Designed to pass inspection.
Compliance is not a checkpoint at the end. It is engineered in from the first layout. Every design decision we make is traceable to a requirement, and every requirement is verifiable at handover.
How compliance is engineered in
The basis of design
Every project is anchored in a basis of design. Starting from the user requirement specification and a formal risk assessment, we set out the intended process, area classification, HVAC and pressure regime, utility qualities and the regulatory standards that govern each — creating a single, traceable reference that ties every downstream drawing back to a stated requirement.
Design review & GMP advisory
Independent, structured review of facility and equipment design against GMP, ISPE and regulatory expectations — catching compliance gaps while they are still inexpensive to fix.
Designed for your market
EMA, US FDA, WHO prequalification, PIC/S, GCC or Saudi FDA — we design to the regulator you answer to, and where a project targets several markets, to the most stringent requirement. Standards are applied to the edition current at the time of design.
The regulators behind your markets
Key regulators behind the markets our clients supply, with the global guidance we apply on every project.
- US FDAUnited States
- EU GMP – EMAEuropean Union
- Jordan FDAJordan
- GCC GMP – Saudi FDAGulf & Saudi Arabia
Applied globally, on every project
The frameworks we design to
| Framework | Scope |
|---|---|
| GMP | EU, PIC/S, WHO and regional GMP |
| FDA / EMA | US FDA and European EMA expectations |
| GCC / SFDA | Gulf and Saudi FDA requirements |
| Annex 1 | Sterile product manufacture |
| ISO 14644 | Cleanroom classification |
| ISPE | Baseline and Good Practice Guides |
| Data integrity | ALCOA+ · 21 CFR Part 11 |
Compliance is not a checkpoint at the end; it is designed in from the first layout. We design to the regulator each facility must answer to, and where a project targets several markets, to the most stringent requirement.
The rules we build by.
A pharmaceutical facility is only as sound as the standards behind it. We work fluently across the regulations and industry guidance that govern pharmaceutical manufacturing worldwide, and design each facility to satisfy the specific markets and regulators it must answer to.
01
GMP regulations
The core good manufacturing practice frameworks we design and review against:
02
Sterile & annexes
Guidance governing sterile manufacture, cleanrooms and specialised processes:
03
Engineering & good practice
The engineering guidance that shapes how we design:
04
Quality, data & distribution
The harmonised quality, data-integrity and supply-chain standards we apply:
Applying the standards
How we apply them
We don’t treat guidelines as a checklist bolted on at the end. Each requirement is traced from the user requirement specification through design and into qualification, so the finished facility carries documented evidence of conformance, ready for inspection from day one.
Designed for your market
Facilities are engineered to the specific regulator you answer to — whether that’s EMA, US FDA, WHO prequalification, PIC/S or the GCC and Saudi FDA.
Standards are applied to the edition and revision current at the time of design. Where a project targets multiple markets, we design to the most stringent applicable requirement.
Let’s design it right.
From the first concept sketch to an issued-for-construction package, Agon designs pharmaceutical facilities that meet the highest international standards. We would welcome the conversation.