SFDA item 26 · II. Quality changes · II.2 Finished product b) Manufacture
Replacement or addition of a manufacturing site for part or all of the manufacturing process 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 26 — official PDF, p. 34 ↗
| Variant | Change | Type |
|---|---|---|
| a | Secondary packaging site | Type IA(IN) |
| b | Primary packaging site | Type IA(IN) |
| c | Site where any manufacturing operation(s) take place, except batch release, batch control and secondary packaging, for sterile medicinal products (including those that are aseptically manufactured), biological/ immunological medicinal products, or for pharmaceutical forms manufactured by complex manufacturing processes | Type II |
| d | Site where any manufacturing operation(s) take place, except batch-release, batch control primary and secondary packaging, for non-sterile medicinal products. | Type IB |
| e | Site, which requires an inspection by SFDA. | Type II |
Conditions to be fulfilled and documentation to be supplied: see the official guideline, item 26.
EU European Union
Commission Guidelines C/2025/5045 — EUR-Lex ↗
Q.II.b.1 · Change in the manufacturing site for part or all of the manufacturing process of the finished product (except for batch release and batch control testing sites)
| Variant | Change | Type |
|---|---|---|
| a | Addition or replacement of a site responsible for secondary packaging | Type IA(IN) |
| b | Addition or replacement of a site responsible for immediate packaging | Type IA(IN) |
| c | Addition or replacement of a site responsible for any manufacturing operation(s) of finished product manufactured by novel or complex manufacturing processes | Type II |
| d | Addition or replacement of a site which requires an initial or product specific GMP inspection | Type II |
| e | Addition or replacement of a site responsible for any manufacturing operation(s) of a finished product | Type IB |
| f | Addition or replacement of a site responsible for the assembly of a finished product containing an integral medical device | Type IB |
US FDA US Food and Drug Administration
21 CFR 314.70 and FDA guidance — 2004 Guidance §VI (A–D), Att. A–B · 2014 AR Guidance App. B 2.1 · 21 CFR 314.70(b)–(d)
| Change | Category | Reference |
|---|---|---|
| Relocation within the same site (same registration and FDA district; contiguous site if foreign) with no other change | Not reportable | 2004 §VI.A; Att. A |
| Different site for secondary packaging or labeling (site has satisfactory CGMP status) | Annual report | 2014 App. B 2.1.1; 2004 §VI.D.1–2 |
| Different site for primary packaging (non-dose-controlling products, including modified-release solid orals) | CBE-30 supplement | 2004 §VI.C.1.c |
| Different site for manufacture/processing of a conventional drug product; aseptic product moved to an existing aseptic area already making similar products | CBE-30 supplement | 2004 §VI.C.1.a–b |
| Manufacture of modified-release, transdermal, liposomal or depot products, or manufacture/primary packaging of dose-controlling products (MDI, DPI, nasal pumps); aseptic product to a new, refurbished or dissimilar aseptic area; terminally sterilized product to a newly built facility | Prior approval supplement | 2004 §VI.B.3–5 |
| New site never FDA-inspected or without a satisfactory CGMP inspection for the type of operation, or restart of an operation discontinued for more than two years | Prior approval supplement | 2004 §VI.B.1–2; Att. B |
Note: A new site without a satisfactory CGMP inspection for the type of operation is PAS, overriding lower categories (§VI.C–D preambles); a move combined with process or equipment changes takes the most restrictive category (§XII). Within a site, aseptic moves are CBE-30 (§VI.C.1.b), and 2014 App. B 2.1.2 lists other same-site relocations, including terminal sterilization, as annual-report items.
Other items in II.2 Finished product b) Manufacture
- 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
- 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.