SFDA item 34 · II. Quality changes · II.2 Finished product c) Control of excipients
Change in supplier of an excipient or reagent without TSE risk
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 34 — official PDF, p. 45 ↗
| Variant | Change | Type |
|---|---|---|
| - | Change in supplier of an excipient or reagent without TSE risk | Type IA |
Conditions to be fulfilled and documentation to be supplied: see the official guideline, item 34.
EU European Union
Commission Guidelines C/2025/5045 — EUR-Lex ↗
Q.II.c.3 · Change in source of an excipient or reagent with TSE risk, which is used in the manufacture of an active substance or in a finished product
| Variant | Change | Type |
|---|---|---|
| a | Change in the source of an excipient or reagent from a TSE risk material to a material of vegetable or synthetic origin | Type IA |
| b | Change in the source of an excipient or reagent which is unlikely to present any risk of TSE contamination | Type IA |
| c | Change in the source of a TSE risk material, or introduction of a TSE risk material, not covered by a European Pharmacopoeial TSE certificate of suitability | Type II |
Q.II.c.4 · Change in synthesis, manufacturing or recovery of an excipient (when described in the dossier)
| Variant | Change | Type |
|---|---|---|
| a | Minor change in synthesis, manufacturing or recovery of an excipient | Type IA |
| b | Change in the manufacturing site, synthesis, manufacturing or recovery of the excipient which may affect the quality, safety or efficacy of the finished product | Type II |
| c | Deletion of one manufacturing process of an excipient | Type IA |
| d | Addition or replacement of a site responsible for the manufacture or testing of an excipient, when required to be described in the dossier | Type IB |
Note: There is no exact EU item. Q.II.c.3(b) covers a change in source of an excipient or reagent unlikely to present a TSE risk; a new excipient manufacturing site described in the dossier is Q.II.c.4(d).
US FDA US Food and Drug Administration
21 CFR 314.70 and FDA guidance — 2014 AR Guidance App. A 1.3, App. B 1.4 · 21 CFR 314.70(a)(1)(i), (d)
| Change | Category | Reference |
|---|---|---|
| Supplier not named in the approved application; grade and specification unchanged (supplier qualification handled under CGMP) | Not reportable | 21 CFR 314.70(a)(1)(i) |
| Supplier (or DMF holder) named in the application replaced or added; excipient specification and technical grade unchanged | Annual report | 2014 App. A 1.3; App. B 1.4 |
Note: If the new supplier's material has a different grade or specification, classify by the specification or composition change instead (e.g., relaxation PAS, §VIII.B.1; release-controlling excipients of modified-release products per SUPAC-MR). A supplier not named in the approved application is not a condition of approval, so changing it needs no 314.70 notice (314.70(a)(1)).
Other items in II.2 Finished product c) Control of excipients
- 31 · Change in the specification parameters and/or limits of an excipient
- 32 · Change in test procedure for an excipient
- 33 · Change in source of an excipient or reagent with TSE risk
- 35 · Change in synthesis or recovery of a non-pharmacopeial excipient (when described in the dossier) or a novel excipient
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.