AMLS Completes Unique CQV Project for Global Biotechnology Company
AM Life Science (AMLS) recently completed a Commissioning, Qualification, and Validation (CQV) project for a global biotechnology company.
The project called for AMLS to lead a CQV team to implement disposable technology for buffer filtration and hold processes at the biotech company’s 14,000-sq. ft. pharmaceutical facility.
Fortunately, AMLS already had a working relationship with the company, which made it easy to transition from one project to the next since we already had experienced personnel on the ground.
Why are CQV Projects Critical for Pharmaceuticals?
The process of Commissioning, Qualification, and Validation includes testing equipment, verifying proper installation, and ensuring that the facility is compliant with industry regulations.
Specific to the pharmaceutical industry, the CQV process is critical to meet the requirements of the stringent industry standards set by the FDA.
As an owner-centric CQV partner, AM Life Science is experienced in change management and can help facilities address any issues with the FDA because we have intimate knowledge of what is required by regulatory bodies.
What Unique Services Did AMLS Provide in the CQV Project?
For this CQV project, AMLS was asked to address special circumstances at the biotech company’s facility. AMLS provided these unique services to satisfy the request:
- Compliance with a revised equipment lifecycle approach
- Identified gaps resulting from the modified approach
- Mitigated gap conditions where required
“We believe we have the best approach to CQV projects in the industry,” says Rod Azadan, Head of AM Life Science. “Our team thoroughly evaluates our client’s needs and assesses the best approach before starting a project. Combining our pre-project planning and analysis with previous CQV services we provided to the client, we were able to complete their latest project within the timeline, budget, and safety requirements.”
AM Life Science understands CQV execution and focuses on forward planning to reduce roadblocks at later stages of each project. To find out more about our services and how to achieve complete quality assurance, contact our team today!