IRBM S.p.A.

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QUALITY ASSURANCE

Manufactured lot of vaccine vials with blue and white labels are ready for shipping after release by quality assurance

QUALITY ASSURANCE

Quality assurance for cGMP regulatory compliance

Advaxia specializes in developing protocols and practices for fully compliant QA.

Advaxia Quality Policy has been structured to comply with the standards required by National and International Agencies.

The Quality Management System (QMS) is the set of interrelated or interacting quality systems used to direct and control how quality policies and its standards are implemented and how the objectives are achieved to ensure compliance with regulatory requirements and that the requirements of the company Quality Policy are met.

The establishment and maintenance of a satisfactory quality system assure the correct manufacture and control of pharmaceutical products for clinical studies, to carry out all necessary tasks and to assure the implementation and the respect of QMS regulatory and internal policy requirements.

At Advaxia, industry-leading quality assurance (QA) is in our DNA. Our team has developed detailed protocols and practices to improve and streamline the QA process for all our project workflows, and we rigorously examine every production run to maintain transparency and compliance with the regulatory guidelines set forth by major agencies, including the guidance provided by EMA, AIFA, FDA, and other local governmental entities.

We are proud to make this level of QA available to our clients — indeed, we often work directly with clients’ in-house teams to develop monitoring programs tailored for their unique workflows.
Throughout every project, our goal is not only to ensure that stringent quality standards are applied to all production runs, but also to identify areas for further improvement at various stages of the process.

Our dedicated QA team is ready to review and optimize all aspects associated with the quality of your project, providing you with a robust data package that ensures your peace of mind.

The primary objective is to work effectively and efficiently in partnership with our customers to produce safe and efficacious vaccines.

We meet the highest levels of compliance with European and FDA regulations and guidelines for the manufacture of vaccines for clinical use. We are continually improving our quality system with regulatory intelligence and routine internal audits.

We provide this quality assurance as standard and strive to give you more. We also share our expert knowledge of regulatory processes and offer support for your applications.

Three vials of vaccines secured in machine after quality control checks

Advaxia offers a full suite of QA capabilities, including: