Pfizer’s Quality & Safety: At a Glance
Pfizer puts patient health and safety first: our Quality Management System (QMS) enforces standards across development, manufacturing, and distribution to ensure every dose is safe and effective.
What is Pfizer’s Quality Policy?
Quality at Pfizer isn't a checkpoint; it’s embedded in how we think, how we operate, and how we deliver for patients. It reflects the care, integrity, and accountability our colleagues bring at every step - from the lab to the patient
Our Corporate Quality Policy describes how Pfizer ensures the delivery of safe and effective drugs, biologic, consumer, medical device, and combination products, and meet regulatory requirements and other relevant standards and guidelines. It provides a systematic approach designed to ensure Pfizer meets our commitment to patients, and it defines the elements of our Quality Management System (QMS) for regulated activities.
Our commitment to developing, manufacturing, and delivering quality products to patients is built on four key pillars:
- Maintaining an effective QMS within and across divisions
- Complying with all applicable quality regulations, codes, and standards
- Maintaining an integrity-focused culture where each person is required to carry out their responsibilities with proper regard for quality, ensuring the highest priority is placed on the safety and efficacy of our products, the integrity of our data, and the trustworthiness of interactions with our stakeholders
- Reporting and addressing quality issues, risks, and concerns through appropriate corporate or divisional processes
How Does Pfizer Ensure Product Quality?
Patient health and safety are foundational to everything Pfizer does. We set high standards for our product quality and safety because behind each dose is a person — a parent, healthcare worker, friend, or child — who depends on us. Pfizer’s global vision is rooted in sustainability and collaboration, working with responsible, ethical, and reliable partners to create a resilient manufacturing network that meets rigorous quality standards.
Quality is a shared responsibility across Pfizer. In this video, hear from scientists, manufacturing leaders, and operations specialists about how patient safety, data integrity, and personal accountability shape their work.
What Are the Core Elements of Pfizer’s Quality Management System?
- How Pfizer builds a culture of quality and integrity?
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, and integrity of our data.
- How Pfizer governs its Quality Management System?
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 matters, ensuring compliance with applicable laws, regulations, and Pfizer policies and procedures.
- How Pfizer identifies and manages quality risks?
Known and emerging quality, safety, and compliance risks are identified, assessed, escalated, and mitigated.
- How Pfizer controls quality processes and procedures?
Processes, policies, and procedures, and any associated changes, are managed in a controlled manner, commensurate with the level of risk.
- How Pfizer trains and qualifies its workforce?
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 applicable laws, regulations, and Pfizer policies and procedures.
- How Pfizer monitors product and process quality?
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.
- What happens when Pfizer identifies a quality issue?
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 matters.
- How Pfizer oversees suppliers and manufacturing partners?
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 applicable regulations and Pfizer policies.
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