SFDA item 31 · II. Quality changes · II.2 Finished product c) Control of excipients
Change in the specification parameters and/or limits of an excipient
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 31 — official PDF, p. 42 ↗
| Variant | Change | Type |
|---|---|---|
| a | Tightening of specification limits | Type IA |
| b | Addition of a new specification parameter to the specification | Type IA |
| c | Change outside the approved specifications limits range | Type II |
| d | Deletion of a specification parameter which may have a significant effect on the overall quality of the finished product | Type II |
| e | Addition or replacement (excluding biological or immunological product) of a specification parameter parameter with its corresponding test method, as a result of a safety or quality issue | Type IB |
| f | Deletion of a non-significant specification parameter (e. g deletion of an obsolete test e.g. organoleptic test) | Type IA |
| g | a change in specification from in-house to a non-official Pharmacopoeia | Type IB |
Conditions to be fulfilled and documentation to be supplied: see the official guideline, item 31.
EU European Union
Commission Guidelines C/2025/5045 — EUR-Lex ↗
Q.II.c.1 · Change in the specification attribute and/or acceptance criteria of an excipient
| Variant | Change | Type |
|---|---|---|
| a | Change within the approved specification acceptance criteria | Type IA |
| b | Addition of a new specification attribute to the specification with its corresponding analytical procedure | Type IA |
| c | Deletion of a non-significant or obsolete specification attribute | Type IA |
| d | Change outside of the approved specification acceptance criteria | Type II |
| e | Deletion of a specification attribute which may have a significant effect on the overall quality of the finished product | Type II |
| f | Change in specification of an excipient from in-house to a non-official Pharmacopoeia/Pharmacopoeia of a third country where there is no monograph in the European Pharmacopoeia or the national pharmacopoeia of a Member State | Type IB |
| g | Replacement of a specification attribute with its corresponding analytical procedure | Type IB |
US FDA US Food and Drug Administration
21 CFR 314.70 and FDA guidance — 2004 Guidance §VIII.B–D · 2014 AR Guidance App. A 4.1, 4.9 · 21 CFR 314.70(b)(2)(i), (c)(2)(iii)
| Change | Category | Reference |
|---|---|---|
| Tightening of an excipient acceptance criterion | Annual report | 2014 App. A 4.9; 2004 §VIII.D.3 |
| Addition of a new test to the excipient specification | Annual report | 2014 App. A 4.1 |
| Relaxing a criterion or deleting a test solely to comply with USP/NF | CBE-30 supplement | 21 CFR 314.70(c)(2)(iii); 2004 §VIII.C.1.e |
| Relaxing an excipient acceptance criterion or deleting a test (any significance) | Prior approval supplement | 2004 §VIII.B.1–2; 21 CFR 314.70(b)(2)(i) |
Note: FDA has no separate category for deleting a non-significant test: deleting even an obsolete excipient test is PAS unless done to comply with USP/NF (CBE-30, 314.70(c)(2)(iii)). Moving from an in-house to a non-USP pharmacopoeial standard is classified by net effect (tightening or addition AR; any relaxation or deletion PAS), since the official compendium is USP/NF.
Other items in II.2 Finished product c) Control of excipients
- 32 · Change in test procedure for an excipient
- 33 · Change in source of an excipient or reagent with TSE risk
- 34 · Change in supplier of an excipient or reagent without 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.