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.
Qualification & CQV
DQ, IQ, OQ and PQ protocols and execution for process equipment, HVAC and water systems, carrying the facility from mechanical completion to a released, inspection-ready state.
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 |
Agon integrates its engineering and compliance teams from project start, so the people drawing the facility and the people validating it share one understanding of the requirements.
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, commission and qualify:
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 build it right.
From the first concept sketch to a qualified, inspection-ready plant, Agon partners with pharmaceutical manufacturers to engineer facilities that meet the highest international standards. We would welcome the conversation.