Process Validation

Process Validation

Process Validation
Guided by strict principles at every stage of the validation game
 
Imperative to your cGMP organization are processes rooted in quality, consistency, and reproducibility. 
 
Simply stated: You MUST ensure that the processes you design are fit for intended use. 
 
Even the smallest process oversight can lead to product failures, rework, and regulatory concerns. Establishing scientific evidence around quality processes ensures the consistent delivery of your life-changing products.
 
At Azzur Group, we are guided by the principle that quality should be built into a process rather than determined by final-product testing. Therefore, we work hand-in-hand with leaders in the pharmaceutical, biotech, and medical device industries to foster and maintain qualified and validated processes at every stage of the product development and commercialization lifecycle. 
 
Understanding that the process validation lifecycle is never complete, but dynamic and ongoing, our team of engineers and consultants integrate seamlessly with clients to guide process design, process qualification, demonstration of safety, and continued verification for routine production processes. 
 
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)
 

What sets us apart

No one person is an expert in all industries. That is why we have invested in a robust team of engineers, scientists, and consultants--each with distinct areas of expertise--who serve as active resources for our clients. 
 
With Azzur, our team becomes a part of your team. With your best interest at the forefront, we’ve developed a risk-managed, comprehensive, and scalable model for project-based process validation that allows you to focus on bringing quality products to market. At any given time, you can rest assured that you’re working with the right team on the right deliverables at the right time. 


Our services 

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
    • Driven by evidence, we will lead you through qualification of the facility, equipment, systems and utilities to ensure they are suitable for the intended use
    • Process Performance Qualification
  • Process Verification - Ensure process consistency 
    • Backed by comprehensive 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
 
Finally, our team not only delivers real results, but we ensure your validated state for years to come. 
 
Our full-scale, customizable training services encompass in-person kinesthetic training, as well as online modules, that can be used to bring your entire workforce up to speed and guarantee a validated state for your cGMP organization from installation through operation and performance.
 
 
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