SFDA item 38 · II. Quality changes · II.2 Finished product d) Control of finished product
Variations related to the introduction of real-time release or parametric release in the manufacture of the finished product
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 38 — official PDF, p. 48 ↗
| Variant | Change | Type |
|---|---|---|
| - | Variations related to the introduction of real-time release or parametric release in the manufacture of the finished product | Type II |
EU European Union
Commission Guidelines C/2025/5045 — EUR-Lex ↗
Q.II.d.3 · Variations related to real-time release testing in the manufacture of the finished product
| Variant | Change | Type |
|---|---|---|
| - | Introduction, replacement, or substantial change of a real-time release testing procedure | Type II |
Note: Q.II.d.3 names real-time release testing only; EU guidance treats parametric release as a form of real-time release testing, so its introduction falls under the same item.
US FDA US Food and Drug Administration
21 CFR 314.70 and FDA guidance — 21 CFR 314.70(b)(2)(i), (b)(2)(iii), (e) · 2004 Guidance §VIII.A–B (by analogy)
| Change | Category | Reference |
|---|---|---|
| Real-time release testing replacing approved end-product release tests | Prior approval supplement | 2004 §VIII.B.2–3; 21 CFR 314.70(b)(2)(i) |
| Parametric release (sterility test replaced by process data) for a terminally sterilized product | Prior approval supplement | 21 CFR 314.70(b)(2)(iii); 2004 §VIII.A |
Note: The 2004 and 2014 guidances do not name real-time release testing or parametric release; both remove or replace approved end-product release tests (specification deletion or new regulatory procedure, PAS), and parametric release also bears on sterility-assurance specifications (§VIII.A). An approved comparability protocol (itself a PAS, 314.70(e)) can lower the category of later related changes.
Other items in II.2 Finished product d) Control of finished product
- 36 · Change in the specification parameters and/or limits of the finished product
- 37 · Change in test procedure for the finished product
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.