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Qualification and Validation

A Lifecycle Approach to Compliance

When it comes to quality, compliance, and safety, maintaining a validated state is imperative for any GxP organization. Beginning with a clear vision in mind, Azzur Group takes a lifecycle approach to validation that enables you to start, scale, and sustain your operation.

 

Our bottom line is ensuring that you have the people, processes, and procedures to meet the standards set forth by leading regulatory bodies.

From installation and start-up commissioning to verification and qualification, our validation SMEs set you up for success so you're able to sustain effectiveness, efficiency, and high quality —no matter where you are in the life science lifecycle. 

Our qualified cGMP consultants are immersed in the standards and guidance set forth by the FDA, EMA, and other regulatory bodies including: 

  • 21 CFR Parts 11 and 820

  • FDA 2011 Process Validation Guideline

  • Eudralex Volume 4 (EU cGMP Guideline)

Commissioning and Qualification

Azzur Group's engineering experts are committed to helping clients start-up or renovate their facility, utilities, systems, and equipment (FUSE) through our risk-based commissioning and qualification.  

Installation & Start-Up Commissioning 

  • Design Reviews 
  • Factory Acceptance Tests 
  • Receipt and Inspection 
  • Site Acceptance Testing 
  • Commissioning Protocol/Checklists 
  • Punchlist Management

Verification/Qualification & Validation 

  • User Requirement Specifications 
  • Function Requirement Specifications 
  • Detailed Design Specifications 
  • Critical Aspect Risk Assessments 
  • Facility Validation Master Plans 
  • Installation Verification/Qualification 
  • Operational Verification/Qualification 
  • Cleaning/Steaming Cycle Development 
  • Performance Verification/Qualification 
  • User Requirement Specifications

Process Validation

Together, we work with you to take a lifecycle management approach to process validation. 

Process Design
Develop a sustainable process with product quality as the focus 
  • Together, we will review current practices and design a manufacturing process rooted in scientific evidence 
  • Validation Master Plan
Process Qualification
Verify your process design at manufacturing scales 
  • Design by evidence, we will lead you through qualification of the facility, equipment, systems and utilities to ensure they are suitable for the intended use 
  • Proceess Performance Qualification
Process Verification
Ensure process consistency 
  • Backed by comprehensice preparation, we will set the course to ensure that your processes remain in a state of control following successful PPQ 
  • This continuous monitoring allows for adjustments to inputs and compensates for process variability to ensure output is consistent 
How Can We Help?
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