We treat process validation as a lifecycle and tailor our support across three overlapping domains: Strategy & Planning, Qualification Execution, and Post-Validation Control. Wherever your process stands, we can plug in.
Strategy & Planning
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Validation Master Plan (VMP) development: Define scope, roles/responsibilities, risk-based prioritization, resource forecast, revalidation criteria, and lifecycle approach.
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Process design documentation & mapping: Translate how the process should work into critical steps, inputs/outputs, acceptance criteria, and failure modes.
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Risk assessment & critical parameter identification: Use tools like FMEA or DoE to pick critical process parameters (CPPs) and critical quality attributes (CQAs) that merit control and monitoring.
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Protocol planning: Draft high-level plans for Process Qualification (PQ), Performance Qualification (PQ), and Continued Process Verification (CPV).
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Change & revalidation planning: Plan how you will handle change control, regression, and triggers for revalidation.
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Qualification & Execution: Proving Control
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Installation Qualification (IQ) & Operational Qualification (OQ): Ensure equipment, utilities, and systems are installed and operate per design specs.
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Performance Qualification (PQ): Demonstrate that the process reliably produces a product meeting all quality attributes across normal operating ranges.
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Process qualification (PPQ): Run batches under normal (and worst-case) conditions, collect data, and verify consistency.
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Statistical analysis & acceptance justification: Use statistical tools to evaluate performance (e.g., capability indices, control charts) and validate that process variation is acceptable.
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Deviation and out-of-spec handling: Define procedures for addressing deviations, root cause investigation, corrective actions, and data reconciliation.
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Continued Process Verification & Lifecycle Control
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Real-time monitoring & control charts: Implement SPC or other statistical monitoring to detect drift before it becomes a failure.
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Revalidation & change control response: Define triggers (e.g. process changes, equipment changes, trending) that require requalification.
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Annual Product Review (APR) integration: Feed data from CPV into APRs to drive continuous improvement and demonstrate ongoing control.
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Remediation & legacy process modernization: Fix or bring into state-of-control older validated processes that may not meet current expectations.
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Process Types & Technologies We Support
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Drug substance and drug product manufacturing
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Biological / biotech processes
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Medical device assembly and combination manufacturing
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Packaging, sterilization, and cleaning processes
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Aseptic processing
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Utility systems and support equipment
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