SFDA item 32 · II. Quality changes · II.2 Finished product c) Control of excipients
Change in test procedure for 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 32 — official PDF, p. 43 ↗
| Variant | Change | Type |
|---|---|---|
| a | Minor changes to an approved test procedure | Type IA |
| b | Change (including replacement or addition) to a biological/immunological/immunochemical test method or a method using a biological reagent | Type II |
| c | Other changes to a test procedure (including replacement or addition) | Type IB |
| d | Deletion of a test procedure if an alternative test procedure is already authorized | Type IA |
Conditions to be fulfilled and documentation to be supplied: see the official guideline, item 32.
EU European Union
Commission Guidelines C/2025/5045 — EUR-Lex ↗
Q.II.c.2 · Change in analytical procedure for an excipient
| Variant | Change | Type |
|---|---|---|
| a | Minor change to an approved analytical procedure | Type IA |
| b | Deletion of an analytical procedure if an alternative analytical procedure is already authorised | Type IA |
| c | Introduction, replacement or substantial change to a biological/immunological/immunochemical analytical procedure for an excipient | Type II |
| d | Other changes to an analytical procedure (including replacement or addition) | Type IB |
US FDA US Food and Drug Administration
21 CFR 314.70 and FDA guidance — 2004 Guidance §VIII.B.5–6, §VIII.C.2.b · 2014 AR Guidance App. A 4.3 · 21 CFR 314.70(d)(2)(vii)
| Change | Category | Reference |
|---|---|---|
| Minor edit keeping the original methodology, equivalent or better assurance, criteria unchanged (e.g., HPLC flow rate) | Annual report | 2014 App. A 4.3 |
| Add, revise or delete an alternative procedure giving the same or increased assurance | Annual report | 21 CFR 314.70(d)(2)(vii) |
| Other change or replacement of a component test procedure giving the same or increased assurance | CBE-0 supplement | 2004 §VIII.C.2.b |
| Change giving reduced assurance (e.g., HPLC no longer resolving impurities), incl. virus/adventitious-agent tests on raw materials | Prior approval supplement | 2004 §VIII.B.5–6 |
Note: Biological or bioassay methods for excipients have no NDA-specific rule: the same-or-increased-assurance test decides CBE-0 vs PAS, and reduced-assurance changes to virus/adventitious-agent testing of raw materials are PAS (§VIII.B.6). BLA products follow 21 CFR 601.12.
Other items in II.2 Finished product c) Control of excipients
- 31 · Change in the specification parameters and/or limits of 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.