Our GQMS stems from the Global Quality Policy and includes Global Standards, Global Guidance, Global Operating Procedures and other corresponding documentation. The GQMS allows for local quality systems to meet local regulatory requirements while also meeting minimum Bausch Health Quality requirements.
As part of our risk assessment process, we use a systematic approach which provides proactive means to identify, assess, remediate, mitigate, escalate, monitor, review and communicate potential quality risks applicable to products and services, processes, systems and projects. Our full Product Lifecycle Product Realization encompasses the systems that guide the Development and Manufacturing organizations throughout the product lifecycle from the early stages of product development to full-scale manufacturing and product retirement.
Bausch Health operates an independent Quality function lead by the Chief Quality Officer, who reports directly to the Chief Executive Officer. Our Executive Leadership has the ultimate responsibility to ensure an effective pharmaceutical quality system is in place, that roles, responsibilities, and authorities are defined, communicated, and implemented throughout the company, and that adequate qualified resources are available to implement the GQMS. The Quality Leadership Team reporting to the Chief Quality Officer has day-to-day responsibility of our quality programs
We strive to foster a culture of quality. As such, we ensure personnel involved in relevant processes are trained and/or qualified for their assigned task. We provide quality training to new employees during the onboarding process and offer ongoing annual quality and safety training.
Management identifies the requirements for personnel that require training and ensures that they are given proper knowledge, training, strategic direction, documentation and the required equipment and other assets to execute their role in accordance with business and regulatory requirements.
Bausch Health has a strong auditing program covering both our own operations and those of our suppliers. We are committed to ensure that product, intermediates, components, and raw materials are sampled and tested in accordance with established procedures. Thorough investigations are conducted when any deviations from current GMPs or other relevant regulations occur, or when out-of-specification results or any other failures in manufacturing processes are detected. Incidents are assessed by subject matter experts and conclusions are provided to the appropriate health authorities with relevant documentation. Actions, such as recalls, are executed in agreement with the relevant authorities.
We hold relevant manufacturing licenses and applicable Good Manufacturing Practice (GMP) certificates for our manufacturing, supply and distribution operations. We are subject to external health authority inspections, including:
- U.S. Food and Drug Administration (FDA)
- Health Canada (HC)
- Medicines and Healthcare products Regulatory Agency (MHRA)
- European Medicines Agency (EMA)
Additionally, Bausch Health is routinely inspected by multiple Notified Bodies. As such, Bausch Health also holds relevant ISO and MDSAP certifications for the manufacture and distribution of medical devices.
As part of our GQMS, we identify, document, and evaluate product-related complaints and take action as required. We ensure that any required adverse event reports, aggregate safety reports, ad hoc urgent safety restrictions following an acute change in benefit-risk ratio, other changes in product risk-benefit ratio, and validated safety signals are submitted to the appropriate regulatory agencies within required time frames and are otherwise communicated to relevant stakeholders, such as healthcare professionals and the public.
We have formalized Corrective & Preventive Action (CAPA) Management programs throughout our Operations and regularly test the adequacy of our emergency response procedures. If non-conformance events occur, they are identified, documented, evaluated and appropriate actions are taken to identify, segregate and disposition nonconforming products, components, or materials according to written procedures. We have formalized procedures to ensure a timely and effective communication and escalation of non-conformance issues to the appropriate level of management.
Management ensures governance and continuous improvements to the Quality Management System through regular review of the quality system and monitoring of regulatory requirements and ensure these modifications are understood by personnel and remain effective.