SFDA item 23 · II. Quality changes · II.2 Finished product a) Description and composition
Change in coating weight of oral dosage forms or change in weight of capsule shells
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 23 — official PDF, p. 32 ↗
| Variant | Change | Type |
|---|---|---|
| a | Solid oral pharmaceutical forms. | Type IA(IN) |
| b | Gastro-resistant, modified or prolonged release pharmaceutical forms where the coating is a critical factor for the release mechanism. | Type II |
Conditions to be fulfilled and documentation to be supplied: see the official guideline, item 23.
EU European Union
Commission Guidelines C/2025/5045 — EUR-Lex ↗
Q.II.a.4 · Change in coating weight of oral dosage forms or change in weight of capsule shells
| Variant | Change | Type |
|---|---|---|
| a | Solid oral pharmaceutical forms | Type IA |
| b | Gastro-resistant pharmaceutical forms where the coating or capsule shell is a critical factor for the release mechanism | Type IB |
| c | Modified or prolonged release pharmaceutical forms where the coating or capsule shell is a critical factor for the release mechanism | Type II |
US FDA US Food and Drug Administration
21 CFR 314.70 and FDA guidance — 2014 AR Guidance App. A 1.2, App. B 1.3 · 2004 Guidance §V, §VII.B.1 · 21 CFR 314.70(b)(2)(i)
| Change | Category | Reference |
|---|---|---|
| Immediate-release film-coat weight change within ±1% w/w of total formulation (SUPAC level 1) | Annual report | 2014 App. B 1.3 |
| Immediate-release coating change where coating material and quantity are approved for a similar product, with release, specs and stability unchanged | Annual report | 2014 App. A 1.2 |
| Larger coating or capsule-shell weight change, or any change to a release-controlling coating | Prior approval supplement | 2004 §V, §VII.B.1; 21 CFR 314.70(b)(2)(i) |
Note: The AR boundary is SUPAC level 1 (2014 App. B 1.3). For modified-release forms, the ≤5% release-controlling AR route (App. B 1.5) requires unchanged total weight, so a pure coating-weight change does not qualify. Capsule-shell weight changes are treated as quantitative formulation changes (PAS, §V); a same-grade, same-specification shell supplier change is AR (App. B 1.4).
Other items in II.2 Finished product a) Description and composition
- 20 · Change or addition of imprints, bossing or other markings including replacement, or addition of inks used for product marking.
- 21 · Change in the shape or dimensions of the pharmaceutical form*
- 22 · Changes in the composition (excipients) of the finished product
- 24 · Change in concentration of a single-dose, total use parenteral product, where the amount of active substance per unit dose (i.e. the strength) remains the same
- 25 · Deletion of the solvent/diluent container from the pack
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.