Consulting
Project management
Planning and coordination for GMP-related projects, from quality-system upgrades to remediation programmes.
Learn moreConsulting
Facility design and validation
GMP input to facility design, and qualification and validation support for new and modified facilities, utilities and equipment.
Design decisions made early determine how easy a facility is to operate compliantly for decades. We review layouts, flows, classification and utility concepts against GMP requirements for the intended dosage forms, then support commissioning, qualification and process validation through to routine operation.
Scope
- GMP review of user requirements, layouts and material and personnel flows
- Validation master planning
- Qualification protocols and execution support (DQ, IQ, OQ, PQ)
- Cleaning validation and process validation
- Technology transfer and new-site start-up support
How we approach it
Dosage-form specific
Requirements differ between oral solids, sterile products and other forms; our advice reflects that.
Lifecycle approach
Validation is planned as a lifecycle, not a one-off event.
Inspection-ready records
Protocols and reports are written to withstand regulatory review.
Related services
Consulting
Regulatory inspection preparedness
Mock inspections, gap analysis and coaching so your site and your people are ready for USFDA, MHRA, MFDS, EDQM and other regulatory inspections.
Learn moreConsulting
Process review and improvement
Structured review of production, laboratory and quality processes to remove bottlenecks and reduce compliance risk.
Learn moreConsulting
Operational excellence
Lean principles, performance measurement and process optimisation applied within a GMP environment.
Learn more