The purpose of Quality Assurance is to ensure that products, processes, and services comply with applicable quality standards and regulations and to help detect and/or prevent mistakes or defects in the product development and production process. Continuous improvement is key to minimizing risks and errors, meeting client demand and keeping quality management systems up to date.

There are different methods to improve the quality of products, processes, and services, resulting in a reduction of time, cost, and effort. To guarantee quality, all actions and associated documentation must also meet the legal requirements. Therefore, a thorough understanding and knowledge of current and applicable guidelines from the relevant authorities are crucial to ensure high product and process quality and regulatory compliance.

Quality Assurance personnel must meet elevated expectations. It can be a challenge to stay abreast of developments, as guidelines and expectations from regulators are constantly changing. Guidelines also describe general requirements, but implementation can be difficult in practice. And every quality system requires continuous maintenance and improvement by the Quality Assurance department. There are various guidelines, such as the ICH Quality Guidelines.

Progress can support your Quality Assurance department in several ways. We employ experienced consultants who can (help) set up and implement a GxP, ISO-based Quality Management System or phase-appropriate quality system for the development, production, testing and/or distribution of medicinal products and APIs. We also provide Interim Management services and expertise in all quality systems, be it Change Control, Deviation Management, Documentation Management, Product Quality Review, Management Review or Quality Risk Management.

We believe that Quality Assurance is not about creating more documentation or hiring more people, but about awareness, ownership, and efficiency, throughout the organization. With our knowledge and experience, we can collaborate with you to ensure continued quality compliance of your product and processes throughout the entire life cycle, while maintaining the focus on your core processes.