SFDA item 37 · II. Quality changes · II.2 Finished product d) Control of finished product
Change in test procedure for 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 37 — official PDF, p. 47 ↗
| Variant | Change | Type |
|---|---|---|
| a | Minor changes to an approved test procedure. | Type IA |
| b | Substantial change to, or replacement of, a biological/immunological/immunochemical test method or a method using a biological reagent or replacement of a biological reference preparation | Type II |
| c | Other changes to a test procedure (including replacement or addition). | Type IB |
| d | Deletion of a test procedure if an alternative method is already authorized. | Type IA |
| e | Update of the test procedure to comply with the updated monograph in an official pharmacopeia. | Type IA |
| f | To reflect compliance with the official pharmacopeia and remove reference to the outdated internal test method and test method number | Type IA |
Conditions to be fulfilled and documentation to be supplied: see the official guideline, item 37.
EU European Union
Commission Guidelines C/2025/5045 — EUR-Lex ↗
Q.II.d.2 · Change to analytical procedure for the finished product
| Variant | Change | Type |
|---|---|---|
| a | Minor change to an approved analytical procedure | Type IA |
| b | Deletion of an analytical procedure if an alternative procedure is already authorised | Type IA |
| c | Introduction, replacement, or substantial change to a biological/immunological/immunochemical analytical procedure for a finished product | Type II |
| d | Other change to an analytical procedure for a finished product (including replacement or addition) | Type IB |
| e | Update of the analytical procedure to comply with the updated general monograph in the Ph. Eur. | Type IA |
| f | To reflect compliance with the Ph. Eur. and remove reference to the outdated internal analytical procedure and analytical procedure number | Type IA |
US FDA US Food and Drug Administration
21 CFR 314.70 and FDA guidance — 2004 Guidance §VIII.B.3–4, §VIII.C.1.a, §VIII.D.1–2, §XI.C.4 · 2014 AR Guidance App. A 4.3 · 21 CFR 314.70(d)(2)(i), (d)(2)(vii)
| Change | Category | Reference |
|---|---|---|
| Minor edit keeping the original methodology, equivalent or better assurance, criteria unchanged (e.g., HPLC flow rate, sample prep) | Annual report | 2014 App. A 4.3 |
| Add, revise or delete an alternative analytical procedure | Annual report | 2004 §VIII.D.2; 21 CFR 314.70(d)(2)(vii) |
| Procedure change made to comply with USP/NF (incl. replacing an outdated in-house method by the compendial one) | Annual report | 2004 §VIII.D.1; 21 CFR 314.70(d)(2)(i) |
| Replacement of an in-house (non-USP) reference standard per the approved procedure | Annual report | 2004 §XI.C.4 |
| Any other modification of the regulatory analytical procedure (not major, not editorial) | CBE-30 supplement | 2004 §VIII.C.1.a |
| New regulatory procedure (replacement, or promoting an alternative to regulatory) or a change giving reduced assurance | Prior approval supplement | 2004 §VIII.B.3–4 |
Note: Replacing the regulatory method means establishing a new regulatory analytical procedure (PAS, §VIII.B.3); modifying the existing one is CBE-30 (§VIII.C.1.a) and same-methodology edits are AR (2014 App. A 4.3). USP/NF procedures are the regulatory procedures for compendial items (§VIII.A), but compendial changes touching assay or impurity tests need a supplement (2014 App. A 4.2).
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
- 38 · Variations related to the introduction of real-time release or parametric release in the manufacture of 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.