SFDA item 18 · II. Quality changes · II.1 Active substance c) Container closure system
Change in test procedure for the immediate packaging of the active substance
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 18 — official PDF, p. 27 ↗
| Variant | Change | Type |
|---|---|---|
| a | Minor changes to an approved test procedure | Type IA |
| b | Other changes to a test procedure (including replacement or addition) | Type IA |
| c | 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 18.
EU European Union
Commission Guidelines C/2025/5045 — EUR-Lex ↗
Q.I.c.3 · Change in analytical procedure for the immediate packaging of the active substance
| Variant | Change | Type |
|---|---|---|
| a | Minor change to an approved analytical procedure | Type IA |
| b | Other change to an analytical procedure (including replacement or addition) | Type IA |
| c | Deletion of an analytical procedure if an alternative procedure is already authorised | Type IA |
US FDA US Food and Drug Administration
21 CFR 314.70 and FDA guidance — 2004 Guidance §VIII.B.5, §VIII.C.2.b · 21 CFR 314.70(d)(2)(vii)
| Change | Category | Reference |
|---|---|---|
| Adding, revising or deleting an alternative procedure of equal or greater assurance | Annual report | 21 CFR 314.70(d)(2)(vii) |
| Change or replacement of a packaging-component test procedure with equal or greater assurance | CBE-0 supplement | 2004 §VIII.C.2.b |
| Packaging-component procedure change that lowers assurance | Prior approval supplement | 2004 §VIII.B.5 |
Note: Under 2004 §VIII.C.2.b even minor method edits for packaging components are CBE-0. A minor edit that keeps the methodology could be argued as AR by analogy to 2014 App. A 4.3, but that example is written for drug substance and drug product methods.
Other items in II.1 Active substance c) Container closure system
- 16 · Change in immediate packaging of the active substance
- 17 · Change in the specification parameters and/or limits of the immediate packaging of the active substance
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.