Consulting
Project management
Planning and coordination for GMP-related projects, from quality-system upgrades to remediation programmes.
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Process review and improvement
Structured review of production, laboratory and quality processes to remove bottlenecks and reduce compliance risk.
Processes drift. Steps are added after deviations, workarounds become habit, and cycle times grow. We map how a process really runs, compare it to the written procedure and the regulatory requirement, and redesign it so that it is both compliant and efficient.
Typical targets
- Deviation and CAPA handling
- Batch record review and release
- Change control
- Laboratory investigations (OOS/OOT)
- Document control and training
How we approach it
As-is before to-be
We map the process as it is performed before designing improvements.
Compliance kept in view
Efficiency gains never come at the cost of regulatory expectations.
Measured
Baseline and post-change metrics show whether the change worked.
Related services
Consulting
Facility design and validation
GMP input to facility design, and qualification and validation support for new and modified facilities, utilities and equipment.
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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.
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Operational excellence
Lean principles, performance measurement and process optimisation applied within a GMP environment.
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