Process Validation

Process Validation

Process validation for consistent quality and performance across manufacturing operations.

Overview

Our process validation services ensure that your manufacturing processes consistently produce products meeting predetermined quality attributes and specifications throughout the product lifecycle.

Service Scope

  • Process Design (Stage 1)
  • Process Qualification (Stage 2)
  • Continued Process Verification (Stage 3)
  • Cleaning Validation
  • Method Validation
  • Hold Time Studies
  • Packaging Validation

Regulatory Standards

FDA Process Validation GuidanceEU GMP Annex 15ICH Q8/Q9/Q10WHO TRS 937PIC/S PI 006

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