SFDA item 17 · II. Quality changes · II.1 Active substance c) Container closure system
Change in the specification parameters and/or limits of 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 17 — official PDF, p. 26 ↗
| Variant | Change | Type |
|---|---|---|
| a | Tightening of specification limits | Type IA |
| b | Addition of a new specification parameter to the specification with its corresponding test method | Type IA |
| c | Addition or replacement of a specification parameter as a result of a safety or quality issue | Type IB |
| d | Deletion of a non-significant specification parameter (e.g. deletion of an obsolete test) | Type IA |
Conditions to be fulfilled and documentation to be supplied: see the official guideline, item 17.
EU European Union
Commission Guidelines C/2025/5045 — EUR-Lex ↗
Q.I.c.2 · Change in the specification attribute and/or acceptance criteria of the immediate packaging of the active substance
| Variant | Change | Type |
|---|---|---|
| a | Change of 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 | 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.2, §VIII.D.3, §IX.A · 2014 AR Guidance App. A 4.8 · 21 CFR 314.70(b)(2)(i)
| Change | Category | Reference |
|---|---|---|
| Tightening a packaging acceptance criterion | Annual report | 2004 §VIII.D.3 |
| Adding a packaging-material test for increased assurance | Annual report | 2014 App. A 4.8 |
| Deleting a packaging specification test, even an obsolete one | Prior approval supplement | 2004 §VIII.B.2; 21 CFR 314.70(b)(2)(i) |
Note: When the specification changes because the packaging changed, only the packaging change's category applies (§IX.A). Otherwise any deletion is PAS (§VIII.B.2); for a nonsterile drug substance container a lower category can only be justified under 314.70(d)(1) and should be confirmed with FDA. Drug substance packaging specifications often sit in the supplier's DMF.
Other items in II.1 Active substance c) Container closure system
- 16 · Change in immediate packaging of the active substance
- 18 · Change in test procedure for 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.