Commitment to Quality

A robust culture of integrity and accountability is in place in which quality and compliance are seamlessly integrated into day-to-day business processes and activities to help ensure the highest priority is placed on the safety of our patients, quality of our products, integrity of our data, and Pfizer’s reputation.

Senior leaders with the appropriate accountability and decision-making authority periodically review the performance of the QMS to ensure that it continues to fulfill quality objectives, remains aligned with the strategic direction of the organization, is supported by appropriate resources, and provides a pathway for escalation of quality, safety and compliance issues and risks.

Known and emerging quality, safety and compliance risks are identified, assessed, escalated, and mitigated.

Processes, policies and procedures and any associated changes are managed in a controlled manner, commensurate with the level of risk.

All individuals who perform work for, or on behalf of, Pfizer have the appropriate education, training, skills, qualifications, and experience to carry out their work competently, in accordance with all applicable laws, regulations, and Pfizer policies and procedures.

Programs and plans are in place for monitoring process performance, product quality, safety and compliance with applicable regulations and Pfizer policies to ensure a state of control is maintained.

Quality issues are investigated, with effective corrective and preventative actions (CAPA) implemented. Mechanisms are in place for timely escalation of critical quality, safety, and compliance issues.

Controls are in place to manage risks that originate from, or are related to, dependence on external entities, including third parties conducting work on Pfizer's behalf and other partnership arrangements, designed to ensure compliance with all applicable regulations and Pfizer policies.