Today’s pharmaceutical and biotech industries are growing at an increasing rate across the globe. With demand for manufacturing production on the rise, commissioning, qualification and validation services are important factors to ensure facilities, utilities and equipment perform as intended. When performed well, validation services helps clients:
- Reduce time and money addressing qualification deviations
- Ensure a smooth transition from design to construction to operation
- Meet current regulatory guidance and expectations
- Create robust, reliable and repeatable manufacturing processes
GBA’s validation team includes knowledgeable consultants, who bring expertise and perspective as owners, owner’s representatives, consultants and contractors. This means that they understand the challenges of balancing time, effort and money, while following full GMP compliance. Team members will work with clients to ensure that all internal and external operations, engineering, regulatory and QA standards are met.
With this owner’s perspective, GBA’s team is able to work towards your product’s global success. This global view of projects incorporates project timelines, costs, contracts, commitments, and the importance of working hand-in-hand with all project team members. This ensures overall project success prior to manufacturing.
GBA utilizes a risk-based approach to qualification that aligns current regulatory requirements with your unique business constraints. We never follow a copy and paste or one-size fits-all approach. Instead, we customize each validation package to match the process at hand. GBA provides the following services:
- Equipment, facility and utility commissioning and qualification
- Process validation
- Cleaning validation
- Computer system validation
- AIQ, Method validation
- Validation program and master plan development
- Gap analysis/risk assessments
- Quality system development and remediation