SFDA item 45 · II. Quality changes · II.2 Finished product e) Container closure system
Change in supplier of packaging components or devices (when mentioned in the dossier)
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 45 — official PDF, p. 54 ↗
| Variant | Change | Type |
|---|---|---|
| a | Deletion of a supplier | Type IA |
| b | Replacement or addition of a supplier | Type IA |
| c | Any change to suppliers of spacer devices for metered dose inhalers | Type II |
Conditions to be fulfilled and documentation to be supplied: see the official guideline, item 45.
EU European Union
Commission Guidelines C/2025/5045 — EUR-Lex ↗
Q.II.e.7 · Change in manufacturer, sterilisation process or supplier of packaging components (when mentioned in the dossier)
| Variant | Change | Type |
|---|---|---|
| a | Addition or replacement of a manufacturer or supplier | Type IA |
| b | Addition or replacement of a site responsible for sterilisation of a packaging component, and/or a change to the sterilisation process | Type IB |
E.5 · Deletion of manufacturing sites for an active substance, intermediate or finished product, storage of master and/or working cell bank, primary and/or secondary packaging site, manufacturer responsible for batch release, site where quality control takes place, and/or supplier of a packaging component, medical device (part), starting material, reagent and/or excipient (when mentioned in the dossier)
| Variant | Change | Type |
|---|---|---|
| - | Deletion of manufacturing sites for an active substance, intermediate or finished product, storage of master and/or working cell bank, primary and/or secondary packaging site, manufacturer responsible for batch release, site where quality control takes place, and/or supplier of a packaging component, medical device (part), starting material, reagent and/or excipient (when mentioned in the dossier) | Type IA |
Q.IV.1 · Changes to a device co-packaged with the medicinal product or referenced in the product information
| Variant | Change | Type |
|---|---|---|
| a | Addition or replacement of a co-packaged device or referenced device | Type IA(IN) |
| b | Addition, replacement or other changes of a co-packaged or referenced device that may have a significant impact to the delivery, quality, safety and/or efficacy of the medicinal product | Type II |
| c | Deletion of a co-packaged or referenced device | Type IA(IN) |
| d | Minor change for a co-packaged device or referenced device that does not impact the delivery, quality, safety and/or efficacy of the medicinal product or the usability of the device | Type IA |
Q.IV.2 · Changes to an integral medical device (part)
| Variant | Change | Type |
|---|---|---|
| a | Addition or replacement of an integral device (part) or major change to the materials and/or design and/or performance characteristics of an integral device which may have a significant impact on the delivery or the quality, safety, or efficacy of the medicinal product | Type II |
| b | Addition or replacement of an integral device (part) which does not have a significant impact on the performance, delivery, quality, safety or efficacy of the medicinal product | Type IB |
| c | Deletion of an integral medical device (part) that does not lead to the complete deletion of a strength or pharmaceutical form | Type IA(IN) |
| d | Change of a material of a device (part) not in contact with the medicinal product | Type IA |
| e | Change of a material of a device (part) in contact with the medicinal product that does not have a significant impact on the performance, safety, quality or efficacy of the medicinal product and does not contain materials of human or animal origin for which assessment is required of viral safety data or TSE risk | Type IB |
| f | Addition or replacement of a supplier/manufacturer of an existing device (part) | Type IA |
| g | Addition or replacement of a site responsible for sterilisation of the device (part) and/or change to the sterilisation process of the device (part) when supplied as sterile | Type IB |
| h | Other minor change to an integral device (part) | Type IA |
Note: Q.II.e.7(a) covers suppliers of packaging components; deleting a supplier is E.5; suppliers of co-packaged devices such as spacers fall under Q.IV.1, and of integral devices under Q.IV.2(f).
US FDA US Food and Drug Administration
21 CFR 314.70 and FDA guidance — 2004 Guidance §VI.A fn 12, §IX.B.3, §IX.C.1.a · 2014 AR Guidance App. A 5.2, 5.4 · 21 CFR 314.70(b)(2)(vi)
| Change | Category | Reference |
|---|---|---|
| Component fabricator or packaging-material maker replaced, added or deleted with no change in dimensions, composition or processing aids | Not reportable | 2004 §VI.A fn 12 |
| Parenteral glass supplier change with same glass type, coating and dimensions; contract washing/siliconization of stoppers | Annual report | 2014 App. A 5.4; App. A 5.2 |
| New supplier's component also differs (composition, dimensions): classified by that change, CBE-30 being the §IX default | CBE-30 supplement | 2004 §VI.A fn 12; §IX.C.1.a |
| Dose-controlling component (e.g., MDI valve/actuator) or a co-packaged MDI spacer from a new supplier | Prior approval supplement | 2004 §IX.B.3; 21 CFR 314.70(b)(2)(vi) |
Note: In the US, spacers are usually separately cleared devices; PAS applies where the spacer is part of the approved, dose-controlling presentation (§IX.B.3). A change in contract sterilization site for packaging components with an unchanged process is AR (§VI.D.4).
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
- 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)
- 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.