Our Policy Statement
Pfizer’s purpose is to innovate to bring therapies to patients that significantly improve their lives. In support of this, we are committed to high standards of Environmental, Health and Safety (EHS) performance. Our success will be judged in achieving the following objectives from our Company’s EHS Policy:
Ensure compliance with all applicable EHS laws in all countries in which the Company operates.
Manage EHS risk and performance effectively; actively seeking and acting upon meaningful opportunities to reduce risk and improve our EHS performance.
Reduce the EHS impact of our products throughout their lifecycle.
Support programs to achieve Pfizer’s environmental sustainability public goals.
Select suppliers and business partners with consideration of their ability to run safe and environmentally responsible operations.
Educate, train and motivate Pfizer colleagues to work in a safe, environmentally responsible manner.
Foster openness and dialog on EHS matters with our stakeholders, both internal and external; communicating risk, performance and progress.
Pfizer’s EHS Policy is implemented through a comprehensive EHS Management System, overseen by governance arrangements that involve all levels of the Company. Our performance is monitored and regularly reviewed to ensure our standards of conduct meet our high expectations, and that the Policy continues to be of value to our business and its stakeholders.
Audits
The purpose of Pfizer’s Global Environment, Health and Safety (EHS) Audit program is to provide an objective assessment of the adequacy of the management of EHS risk at a site level.
Pfizer’s EHS audits add value by:
- Focusing on compliance with Pfizer EHS standards and regulatory requirements.
- Providing a comprehensive assessment of the adequacy of site risk management, including EHS and business continuity risks.
- Outlining a summary of site EHS performance to senior site and business line management, including identification of site management strengths and areas for improvement.
- Engaging site-level EHS professionals to audit at other facilities, maximizing technical knowledge across the network.
- Identifying “best practices and model programs” that other sites can replicate.
- Proposing solutions to close gaps identified during the audit process.
The EHS Audit program applies to all Pfizer internal site locations including manufacturing, research & development, and commercial sites. Refer to details on Pfizer’s Supplier Assessment program. The program is risk based with greater audit activity directed towards higher hazard operations within the Pfizer network of sites. Audit methods deployed vary depending on the audit objectives and feasibility of travel / access to sites. Audit methods include on-site, remote audits enabled by technology, and/or hybrid approaches combining on-site and remote audit techniques. The Global EHS Audit program also includes a review of site Self Audit programs which are conducted by sites and designed to similarly evaluate site level conformance to regulatory and Pfizer EHS Standard requirements.
Product Safety & Quality Standards
Everything we do — including our processes, policies and procedures — are managed in a controlled manner, commensurate with the level of risk. Our comprehensive Pfizer Quality Standards (PQS) include more than 140 standards that apply to Good Manufacturing Practices (GMP) activities. These standards represent mandatory requirements established to ensure compliance with Pfizer expectations and requirements from global regulatory agencies, such as the US Food and Drug Administration (FDA), European Medicines Agency (EMA), the UK’s Medicines and Healthcare products Regulatory Agency, Health Canada, China’s National Medical Products Administration, Japan Pharmaceuticals and Medical Devices Agency (PMDA), Pharmaceutical Inspection Co-operation Scheme (PIC/S), International Council for Harmonization (ICH), Brazilian Health Regulatory Agency (ANVISA), and the World Health Organization (WHO). Our Pfizer Quality Standards are designed to ensure compliance with our scientific, ethical, legal and regulatory obligations. We also expect the same from any third parties who carry out work on behalf of Pfizer. We strive to ensure compliance with not only applicable laws and regulations but also to our own high standards. And we are proud that among our colleagues are subject matter experts and thought leaders who are often asked to review and advise on standards for our industry.
Per Pfizer Quality Standards, all colleagues and contingent workers, whether temporary or part-time, who perform job functions potentially impacting Pfizer Product Integrity must have the appropriate combination of education, training and experience to enable independent performance of assigned tasks. Required training is based on role and responsibility, and role-specific quality and compliance training is added to every colleagues’ core curriculum.
Similar to requirements from global regulatory agencies, we are aligned with The International Standards Organisation (ISO). Some facilities have individually achieved ISO 14001 and ISO 13485.
Supplier Safety & Quality Oversight
Pfizer has a comprehensive oversight program of suppliers, managed by a dedicated Quality organization. This organization oversees the suppliers’ performance on all core compliance and quality system elements, including their site's training system. The Pfizer Quality team ensures that all expectations of suppliers regarding quality and compliance, including their obligations regarding having suitably trained colleagues to perform all job functions and responsibilities, are clearly understood. These expectations are also formally captured in documented Quality Agreements between Pfizer and its suppliers. Pfizer provides support to its suppliers where required, to ensure their knowledge and competencies are adequate to address key quality and compliance subjects. This training covers elements such as investigation skills and process robustness programs. Within Pfizer, all colleagues with supplier oversight have completed a comprehensive training curriculum that is specific to their role, and which is kept updated to reflect current regulatory and quality system knowledge requirements.
Pfizer has well-established, robust, and comprehensive due diligence, selection, and qualification processes for all new suppliers of materials used in production of all Pfizer’s products. All vendors must be qualified and their materials approved for use in commercial product before any associated drug product is distributed on the market. The qualified status of vendors is periodically assessed on a risk-based frequency. This assessment includes periodic audits and comprehensive assessment of various performance data related to the specific vendor. Pfizer also has in place a comprehensive risk management oversight program for vendors which includes multi-functional elements (including procurement, operations, digital, EHS, and quality). Quality agreements are in place with all vendors of materials used in Pfizer’s drug product manufacture, that outline the requirements vendors need to consistently follow to support their continued qualified status within Pfizer’s systems. Similar selection, qualification, and oversight model applies to all of Pfizer’s vendors of any outsourced GMP services. Pfizer conducts periodic audits of suppliers’ systems and performance on all elements including safety, environmental, quality, compliance, and digital. These audits are performed by an independent group of highly experienced auditors on a defined frequency, based on the category of supplier and their risk level. Supplier risks are overseen at senior leadership risk management forums to ensure the appropriate risk management is being applied within Pfizer regarding its suppliers. This helps to ensure the appropriate quality, compliance, and safety of all Pfizer's products on the market. Incremental risk mitigation activities are defined and implemented where warranted.
Compliance
Compliance with all environmental, health and safety laws and our internal EHS Standards is an imperative for the business.
Pfizer’s EHS Management System framework is risk-based and designed to meet Pfizer’s dynamic business and operating model.
Pfizer is committed to enhancing its workplace safety and environmental performance and improving our transparency through reporting. We accomplish this by measuring our performance, setting improvement targets, and disclosing publicly. We also set public goals related to issues of public concern and significance to our business; for example reducing carbon emissions.
Information related to EHS indicators, goals, targets and performance have been compiled into a KPI dashboard.
Pfizer measures, monitors, evaluates, tracks and reports environment, health and safety (EHS) performance metrics considered material to managing our global EHS program and our business. We do this through a combination of data collection and verification, internal audits, facility self-assessments and management system reviews that span the site, functional and corporate levels. We use key performance indicators (KPIs) to measure and externally report our global performance.
Pfizer's scope for data collection is directed by our EHS Standards. With the exception of smaller sources (leased R&D < 50k sq ft and Commercial / Logistics Centers < 100k sq ft), EHS performance data includes Pfizer manufacturing, R&D, commercial and logistics center facilities and excludes outsourced operations. Environmental data is baseline-adjusted in accordance with the Greenhouse Gas Protocol for World Resources Institute's (WRI) Corporate Standard. Facility closures are included in the data set while divested units are not. Injury and illness data does not follow WRI since it is rate-based and is therefore, not baseline adjusted.
Pfizer emphasizes accuracy, transparency and usability when disclosing and reporting our EHS performance. We report annually on key EHS performance indicators, many of which follow Global Reporting Initiative (GRI) guidelines and consider the UN Global Compact Principles
Our external website and Pfizer's annual integrated report, which highlights our financial, environmental and social performance, serve as the primary channels for publicly disclosing our EHS performance. Additionally, we voluntarily participate in various sustainability questionnaires, such as those offered by CDP (carbon, water), Bloomberg (Climate Innovation Index), and Newsweek(Green Rankings)