS already approved for other strengths | Annual report | 2004 §IX.D.4–7 |
| Any other CCS change that does not affect quality (default), e.g., solid-oral contact material not yet used in a CDER-approved product of the same type | CBE-30 supplement | 2004 §IX.C.1.a; 21 CFR 314.70(c)(2)(i) |
| Liquid/semisolid: polymeric contact material never used in a CDER-approved product of the same dosage form and route; type/composition change that may alter the impurity profile | Prior approval supplement | 21 CFR 314.70(b)(2)(vi); 2004 §IX.B.1 |
| Sterile product: change that may affect sterility assurance (ampule to vial, to bag or prefilled syringe, single- to multi-dose, silicone treatment) | Prior approval supplement | 2004 §IX.B.4 |
| New container closure system with less protective properties than the approved one | Prior approval supplement | 2004 §IX.B.6 |
Note: Some sterile-product changes are AR: glass supplier change without glass type/coating/dimension change (2014 App. A 5.4) and crimp-cap changes with validated CCI (App. A 5.5); dose-controlling components are always PAS (§IX.B.3). A pack change that also shortens shelf life or alters storage is a multiple related change taking the most restrictive category (§XII).
Other items in II.2 Finished product e) Container closure system
- 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
- 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.