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 |
We work with CDMOs, generic manufacturers, biotech scale-ups, and API & specialty pharma producers — adapting to your regulatory context and project scale.
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.
We write FAT and SAT protocols traceable directly to the FDS and DS — so FAT evidence becomes IQ/OQ evidence. Tested once, not twice. For a typical equipment qualification, this saves 4–8 weeks of repeat testing and documentation. See the full V-model →