GMP Auditing Services
Assuring Compliance While Building Quality Into Your Products
Ensuring your processes and controls are robust enough to prevent even minor variations in your process, and ultimately in your final product quality, is no easy task. However, an inability to do just that means you are falling short of FDA expectations. The only way to ensure processes are, in fact, in control is to perform an audit of the facility and review processes, procedures, systems, facilities, and more. These audits not only ensure compliance with regulatory expectations but most importantly help build quality into the products which are consumed by patients.
ProPharma Group provides Good Manufacturing Practice (GMP) auditing for FDA regulated industries that manufacture, test, store, and distribute therapeutic and diagnostic products used in human and veterinary health. With a diverse range of technical and regulatory compliance experience, we can address the wide variety of clients and suppliers in the following industries:
- Medical device
- Compounding pharmacy
- Dietary supplement
This allows us to put the appropriate resources on each audit at the right time. Our hands-on approach to GMP audits is our way of collaborating with you to develop risk-based remediation plans, enhancing the level of quality and building on your programs already in place.