Site Recipe
A Site Recipe is the ISA-88 recipe level that carries product-and-process knowledge in a form that fits one specific site's capabilities — but does not yet bind to a specific line or equipment train. It sits between the General Recipe (product knowledge) and the Master Recipe (line-specific execution).
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In multi-site tech transfer and contract manufacturing it is the artefact that travels: the originating site authors it, the receiving site uses it to build its own Master Recipe against its own equipment, and the linkage between the two is what makes a tech-transfer audit defensible.
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01What a Site Recipe is
Per ISA-88.01 §5.4.3, a Site Recipe is "a recipe specific to a particular site". It inherits product knowledge from the General Recipe and adds whatever the site needs to make the product — local materials, local utilities, local regulatory constraints, local language — without yet committing to specific equipment.
- Product identity, target attributes, critical quality attributes (CQAs).
- Process knowledge — design space, critical process parameters (CPPs), known interactions.
- Site-specific material specifications — local supplier qualifications, local pharmacopoeial cross-references (USP vs EP vs JP).
- Site-specific regulatory annotations — labelling, language, expiry dating per market.
- Site-allowable unit classes — the families of equipment the site can offer (e.g. "jacketed reactor 1,000–3,000 L, CIP-capable").
- Reference IPC methods — not bound to a specific instrument yet.
02When you actually need a Site Recipe
Not every manufacturer needs all four ISA-88 recipe levels. The Site Recipe is genuinely useful when:
- A product is made at multiple sites (sponsor company with two plants; sponsor + CMO; multi-site CMO).
- A site makes multiple variants of the same product (different markets, different presentations).
- Tech transfer is a recurring activity rather than a one-off.
- Local raw-material sourcing or local regulatory constraints meaningfully change the recipe.
Single-product, single-site, single-line operations can collapse General → Site → Master into one document; ISA-88 explicitly allows this. The risk is that future expansion (new site, new market) requires retro-fitting the missing layers.
03Site Recipe in tech transfer
Tech transfer between sites (or sponsor → CMO) is where the Site Recipe is decisive. The originating site provides:
- The General Recipe (product knowledge) — the development package, CQAs, design space.
- Its own Site Recipe — how the originating site interprets the general recipe locally.
- Process-performance history — historical batch data, OOS frequency, deviation patterns.
The receiving site authors its own Site Recipe (its local materials, its language, its market labels) and then its own Master Recipe (bound to its specific equipment). The originating Site Recipe is reference; the receiving Site Recipe is execution-bound knowledge. ICH Q10 §3.2.3 expects this knowledge-management trail to be auditable.
04Site Recipe at a CMO
Contract manufacturers (CMOs and CDMOs) frequently make the same product type for multiple sponsors. Each sponsor has a different General Recipe, but the CMO's Site Recipe layer captures "how this CMO site executes any product of this class" — site SOPs, line-clearance protocols, environmental monitoring, sampling pattern. Without the Site Recipe layer, the CMO duplicates these decisions in every Master Recipe and risks inconsistency.
- Quality agreement (per 21 CFR 200 / ICH Q10) flows down to the Site Recipe — sampling, release authority, deviation handling.
- Sponsor signs off the Site Recipe; CMO owns the Master Recipe (because it owns the equipment).
- Change control on the Site Recipe triggers sponsor notification; change control on the Master Recipe is local to the CMO unless it touches the design space.
05Site Recipe lifecycle
- Draft — author drafts from the General Recipe or an existing Site Recipe.
- In Review — site technical lead + QA review.
- Approved — released for use as parent of Master Recipes.
- Superseded — replaced by a newer version; existing Master Recipes that descended from it remain valid until they too revise.
- Obsolete — product no longer made at this site.
A Site Recipe revision does NOT automatically revise descendant Master Recipes — that would invalidate validation. Instead, the revision triggers an impact assessment that decides whether each Master Recipe needs to follow.
06Common mistakes
- Skipping the Site Recipe layer and embedding site decisions in every Master Recipe — inconsistency across lines at the same site.
- Treating the Site Recipe as a marketing document, not an execution-relevant artefact — auditors cannot trace from CQA to control.
- Authoring a Site Recipe with equipment bound — collapses it into a Master Recipe and defeats the abstraction.
- Revising a Site Recipe without impact assessment on descendant Master Recipes.
- CMO uses sponsor's Master Recipe verbatim instead of authoring its own — equipment mismatches, no local validation.
- Sponsor-CMO Site Recipe ownership unclear — change control fails the next inspection.
07How V5 Ultimate handles Site Recipes
Frequently asked questions
Q.Do I have to use all four ISA-88 recipe levels?+
No. ISA-88.01 §5.4 explicitly allows collapsing levels when they add no value. A single-product, single-site, single-line operation can use just a Master Recipe. The risk is that future expansion requires retrofitting the missing layers, which is harder than starting with them.
Q.Who owns the Site Recipe in a sponsor-CMO relationship?+
It depends on the quality agreement. Most commonly the CMO authors the Site Recipe (because it owns site knowledge) and the sponsor approves it (because it owns product knowledge). V5's CMO module supports this dual-ownership pattern with separate sponsor and CMO sign-off slots.
Q.Does a Site Recipe need equipment information?+
Equipment classes yes, equipment instances no. "A jacketed reactor 1,000–3,000 L, CIP-capable" is allowed; "Reactor R-201" is not — that pins it to a line and collapses the abstraction.
Q.How does Site Recipe revision flow to Master Recipes?+
It does not flow automatically. Each descendant Master Recipe is impact-assessed; the Master Recipe owner decides whether to revise. This preserves the validation lineage of unaffected Master Recipes and avoids forcing re-validation across the whole plant.
Q.Is a Site Recipe required by FDA or EMA?+
Neither cites it by name — they cite the master production record (21 CFR 211.186) and process description (Annex 15). But the ISA-88 hierarchy is the de-facto framework that makes those records auditable across sites, and tech-transfer guidance (ICH Q10, ISPE Tech Transfer Guide) assumes the layered model.
Primary sources
Further reading
Want to see how Site Recipe could fit into your own records and workflows? Explore the related V5 pages or talk to our team about what applies to your operation.