SFDA item 36 · II. Quality changes · II.2 Finished product d) Control of finished product
Change in the specification parameters and/or limits 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 36 — official PDF, p. 46 ↗
| 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 | Change outside the approved specifications limits range | Type II |
| d | Deletion of a specification parameter which may have a significant effect on the overall quality of the finished product | Type II |
| e | Addition or replacement (excluding biological or immunological product) of a specification parameter with its corresponding test method as a result of a safety or quality issue | Type IB |
| f | Deletion of a non-significant specification parameter (e. g deletion of an obsolete parameter such as odour and taste or identification test for a colouring or flavouring material) | Type IA |
| g | Update of the dossier to comply with the provisions of an updated monograph of an official pharmacopeia for the finished product | Type IA |
Conditions to be fulfilled and documentation to be supplied: see the official guideline, item 36.
EU European Union
Commission Guidelines C/2025/5045 — EUR-Lex ↗
Q.II.d.1 · Change in the specification attribute and/or acceptance criteria of the finished product
| Variant | Change | Type |
|---|---|---|
| a | Change within the specifications acceptance criteria | Type IA |
| b | Change within the specification acceptance criteria for finished products subject to Official Control Authority Batch Release | Type IA(IN) |
| c | Addition of a new specification attribute with its corresponding analytical procedure and acceptance criteria | Type IA |
| d | Deletion of a non-significant or obsolete specification attribute (e.g. deletion of odour and taste or identification test for a colouring or flavouring material) | Type IA |
| e | Change outside of the specification acceptance criteria of the finished product | Type II |
| f | Deletion of a specification attribute which may have a significant effect on the overall quality of the finished product | Type II |
| g | Update of the dossier to comply with the provisions of an updated general monograph of the Ph. Eur (*2). | Type IA(IN) |
| h | Ph. Eur. 2.9.40 Uniformity of dosage units is introduced to replace the currently registered method, either Ph. Eur. 2.9.5 (Uniformity of mass) or Ph. Eur. 2.9.6 (Uniformity of content) | Type IA |
| i | Change in the testing of specification attribute, from routine to skip/periodic testing and vice versa | Type IB |
| j | 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–D · 2014 AR Guidance App. A 4.2, 4.4, 4.9 · 21 CFR 314.70(b)(2)(i), (c)(2)(iii), (c)(6)(i), (d)(2)(i)
| Change | Category | Reference |
|---|---|---|
| Tightening of a drug product acceptance criterion | Annual report | 2014 App. A 4.9; 2004 §VIII.D.3 |
| Change to comply with USP/NF that neither relaxes a criterion nor deletes a test | Annual report | 2014 App. A 4.2; 21 CFR 314.70(d)(2)(i) |
| Addition of a new test with its procedure and acceptance criterion | CBE-0 supplement | 2004 §VIII.C.2.a; 21 CFR 314.70(c)(6)(i) |
| Relaxing a criterion or deleting a test to comply with USP/NF | CBE-30 supplement | 2004 §VIII.C.1.e; 21 CFR 314.70(c)(2)(iii) |
| Relaxing an acceptance criterion or deleting any test | Prior approval supplement | 2004 §VIII.B.1–2; 21 CFR 314.70(b)(2)(i) |
Note: FDA has no separate category for deleting a non-significant test: removing even an obsolete test (e.g., odour) is PAS unless compendial (CBE-30), while replacing a nonspecific identity test with a discriminating one is AR (2014 App. A 4.4). Compendial updates touching assay, impurity/degradant or biological-activity tests need a supplement (2014 App. A 4.2).
Other items in II.2 Finished product d) Control of finished product
- 37 · Change in test procedure for 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.