Elevating quality management at Torbay Pharmacy Manufacturing Unit

Introduction

Torbay Pharmaceuticals, a dedicated pharmacy manufacturing unit within South Devon NHS Foundation Trust, produces a wide range of sterile products and meets stringent standards, including MHRA, EU GMP, ISO 9001:2008 and ISO 13485:2003. Faced with the challenges of managing quality processes across three locations, the unit sought an electronic solution to replace their time-consuming, paper-based systems.

The challenge

Before Ideagen, Torbay Pharmaceuticals faced several critical challenges:

• The unit needed a centralized system to eliminate disjointed processes and unify quality management across three different locations.
• With time-consuming paper-based systems, managing compliance with MHRA, EU GMP, and ISO standards was labor-intensive and prone to errors.
• The existing system made it difficult to maintain visibility and control of compliance activities and encourage ownership within the quality management system.

Finding the right solution

Torbay Pharmaceuticals selected Ideagen as their quality management solution due to its ability to:

• Centralize the management of quality processes across multiple sites.
• Replace paper-based systems with an electronic solution that enhances efficiency and reduces duplication of effort.
• Provide real-time oversight of compliance activities, improving the overall management of quality.

Implementation and impact

Ideagen Quality Management not only addressed Torbay Pharmaceuticals’ immediate challenges, but also provided a scalable platform for future growth. The transition to electronic processes enhanced compliance, reduced paperwork, and ensured consistent operations across all sites.

Overall, the implementation resulted in:

• Centralized documentation, improving the efficiency of storing and reviewing procedures, forms, and agreements.
• Automated notifications for calibration and servicing, ensuring all equipment remained compliant.
• Improved CAPA management, with continuous visibility of corrective actions until completion.
• Streamlined audit processes, with easy access to results and analyses from a single source.