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Reduce Cost of Poor QualityRestore Execution Stability

GMPKit is a specialist consultancy focused on reducing Cost of Poor Quality (COPQ) in pharmaceutical manufacturing. We lead implementation with site leadership to correct structural execution friction—so batch flow becomes predictable, deviations stop compounding, and performance holds.

Implementation-ledOutcome-ownedBuilt for GMP

Where Cost of Poor Quality Comes From

COPQ is the financial impact of structural execution friction — including lost batches, deviation backlog, delayed disposition, rework, and underutilized capacity.

Lost batchesFailed or rejected product that never reaches disposition
Deviation backlogUninvestigated deviations delaying batch release
Delayed dispositionExtended cycle times consuming capacity and cash
ReworkRepeated operations that signal process instability
Underutilized capacityThroughput constrained by governance failures
Employee attritionLoss of experienced operators driven by sustained execution instability

How GMPKit Delivers Results

01

Structural COPQ Diagnosis

We identify where execution friction is generating the largest financial losses — using diagnostic frameworks, COPQ quantification, and constraint analysis.

02

Implementation Ownership

We lead implementation with site leadership through our 6-Stage Operating Model. We do not advise and exit — we implement structural correction and measure results.

03

Governance Discipline That Sustains Results

Operational stability is not a project outcome — it is a governance discipline. We build the systems that prevent regression after the engagement ends.

Every GMPKit engagement runs through a structured 6-Stage Operating Model — the mechanism that takes a site from COPQ diagnosis through implementation and into sustained governance.

Explore the Operating Model

Proven Results Across Pharmaceutical Manufacturing

We've delivered measurable results across CDMOs, biopharma sites, and advanced therapy manufacturers— restoring operational stability when it matters most.

60-80%

Backlog reduction in 90 days

20-40%

Batch success rate improvement

30-60 Days

Inspection readiness achieved

120 Days

Successful scale-up completion

Ready to Reduce COPQ?

Start with a diagnostic call to identify where COPQ is generated — or use the COPQ Calculator to quantify the financial impact first.