Compliant by Design

The GMP Facility Brief You Hand Your Architect

By Andrew Samann · Intrepid Scientific · 2026-06-25

Companion pieces: Built to Be Qualified (making equipment EU-GMP-suitable) · ICH Is the Bridge to EU GMP · EU GMP vs. FDA GMP.

0. Read-Me-First Summary

The most expensive way to build a GMP facility is the most common one: design the building first — hire the architect, approve a floor plan, pour concrete — and then try to bolt compliance on afterward. By the time a quality consultant or an inspector walks the finished space, the failures are physical. A corridor that lets clean and dirty flows cross. An airlock that was supposed to do two jobs and does neither. A room with a floor drain in the wrong place, ledges that collect dust, a pressure scheme that pushes contamination the wrong direction. Fixing those means re-cutting walls and re-balancing air after the build — the slowest, costliest, most morale-draining way to reach compliance.

There's a better first move, and it isn't a drawing. It's a User Requirements Specification (URS): a document-controlled brief that defines what the facility must do and satisfy — operationally, by quality, by regulation, by engineering — before anyone draws a wall. Done well, the URS makes the facility compliant by design: every room, every flow, every pressure cascade is traceable to a documented requirement, and the design is verifiable against it.

This piece is the URS-grade view of GMP facility design: what the document is, what goes in it, and why it must come before the architect rather than after. It deliberately stops where the next discipline begins — Design Qualification and commissioning — which is its own article.

1. The first deliverable is a specification, not a floor plan

EU GMP is explicit about the order of operations. Annex 15 — the EU's qualification-and-validation annex — frames facility delivery as a lifecycle that starts with the URS and flows through Design Qualification (DQ) into Installation, Operational, and Performance Qualification (IQ/OQ/PQ):

URS → DQ → IQ → OQ → PQ

The URS is the controlling input to everything downstream. It is the document that says, in advance and in writing, what "good" looks like — so that the design can be qualified against it, not argued about after the fact. Skip it, and you have no documented basis to accept or reject a design, a room, or a piece of equipment. You also have the single most common finding in a facility gap assessment: the absence of a design-linked validation strategy — a building that exists but can't prove it was built to a requirement.

So the first thing a serious GMP build produces is not a rendering. It's a specification.

2. What a URS actually is — the architect's brief

A facility URS is the brief you hand your architect. Not a vague wish list ("we want it GMP") — a structured, document-controlled requirement set the architect and the mechanical engineer can design to, and that the quality unit can later verify against. Its job is to make three things true:

Compliant by design. The layout, finishes, flows, and air scheme satisfy the regulatory bar as drawn, not after remediation.
Traceable. Every design decision — why this corridor is one-way, why this room is at +15 Pa, why these walls are coved — points back to a documented user need and a regulatory clause. Traceability is what turns "trust me" into "here's the requirement."
An acceptance basis. Every room, system, and product-contact item has a written acceptance criterion before construction is finalized — which is precisely what makes the later Design Qualification possible.

When the URS is good, the architect's job gets easier, not harder: they're designing against a clear target instead of guessing what the quality team will object to in six months.

3. The spine of a facility URS

A facility URS is more than a room list. The parts that actually drive compliance — and that an architect cannot infer on their own — are these:

A regulatory framework hierarchy. State the standards the facility must meet and the rule for conflicts: where requirements differ, the most stringent applies. A cannabis processor building for export, for instance, stacks the domestic production regulation, EU GMP (EudraLex Vol. 4 Chapters 3 and 5 for premises and cross-contamination), Annex 1 contamination-control principles applied to a non-sterile process, and ICH Q9 risk management as the basis for design trade-offs. The hierarchy is what stops "which rule wins?" from becoming a fight on the construction site.
A zoning matrix. Every room gets one defined zone classification — non-GMP, support, open-product, controlled storage, egress transition — and PPE and access rules follow the zone, not the job title. This single principle resolves a startling number of design questions, because once a room's zone is fixed, its finishes, pressure, gowning, and adjacencies largely follow.
Unidirectional personnel and material flow. The heart of contamination control is that clean and dirty never cross. The URS defines the GMP boundary (the exact doors where raw material becomes controlled), a single enforced personnel route (entry → change → gown → production), separate de-gowning egress so people don't exit the way product enters, and one-way material flow from raw through finished with reverse flow of open product prohibited. Waste and destruction routes are specified explicitly, because waste is how contamination walks backward through a building.
A material-state model. Define the discrete states the product moves through — fresh/raw, dried or in-process bulk, trimmed/finished bulk, sealed finished goods — and where the control tightens at each transition. The model is what tells the architect where the airlocks, the pressure steps, and the dedicated rooms have to be.
The engineering envelope. Pressure cascades (ΔP between adjacent rooms, so air always moves from cleaner to less-clean), HVAC ranges (temperature, humidity, air changes per hour, filtration grade), surfaces and finishes (epoxy floors with coved skirting, washable non-porous walls, smooth ceilings, no horizontal ledges that collect dust), lighting levels, sealed/fault-protected fixtures, drainage, and the environmental-monitoring infrastructure that will later prove the room performs.
Room-by-room requirements with acceptance criteria. Each room specified with the same field set: function, zone, max occupancy, surfaces, doors and interlocks, lighting, HVAC setpoints, EM limits, equipment, and cleaning. The acceptance criteria are the seeds of the DQ.
Design Change Recommendations. The punch list of specific changes the current/proposed layout needs to meet the above — this is the section that actually anchors the architect submission. It is where "the building must be compliant" becomes "move this wall, split this room, add this airlock, reverse this pressure."

4. Why it has to come before the architect

Two reasons, and both are about money and time.

First: construction-after-the-fact is the most expensive failure mode in GMP. Re-cutting a wall to add an airlock, re-running ductwork to fix a pressure cascade, or re-pouring a floor to add coving — after the build — costs multiples of getting it right on the drawing. "Compliant by design" isn't a slogan; it's the cheapest path to a facility that passes.

Second: the URS is what makes the design qualifiable at all. Without a documented requirement set, there is nothing to qualify the design against — and Design Qualification (the next phase) becomes impossible to do honestly. The URS is the contract between what the business needs, what the regulator requires, and what the architect draws.

This is just as true — often more true — for retrofits and expansions as for greenfield builds. Most cannabis and small-pharma operators aren't building from a clean sheet; they're expanding an existing block, working around fixed walls, existing utilities, and a live operation next door. A URS is what turns those constraints into a coherent, compliant design instead of a series of one-off compromises.

5. The hard part: a URS is walked, not typed

A URS written from a desk is fiction. The good ones are iterative and walked — drafted, then revised against the reality of the floor, the people, and the process. The first version captures intent; the second and third versions absorb what a site walkthrough with the quality lead and the operations director actually reveals. In practice that means the document changes shape as real constraints surface:

A single airlock that was meant to serve as both a material pass-through and a personnel de-gowning station turns out to do neither well — and gets replaced by separate, per-room egress.
A shared storage vault that has to be reachable from both a clean and a less-clean side creates a dual-access contradiction — and gets split into two physically separate rooms so no single room straddles two zones.
A corridor meant to run at one pressure needs two pressure tiers once you trace which rooms it actually fronts.
A drying or processing room's occupancy assumption collapses once you realize the trim crew belongs in a different room entirely — which changes its HVAC load, its EM limits, and its size.

None of that comes from a template. It comes from walking the space, interrogating the process, and revising the spec until the design is genuinely buildable and compliant. The deliverable that results — an approved layout plus a set of design-change recommendations — is the thing the client can carry into the architect's office with confidence.

6. Where this stops — and what comes next

Here is the deliberate boundary, and it's the same one a well-run engagement draws.

The URS plus its design-change recommendations gets you to an approved facility design and an architect's brief. That is the Phase-1 deliverable, and for a lot of operators it is exactly what they need first: a defensible, regulation-traceable design to hand to the architect and the mechanical engineer, so the drawings come back right the first time.

What it is not, yet, is Design Qualification. DQ is the formal, documented verification that the final design — the architect's actual drawings and the engineer's actual specifications — meets the URS, clause by clause. It is the gate between "we have a good brief" and "we have a qualified design we can build and then commission." DQ feeds directly into commissioning and the IQ/OQ/PQ sequence, and it carries its own discipline: traceability matrices, a DQ report, and sign-off that every URS requirement is satisfied by the design before a shovel moves.

That is the next article in this series: Design Qualification and commissioning — how you take an approved brief and turn it into a qualified, commissioned, inspection-ready facility. This piece ends where that one starts, on purpose.

How Intrepid Scientific helps

GMP facility design is one of the places a small mistake gets poured in concrete. We do the work that prevents it:

Facility URS authoring — the document-controlled, regulation-traceable requirement set you hand your architect: zoning matrix, personnel and material flow, pressure cascades, finishes, room-by-room acceptance criteria, and the design-change recommendations that anchor the architect submission.
Layout review against GMP principles — walking an existing or proposed layout and identifying the cross-contamination, flow, and segregation problems before they're built.
The path to Design Qualification — structuring the URS so the design can be formally qualified (DQ) and the facility can move cleanly into commissioning and IQ/OQ/PQ.

We author and structure; your architect and engineers design; we help you qualify. Phased and decision-gated — a scoped first stage gets you the brief, and you decide what comes next. See the Design Qualification + Commissioning Program and the EU GMP hub.

Building or expanding a GMP facility — and want it compliant by design, not remediated later? Talk to us about a facility URS → Senior scientists, direct engagement.

About the Author

Andrew Samann is a Cofounder of Intrepid Scientific. Recognized as a Processing Pro on The Cannabis Scientist's Power List for 2021 and 2022, Andrew has led over 100 GMP and quality-system engagements across North America, South America, and the European Union — including facility design, design qualification, and commissioning work under EU GMP Annex 15. As an ICH Q7 lead auditor for SGS North America he audited active-substance and finished-product manufacturers to the global cGMP standard. He led the ASTM D37.02 Quality Management Systems Subcommittee for Cannabis and is also Founder & CEO of Orion GMP Solutions.

About Intrepid Scientific

Intrepid Scientific is an independent scientific consulting firm offering ISO/IEC 17025 lab accreditation readiness, GMP and cGMP compliance, facility design and qualification, analytical method development and validation, microbiology and environmental monitoring, equipment-manufacturer (OEM) GMP documentation, expert witness, and Federal Pathway / Schedule III advisory across cannabis, hemp, food and beverage, pharmaceutical, dietary-supplement, and equipment-manufacturer clients. Senior scientists. Direct engagement.

Cofounders: Andrew Samann; Kate Evans, PhD; Tess Eidem, PhD; Julie Kowalski, PhD.

Learn more at intrepidscientific.com.