Maximizing the Benefits of Life Cycle Process Validation - Integrated Project Services - IPS
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IPS

Maximizing the Benefits of Life Cycle Process Validation

Process Validation has shifted from “three runs and done” to a risk-based life cycle approach focused on critical quality attributes (CQAs) and critical process parameters (CPPs). Our experts apply our unique methodologies to help you easily implement the new FDA process guidelines for both new and existing facilities.

With over 22 years of hands-on experience, IPS offers a comprehensive approach to understanding the regulations and validating the process to ensure the consistency and quality of the manufactured product.

From applying proven process mapping techniques to identifying interrelationships between a product’s CQAs and its CPPs, IPS can help companies in controlling variations and reducing costs. Our knowledge, skill and passion help our clients achieve their business and compliance goals.

Process Validation Services

  • Perform Value-Added Gap Analyses/Risk Assessments/Audits
  • Flowchart Processes for Baseline Understanding
  • Draft Regulatory Compliant Validation Master Plans and Project Plans
  • Create Robust Validation Programs
  • Identify & Justify Product CQAs
  • Understand CPPs & Mitigate their Impact on CQAs via Control Strategies
  • Execute Design Qualifications of Equipment and Utilities Capturing User Requirements
  • Factory Testing & Commission of Equipment and Utilities
  • Develop User-Friendly SOPs
  • Execute Process Performance Qualifications Encompassing Critical Elements
  • Complete Meaningful Statistical Data Analysis
  • Implement Ongoing Process Verifications to Comply with Stage 3 FDA Guidelines
  • Troubleshoot & Investigate Process Issues
  • Perform Focused Trainings & Presentations