Validation & Qualification Process Validation Services

Demonstrate your manufacturing processes consistently produce quality products through comprehensive validation that satisfies regulatory requirements while optimizing operational efficiency.

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Prove that your processes deliver quality every time

Process validation has evolved from end-product testing to lifecycle management. The FDA's current guidance demands continuous verification that your processes remain in control, from initial design through commercial production and beyond. This shift requires sophisticated approaches that balance scientific rigor with business practicality.

Yet many organizations struggle with validation complexity. Over-validation wastes resources and delays products. Under-validation risks regulatory action and quality failures. Legacy approaches don't align with current expectations. The key is risk-based strategies that focus effort where it matters most.

Our process validation experts bring a deep understanding of both regulatory expectations and manufacturing realities. We've validated processes across every production scale and technology, always focusing on demonstrating control while enabling efficiency.



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Our process validation services include:

  • Validation master planning and strategy

  • Stage 1: Process design documentation

  • Risk assessment and critical parameter identification

  • Stage 2: Process Performance Qualification (PPQ)

    • Protocol development for process performance qualification

    • Execution of PPQ runs under normal and worst-case conditions

    • Statistical evaluation of process data to confirm consistency and control

  • Stage 3: Continued process verification

    • Statistical process control (SPC) implementation

    • Annual product review integration

  • Legacy process remediation

  • Validation lifecycle management

  • Change control impact assessment

  • Revalidation strategies

Process types we validate include but are not limited to:

  • Drug substance manufacturing
  • Drug product manufacturing
  • Biotechnology processes
  • Medical device assembly
  • Combination product manufacturing
  • Packaging operations
  • Cleaning processes
  • Sterilization processes
  • Aseptic processing

Click to expand Our approach to process validation

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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

    • Validation Master Plan (VMP) development with risk-based scope and lifecycle focus
    • Process design documentation and mapping of inputs, outputs, and failure modes
    • Risk assessment and CPP/CQA identification using tools like FMEA and DoE
    • Protocol planning for PPQ and CPV
    • Change control and revalidation planning

     

  • Qualification & Execution

    • Process Performance Qualification (PPQ) protocol development and execution
    • Statistical analysis to confirm acceptable variation and process reproducibility
    • Deviation handling with root cause analysis and CAPA integration
    • Collaboration with equipment qualification teams to ensure supporting systems (IQ/OQ/PQ) are in place and verified before PPQ execution 

  • Continued Process Verification (CPV)

    • Real-time monitoring and statistical control charts
    • Revalidation triggers tied to process or equipment changes
    • Annual Product Review (APR) integration for ongoing compliance
    • Legacy process remediation to meet current expectations 

  • Process Types & Technologies We Support

    • Drug substance and drug product manufacturing

    • Biological / biotech processes

    • Medical device assembly and combination manufacturing

    • Packaging, sterilization, and cleaning processes

    • Aseptic processing

    • Utility systems and support equipment

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Why teams work with us for validation projects

  • Lifecycle expertise: We understand all three validation stages
  • Risk-based approach: We focus resources where they matter
  • Statistical rigor: We demonstrate control with confidence
  • Operational insight: We validate without constraining production
  • Regulatory alignment: We make sure you meet current FDA expectations

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Why work with The FDA Group?

 
  • Exclusive life science focus and expertise
  • Dedicated account management team
  • Right resource, first time (95% success)
  • 97% client satisfaction
  • Total Quality Guarantee

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Our Proven Process

Introductory Conversation

  • About Us
  • About You
  • Scope Of Work

Resources Definition

  • Background And Expertise
  • Location Of Resource
  • Rate Rightsizing

Proprietary Resource Selection Process

  • In-House Subject Matter Experts
  • Recruiting Team External Search
  • Resource Identification

Resource Presentation

  • CV And Rate
  • Perfect Match Summary
  • Interview Call Coordination

Agreement Processing

  • MSA And Addendums
  • Supplier Qualification
  • Kickoff Coordination

Account Management

  • Project Management Of Resource
  • Satisfaction Management of Client
  • Total Quality Guarantee

Contact us and get the conversation started.

Our resources can be utilized to meet the wide range of remediation requirements throughout the life sciences, as well as to support staffing assignments, lead and manage related activities, bridge staffing gaps, and provide long-term or interim leadership.

Please contact us to learn more about fulfilling specific validation needs. We help clients secure a wide variety of life science resources for both contracted and direct hire engagements with the perfect combination of qualifications, experience, and motivation for succeeding in challenging and demanding projects.