Headquartered in Sofia, Bulgaria, Huvepharma focuses on bringing human health and animal health and nutrition products to market. The company has gained a track record as a fast-growing global pharmaceutical company in the past ten years.
With independent manufacturing units in Bulgaria, Italy, France, and the US — and over 90 affiliates and offices worldwide — Huvepharma’s ambitious growth demanded a strong focus on quality and implementing a global quality management system. Huvepharma’s quality team realized it needed compliance management software to ensure the delivery of safe, quality products to its customers.
“Reliance was selected because it was flexible, highly configurable, easy to modifiy in house — and it was FDA and EU compliant, giving audit trail electronic signatures traceability. It had very good connectivity between modules, records and processes. Also, its intuitive interface looks similar across modules — very important for a multi-site company such as ours,” Mina Gavrilova, Quality Manager, Huvepharma
Meeting the need
When they decided to implement a QMS in pharmaceuticals, Huvepharma faced unique compliance and quality process challenges. Standardizing quality processes across many global sites was difficult as each location had to meet its own specific governmental and industry regulations. Developing and implementing standardized quality processes across many global sites was difficult, as processes needed to meet each location’s specific governmental and industry regulations. In addition, Huvepharma’s “paper quality culture” made staff reluctant to move away from tried-and-true manual processes to a compliance management system, and multiple languages complicated quality processes and made training across all production sites a tedious task.
The company was experiencing rapid growth, and its quality team understood that to provide the accurate analytics that would empower data-driven decisions, it must standardize its quality processes and documentation across the entire product lifecycle. The team also wanted to reduce nonconformance, improve supplier quality, work with suppliers on corrective actions, and reduce corrective action closure time.conformance, improve supplier quality, work
Filling the gap
Today, Huvepharma counts on Octave Reliance (formerly ETQ Reliance) to comply with regulations across the globe, including regulations set forth by the European Union Good Manufacturing Practices (EU GMP), the United States Department of Agriculture (USDA), and the United States Food and Drug Administration (US FDA).
The company kicked off the use of Reliance by implementing change management, events, and CAPA applications across its sites in Bulgaria, Italy, and the US. Then, Huvepharma went live with document control and complaints management before implementing events, CAPA and change control for its French sites. Most recently, Huvepharma has migrated paper documents — including SOPs, policies, guidelines, templates, protocols, and reports — from their sites in Bulgaria, Italy, the US, and Belgium into Reliance.
Working with Reliance has provided Huvepharma with harmonization across all its entities, ensuring compliance for every international site. Able to use Reliance right out of the box with minimal customization, Huvepharma’s quality team enjoys global oversight of quality compliance and process improvements, allowing them to maximize efficient use of the team’s resources.
Looking forward
With early wins in document control, complaints management, change control and CAPA, Huvepharma plans to continue using Reliance to standardize and streamline the company’s quality management processes. The quality team has plans to implement training management and supplier qualification applications.
About Huvepharma
Huvepharma is a fast-growing global pharma company (in terms of sales growth), focusing on developing, manufacturing, and marketing animal and human health and nutraceutical products. Its key strengths lie in large-scale fermentation and technical expertise developed over half a century at its European manufacturing sites. With the joint venture partnership, Huve Nutraceuticals brings expertise in microorganisms to produce ultra-high quality, very competitive algal-based ingredients and finished products for human, pet, and aquaculture nutrition applications. For more information, visit www.huvepharma.com.
