SFDA item 30 · II. Quality changes · II.2 Finished product b) Manufacture
Change to in-process tests or limits applied during 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 30 — official PDF, p. 40 ↗
| Variant | Change | Type |
|---|---|---|
| a | Tightening of in-process limits | Type IA |
| b | Addition of a new tests and limits | Type IA |
| c | Widening of the approved IPC limits, which may have a significant effect on the overall quality of the finished product | Type II |
| d | Deletion of an in-process test which may have a significant effect on the overall quality of the finished product | Type II |
| e | Addition or replacement of an in-process test as a result of a safety or quality issue | Type IB |
| f | Deletion of a non-significant in-process test | Type IA |
Conditions to be fulfilled and documentation to be supplied: see the official guideline, item 30.
EU European Union
Commission Guidelines C/2025/5045 — EUR-Lex ↗
Q.II.b.5 · Change to in-process control or limits applied during the manufacture of the finished product
| Variant | Change | Type |
|---|---|---|
| a | Minor changes of in-process control limits | Type IA |
| b | Addition of new in-process control and limits with its corresponding analytical procedure | Type IA |
| c | Deletion of a non-significant or obsolete in-process control | Type IA |
| d | Deletion of an in-process control which may have a significant effect on the overall quality of the finished product | Type II |
| e | Widening of the approved in-process control limits, which may have a significant effect on overall quality of the finished product | Type II |
| f | Change of an analytical procedure for an in-process control | Type IA |
| g | Replacement of an in-process control 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 4.5–4.7, 4.9 · 21 CFR 314.70(b)(2)(i)
| Change | Category | Reference |
|---|---|---|
| Tightening of an in-process acceptance criterion | Annual report | 2014 App. A 4.9; 2004 §VIII.D.3 |
| Addition of an in-process test | Annual report | 2014 App. A 4.5 |
| Replacing an in-process test procedure with one giving the same or increased assurance | CBE-0 supplement | 2004 §VIII.C.2.b |
| Relaxing an in-process microbiological monitoring limit (environment, bioburden before filtration) | CBE-30 supplement | 2004 §VIII.C.1.d |
| Relaxing any other in-process limit, or deleting an in-process 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 in-process test: deletion is PAS unless a listed AR case applies, i.e. replacing blend-uniformity/homogeneity tests with other adequate mix testing (2014 App. A 4.6) or revising tablet hardness with dissolution unchanged (App. A 4.7).
Other items in II.2 Finished product b) Manufacture
- 26 · Replacement or addition of a manufacturing site for part or all of the manufacturing process of the finished product
- 27 · Change to batch release arrangements and quality control testing of the finished product
- 28 · Change in the manufacturing process of the finished product
- 29 · Change in the batch size (including batch size ranges) 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.