SFDA item 27 · II. Quality changes · II.2 Finished product b) Manufacture
Change to batch release arrangements and quality control testing 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 27 — official PDF, p. 35 ↗
| Variant | Change | Type |
|---|---|---|
| a | Replacement or addition of a site where batch control/testing takes place | Type IA(IN) |
| b | Replacement or addition of a site where batch control/testing takes place for a biological/immunological product and any of the test methods performed at the site is a biological/immunological method | Type II |
| c.1 | Replacement or addition of a manufacturer responsible for batch release — Not including batch control/testing | Type IA(IN) |
| c.2 | Replacement or addition of a manufacturer responsible for batch release — Including batch control/testing | Type IA(IN) |
| c.3 | Replacement or addition of a manufacturer responsible for batch release — Including batch control/testing for a biological/immunological product and any of the test methods performed at the site is a biological/immunological method | Type II |
Conditions to be fulfilled and documentation to be supplied: see the official guideline, item 27.
EU European Union
Commission Guidelines C/2025/5045 — EUR-Lex ↗
Q.II.b.2 · Change to batch release arrangements and batch control testing of the finished product
| Variant | Change | Type |
|---|---|---|
| a | Addition or replacement of a batch control/testing site applying physicochemical and/or microbiological analytical procedures for the finished product | Type IA |
| b | Addition or replacement of a batch control/testing site applying a biological/immunological/immunochemical analytical procedure for a biological finished product | Type IB |
| c.1 | Addition or replacement of a site responsible for batch release (QP certification) — Not including batch control/testing | Type IA(IN) |
| c.2 | Addition or replacement of a site responsible for batch release (QP certification) — Including batch control/testing applying physicochemical and/or microbiological analytical procedures for the finished product | Type IA(IN) |
| c.3 | Addition or replacement of a site responsible for batch release (QP certification) — Including batch control/testing applying a biological/immunological/immunochemical analytical procedure for a biological finished product | Type IB |
US FDA US Food and Drug Administration
21 CFR 314.70 and FDA guidance — 2004 Guidance §VI.A, §VI.C.1.d, Att. B · 21 CFR 314.70(c)
| Change | Category | Reference |
|---|---|---|
| Change of the entity that only certifies or releases batches (no testing): US applications name no separate batch-release site | No US equivalent | |
| Different testing lab using approved (or AR-implemented) methods, commitments fulfilled, lab capable; same category for all NDA product types | CBE-30 supplement | 2004 §VI.C.1.d; §VI.A |
| New testing lab without a satisfactory FDA CGMP inspection (never inspected or unacceptable status) | Prior approval supplement | 2004 §VI.C (preamble); §VI.B.1–2; Att. B |
Note: Batch disposition is a CGMP quality-unit function (21 CFR 211.22), not a separately registered release site, so a change of releasing entity needs no separate filing. Testing-site risk is independent of dosage form (§VI.A), so NDA labs running biological methods are also CBE-30 (BLAs follow 21 CFR 601.12). Method changes at the new lab are classified separately under §VIII.
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
- 28 · Change in the manufacturing process of the finished product
- 29 · Change in the batch size (including batch size ranges) of the finished product
- 30 · Change to in-process tests or limits applied during 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.