SFDA item 44 · II. Quality changes · II.2 Finished product e) Container closure system
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)
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 44 — official PDF, p. 54 ↗
| Variant | Change | Type |
|---|---|---|
| a | Change that affects the product information | Type IA(IN) |
| b | Change that does not affect the product information | Type IA |
Conditions to be fulfilled and documentation to be supplied: see the official guideline, item 44.
EU European Union
Commission Guidelines C/2025/5045 — EUR-Lex ↗
Q.II.e.3 · Change in any part of the (primary) packaging material not in contact with the finished product formulation (such as colour of flip-off caps, colour code rings on ampoules)
| Variant | Change | Type |
|---|---|---|
| a | Change that affects the product information | Type IA(IN) |
| b | Change that does not affect the product information | 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: A change of needle-shield material falls under Q.IV.2 (integral medical device part) rather than Q.II.e.3.
US FDA US Food and Drug Administration
21 CFR 314.70 and FDA guidance — 2004 Guidance §IX.C.1.a, §IX.D.8 · 2014 AR Guidance App. A 5.5–5.6 · 21 CFR 314.70(d)(2)(ix)
| Change | Category | Reference |
|---|---|---|
| Flip-off cap colour change consistent with an established colour-coding system | Annual report | 2004 §IX.D.8; 2014 App. A 5.5 |
| Crimp-cap (ferrule/overseal) change without colour change and with CCI shown; removing cap markings to comply with the compendium | Annual report | 2014 App. A 5.5–5.6 |
| Resulting update of the product description/How Supplied labeling | Annual report | 21 CFR 314.70(d)(2)(ix) |
| Other non-contact primary component change not listed (e.g., needle-shield plastic), no effect on quality | CBE-30 supplement | 2004 §IX.C.1.a |
Note: A cap colour that departs from an established colour-coding system falls outside the AR example, and any change that could affect container-closure integrity or sterility assurance of a sterile product is PAS (§IX.B.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
- 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.