November has long been designated as “Global Quality Month.” This annual event serves to recognize the Global Quality Community and acknowledge the worldwide application of Quality Principles in everything we do. The American Society for Quality calls this month “… a time to celebrate — a time to showcase the advancements and valuable Quality contributions in businesses, communities, and institutions.” As a pharmaceutical CMO, Quality is of significant importance for Avara Pharmaceutical Services and one of our values and key capabilities.
The theme of Avara’s Quality Month 2020 is, “Creating Customer Value.” Avara creates value to our clients by sustaining a modern and robust Quality Management System that ensures the supply of high-quality medicines to patients who need them. Flor D. Rivera, Avara’s Vice President of Quality Assurance & Regulatory Affairs, stated: “With the aim of creating value to our customers, Avara established Quality Principals, to which all of our personnel are committed. We also established the Driving Elements, the foundation and cornerstone of our Quality Culture: Data Driven Thinking, Risk Management - Risk Based Decisions, and Continuous Improvement. Based on these elements and using the Quality system approach, we embarked on the implementation of our Avara Quality Management System. One sole, modern system, standardized across our Sites, current with applicable regulations and best industry practices. Our QMS and Quality Culture are an important aspect of the value we provide to our clients.”
Since Avara fully understands the role we play and the impact we have in global public health, Avara Senior Leadership ensures adherence with the established QMS throughout our network. By focusing on product safety, setting and meeting goals, and monitoring industry trends and best practices, Avara’s Quality Unit ensures compliance with applicable cGMP regulations, compliance with our clients’ regulatory applications, and to the manufacturing activities and industry standards related to the products we manufacture for our clients.
Led by the Quality Leadership Team, Avara’s Quality Units work every day to ensure our Quality Systems are seamlessly integrated within our overall business framework and serve to complement our mission of providing responsive, agile, flexible, modern, and tailored contract manufacturing services to pharmaceutical innovators and drug developers of all sizes. This has been accomplished while maintaining a state of compliance and ensuring business continuity and ongoing supply. This is evidenced by the satisfactory closure of all regulatory inspections and client audits, thereby granting the applicable approvals, certifications, and compliance status. By partnering with our clients and collaborating with government and regulatory agencies, Avara is proud to support the introduction of new products and increase the availability of therapies related to the current Covid-19 pandemic.
We hope you will join us in celebrating Quality Month 2020!