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. Azzur Group specializes in commissioning and qualification, process validation, and cleaning validation.

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
Process 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

Cleaning Validation

Our industry experts are uniquely qualified to help develop and validate your cleaning processes. We have the experience and techniques to transfer the initial lab cleaning studies to the manufacturing equipment where the cleaning process is optimized saving labor costs, production time, and utilities. We fully understand all aspects of cleaning validation and the challenges it presents including conducting lab coupon studies, validating analytical methods, calculating carryover acceptance criteria, sampling using swab and rinse techniques, performing visual inspections, and setting up periodic monitoring programs.

We routinely assist clients with setting up programs, investigating cleaning issues and deviations, optimizing cleaning processes, and providing various trainings to better understand a misunderstood discipline. Get in touch with us.