Your facility passes the inspection. First time.
Pharmaceutical manufacturing is unforgiving. A single failed EU GMP inspection can halt production, trigger recalls, and cost years of remediation. We build EPCM projects where regulatory compliance isn't a final check but the foundation everything is designed around.
Most pharmaceutical inspection findings trace back to engineering decisions made earlier in the project. Here is where those risks sit — and how we design them out.
| ⚠️ Issue | Root cause | ✅ Our response | Standard |
|---|---|---|---|
| Qualification lifecycle gaps | URS doesn't trace to FAT protocols. IQ executed without DS reference. OQ parameters not derived from FDS. | V-model structured from day one — every qualification document is evidence of something that was tested, not assembled retrospectively | EU GMP |
| Cleanroom design errors | Grade boundaries that fail under operational pressure. Airlocks that don't cascade. Gowning routes that create contamination vectors. | Cleanrooms designed for how they will be operated — operators in the design session, not just engineers. Pressure cascades and gowning routes verified at design stage. | ISO 14644 |
| Computer system validation drift | Suppliers install SCADA/DCS without GAMP 5 understanding. URS defined after configuration. CSV assembled retrospectively. | CSV managed prospectively from URS — SCADA, DCS, MES, LIMS validated under GAMP 5 before go-live, not for the inspector | GAMP 5 |
| FAT/SAT disconnected from qualification | Factory tests generate no IQ evidence. SAT protocols written after FAT is complete. Documentation rebuilt for inspectors. | FAT protocols written to serve as IQ/OQ evidence — reduces total test time by weeks and eliminates retrospective documentation work | EU GMP |
| Change control not designed in | Facilities not designed with change control in mind cost significantly more to manage — document trails break on first modification. | Document hierarchies, drawing revision controls, and as-built capture built into the initial engineering scope — not retrofitted | EU GMP |
| Procurement without regulatory visibility | Equipment purchased without DQ. Suppliers selected without GMP assessment. Timelines ignore vendor qualification. | Pharmaceutical procurement managed with the qualification lifecycle in view from first specification — DQ before purchase order, not after delivery | FDA / EMA |
Whether you're a CDMO running continuous qualification programmes, a mid-size manufacturer upgrading facilities, or a scale-up commissioning your first GMP suite and our approach adapts to your regulatory context and project scale.
Ongoing qualification, new suite fit-outs, CSV for multi-product platforms
Facility upgrades, EU GMP compliance, solid dose and liquid manufacturing
First GMP facility, VMP development, cleanroom engineering from scratch
Containment engineering, ATEX, cGMP API process plant, HAZOP support
Three ETPs across BSL2/BSL3 boundaries. First shredder-autoclave at a pharmaceutical site. 100% regulatory decontamination compliance on commissioning.
High-purity gas network inside a live cleanroom. Full off-site prefabrication certified before site entry. Zero in-cleanroom fabrication.
The V-model isn't just a regulatory requirement but a project management tool. When it's done correctly, every qualification protocol is the mirror image of a design specification. Nothing is tested without a requirement. Nothing passes without traceability.
| URS | → | validates | → | PQ |
| FDS | → | validates | → | OQ |
| DS | → | validates | → | IQ |
| FAT → SAT | ||||
C2Improve writes FAT and SAT protocols that are directly traceable to the FDS and DS. This means FAT evidence is IQ/OQ evidence and tested once, not twice. For a typical equipment qualification, this saves 4–8 weeks of repeat testing and documentation.