Johnson & Johnson Quality Management Framework, Exams of Quality Management

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Quality at

We blend heart, science

and ingenuity…

…to profoundly change the

trajectory of health for humanity.

Foreword

Quality at the Forefront

At Johnson & Johnson, ALL employees are responsible for Quality. We believe good health is the foundation of vibrant lives, thriving communities, and forward progress. That is why for more than 130 years, we have aimed to keep people healthy at every age and every stage of life. Today, as the world’s largest and most broadly-based healthcare company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body, and environment within reach of everyone, everywhere. We blend heart, science and ingenuity to profoundly change the trajectory of health for humanity. To continuously assure this vision, Johnson & Johnson puts high quality as a shared priority for all J&J associates.

Our approach to managing Quality is through the Johnson & Johnson Quality Management Framework or QMF. It includes our Commitment to Quality, as set forth in Our Credo, our Quality & Compliance organization, and our system of policies, standards, and procedures designed to achieve end-to-end compliance with customer and regulatory requirements for Quality Management Systems across Johnson & Johnson. The Johnson & Johnson Quality Policies & Standards across our Family of Companies cover the lifecycle of our products from research and development to the consumer and patient experience. These Policy Standards provide a common foundation of quality expectations and help to ensure a reliable supply of high-quality products across all our business segments. The Quality Policy Standards set expectations for all Johnson & Johnson companies to achieve.

In 2021, we continued to assess and improve our internal quality policies and standards to keep pace with the changing regulatory demands for our diverse portfolio of products. This positions

Johnson & Johnson to leverage emerging technologies and better serve our customers, we undertook a program to improve clarity, map requirements to applicable regulatory requirements, and incorporate Health Authority expectations while enabling flexibility for our diverse business segments. This restructuring of our policy standards resulted in the addition of six new Quality Policies that better reflect the lifecycle of our products. These quality policies and standards focus on our commitment to continued Compliance to Regulations, Simplification of processes and procedures across our businesses, focused Applicability to the intended audience, Traceability to requirements, and Flexibility to enable innovation within the organization. These are the key elements that make our Quality Management Systems customer-centric, provide continuous improvement, and incorporate Quality as a universal discipline that raises the bar for all to attain.

As stated in Our Credo, “We believe our first responsibility is to the patients, doctors and nurses, to mothers and fathers and all others who use our products and services. In meeting their needs, everything we do must be of high quality.” Therefore, Quality is at the forefront of our strategic priorities and shapes the Quality culture at Johnson & Johnson for continued success now and in the future.

Carol Montandon Chief Quality Officer (CQO) Johnson & Johnson

Joaquin Duato Chief Executive Officer Johnson & Johnson

1. Introduction to the

Johnson & Johnson

Quality Management

Framework

1.1 Purpose

This Johnson & Johnson Quality Management Framework provides an overview of the Quality archi- tecture for Johnson and Johnson. Specifically, the QMF outlines how quality is managed within Johnson & Johnson and includes the Quality & Compliance organization, the roles and responsibilities, and the policies, standards, processes, and procedures that establish requirements for end-to-end compliance to the Quality Management Systems across Johnson & Johnson.

Scope

The management of Quality applies to ALL areas within our Business and Functional units. This includes, but is not limited to, research, design and development, clinical, sourcing, supply, validation/ qualification, production, packaging, labelling, operations, laboratory and testing, product release, storage, transportation, distribution, installation, service, marketing, and post-market surveillance.

Table of Contents

Quality Values

1. Introduction to the Johnson & Johnson Quality Management Framework Table of Contents

We build trust by focusing on Culture,

Capabilities, Compliance and Customers.

Culture

Culture is the cornerstone of Quality. We drive quality in a positive and proactive way. At Johnson & Johnson, we have a customer-focused, Credo-centered mindset, and our leaders set the tone at every level.

Capabilities

We empower our Research & Development, Supply Chain, and Commercial teams to design, make, and deliver the right product with the right performance, every time. The scale of Johnson & Johnson is leveraged to fuel innovation and designed to achieve more competitive products, technology, and process quality.

Compliance

Everyone must understand their role in ensuring quality at Johnson & Johnson and getting it right the first time is a priority. To assist with this goal, we have Johnson & Johnson Quality Standards to ensure compliance to regulation, drive consistency, and reduce risk. We focus on the continuous improvement of our products and services to set the benchmark.

Customers

All of our actions have a direct impact on our ability to help people around the world live longer, happier, and healthier lives. We listen to our customers to understand what’s important and enable quality solutions to drive value and enhance the customer experience.

p.

Our Credo.

We believe our first responsibility is to the patients, doctors and nurses, to mothers and fathers and all others who use our products and services. In meeting their needs everything we do must be of high quality. We must constantly strive to provide value, reduce our costs and maintain reasonable prices. Customers’ orders must be serviced promptly and accurately. Our business partners must have an opportunity to make a fair profit.

We are responsible to our employees who work with us throughout the world. We must provide an inclusive work environment where each person must be considered as an individual. We must respect their diversity and dignity and recognize their merit. They must have a sense of security, fulfillment and purpose in their jobs. Compensation must be fair and adequate and working conditions clean, orderly and safe. We must support the health and well-being of our employees and help them fulfill their family and other personal responsibilities. Employees must feel free to make suggestions and complaints. There must be equal opportunity for employment, development and advancement for those qualified. We must provide highly capable leaders and their actions must be just and ethical.

We are responsible to the communities in which we live and work and to the world community as well. We must help people be healthier by supporting better access and care in more places around the world. We must be good citizens — support good works and charities, better health and education, and bear our fair share of taxes. We must maintain in good order the property we are privileged to use, protecting the environment and natural resources.

Our final responsibility is to our stockholders. Business must make a sound profit. We must experiment with new ideas. Research must be carried on, innovative programs developed, investments made for the future and mistakes paid for. New equipment must be purchased, new facilities provided and new products launched. Reserves must be created to provide for adverse times. When we operate according to these principles, the stockholders should realize a fair return.

Visit www.jnj.com/credo/ to learn more about Our Credo.

2. Commitment to Quality Table of Contents

3. Johnson & Johnson

Organization

Johnson & Johnson was founded in 1886. It has since grown to become one of the world’s largest and most broadly-based healthcare companies.

→ Johnson & Johnson conducts business in virtually all countries of the world with the primary focus on products related to human health and well-being.

→ Over 140,000 employees across the globe work every day to help transform healthcare.

→ Over one billion lives are touched every day by a Johnson & Johnson product or service.

The Johnson & Johnson Family of Companies is orga- nized into Segments (Pharmaceutical, MedTech and Consumer Health). These Segments have decentral- ized businesses, including individual Operating Com- panies or Franchise management structures that may execute or support functions such as Research and Development, Sales and Marketing, Regulatory Af- fairs, or other activities regulated by health authorities. Certain functional expertise may be managed at the Johnson & Johnson Enterprise level, such as Informa- tion Technology (IT) and Human Resources. These En- terprise-level functions are managed through a combi- nation of centralized capabilities and business-facing support. Collectively the Segments with all supporting Enterprise-wide and Functional units comprise the Johnson & Johnson Enterprise.

Table of Contents

Major Enterprise-Level Functions

Johnson & Johnson Supply Chain (JJSC)

Johnson & Johnson Supply Chain includes three business sector supply chains—Pharmaceuticals, MedTech and Consumer Health—that cover planning, sourcing, internal and external manufacturing, as well as the Supply Chain Strategy, Innovation & Deployment organization, and the Deliver organization, which manages distribution and customer service. Additional enterprise-wide functions that are part of the Johnson & Johnson Supply Chain include Environmental Health, Safety & Sustainability, and Engineering & Property Services.

Medical Safety Office and Regulatory Affairs

The Johnson & Johnson Office of the Chief Medical Officer is a global group of medical and scientific professionals focused on advancing evidence- and science-based decision-making that is driven by bioethical principles and values.

The Regulatory Affairs organization provides regulatory expertise to all J&J businesses on the development requirements, regulatory submission requirements, and approval process for J&J products. This group is responsible for ensuring all product registrations and approvals are accurate and current. Regulatory Affairs also ensures that all product labeling meets the regulatory requirements for each market that a product is distributed.

Quality and Compliance

The Quality and Compliance function provides end-to-end support to all Business and Functional units to ensure that product is designed, manufactured, and delivered with high quality and in compliance with regulations.

3. Johnson & Johnson Organization Table of Contents

4. How Johnson & Johnson

Manages Quality

Johnson & Johnson manages Quality through its Quality organizational roles and responsibilities, pol- icies, standards, processes, and procedures. This is referred to collectively as the Quality Management Framework. There are individual Quality Management Systems throughout the Business and Functional Units that are supported by Senior Management. Senior Management within Johnson & Johnson is the highest level of management with the responsibility, authority, and control of resources to define, implement, and/or modify the structure, policies, procedures, processes, and practices of the organization(s).

Senior Management ensures the Quality and Compli- ance function has key decision-making and oversight responsibilities for all Quality Management Systems across the Enterprise. However, responsibilities from Management down to the employee level are applied so that every employee has a responsibility to Quality.

Table of Contents

5. The Role of Management Table of Contents

Plan

→ Quality Planning – Management establishes the organization’s Quality plan, goals, and objectives and cascades these expectations throughout the organization to ensure all employees are engaged in the quality priorities. Management at all levels of the organization ensures Business and Functional unit quality plans and objectives align with business strategies and the Quality Policies.

→ Resource Management – Management of each Business and Functional unit identifies resource requirements and provide resources, infrastructure, and qualified personnel to establish, maintain, and improve the elements of the quality system. This includes Quality Planning through implementation.

→ Management of Outsourced Activities – Management ensures there are processes in place at each Business and Functional unit to control, review, and ensure all outsourced services (including external manufacturing and suppliers that are executing GxP activities) are in compliance to applicable regulations.

→ Acquisitions and Divestitures – Management of each Business and Functional unit will ensure that appropriate resources and processes are established to assess and manage the quality and compliance responsibilities for Acquisition and Divestiture of products, services, and companies.

Monitor

→ Management Review –The performance of the individual business units within Johnson & Johnson is reviewed and monitored by Management. Management Reviews are documented and include monitoring of key metrics, adequacy of the QMS, the potential impact identified risks, and actions taken to mitigate risks. The output of Management Reviews is used to define corrective and preventive actions for continuous improvement and annual Quality Planning.

→ Quality Monitoring –Quality oversight and on-going monitoring are performed by Business and Functional units to identify and mitigate risks. Feedback is provided to appropriate Management throughout product lifecycle to ensure continuous improvement of the individual Quality Management Systems.

Communicate

→ Escalation and Internal Communication – Management of each Business and Functional unit implements effective communication processes at all levels. A formal escalation process is established to notify Quality Management and, if required, applicable Health Authority and Regulatory Agencies of significant product quality, regulatory compliance, and quality system issues throughout product lifecycle.

6. Quality Organization

& Governance

Quality Organization

The Johnson & Johnson Quality & Compliance (J&J Q&C) organization has a worldwide presence in pharma- ceuticals, medtech and consumer health, ensuring that products are designed, manufactured, and delivered effectively. Quality management has a significant role within Johnson & Johnson and is represented on each Company Global Operating Committee and within each Business and Functional unit. Quality Management has the responsibility and authority to ensure that quality system requirements are effectively established and maintained within the respective organization.

Quality and regulatory compliance issues are escalated, and the performance of the quality management system is reported to the Johnson & Johnson Chief Quality Officer. The Quality & Compliance organization is indepen- dent of all other business functions and is the ultimate decision-maker for the applicable Market Authorization Holder in all matters of quality and regulatory compliance. An independent audit function within Quality pro- vides compliance oversight to deliver early detection and mitigate quality and compliance risks throughout the entire organization.

Table of Contents

Chief Quality Officer (CQO) Johnson & Johnson

CQO Consumer

Communication Finance IT Legal Human Resources

CQO Pharmaceuticals

Regulatory Compliance

Microbiological Quality & Sterility Assurance

Enterprise Quality

BioResearch Quality & Compliance

CQO MedTech

Segment Chief Quality Officer

The Quality organization for each Segment is led by a Chief Quality Officer (Segment CQO) who reports directly to the Johnson & Johnson CQO and monitors the individual Quality Management Systems for their respective Segments. The Segment CQO responsibilities include:

→ Assuring Segment procedures are in place that align with Johnson & Johnson Quality Policies and Standards;

→ Establishing quality plans and goals/objectives for the Segment;

→ Managing resources to effectively execute and monitor the quality plan and goals/objectives for effectiveness throughout the Segment; and

→ Communicating quality needs, performance, and risks to the relevant Segment Group Operating Committees and to the Johnson & Johnson CQO.

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Enterprise-wide Quality Functions

Enterprise-wide Quality Functions provide quality governance and services to support Business and Functional units throughout the Enterprise. These functions consist of Regulatory Compliance and Enterprise Quality.

Regulatory Compliance

The Regulatory Compliance function provides independent oversight and guidance across the Enterprise. This function supports regulatory compliance activities, performs internal/external audits, supports monitoring/verification of Corrective and Preventive Action (CAPA), and remediation activities. This team also includes Enterprise-wide Standards Management, which provides effective regulatory outreach and communicates compliance risks to executive management.

6. Quality Organization & Governance

Table of Contents

Enterprise Quality

There are several teams that provide enterprise quality support and services to our businesses. These include: Enterprise and Commercial Quality, Supplier Quality Reliability, Technology Quality and Emerging Technologies.

→ Enterprise and Commercial Quality continuously improves Quality processes across Enterprise and Regional Commercial/Deliver organizations to advance Customer Experience.

→ Supplier Quality Reliability delivers improved processes, digital solutions and data analytics in the supplier lifecycle management.

→ Technology Quality accelerates and enables technology solutions and ensures the overall strategy for validation/qualification of applications and infrastructure.

→ Emerging Technologies acts as a catalyst across the segments to accelerate our quality strategy through digital enablement.

6. Quality Organization & Governance

Responsibilities for Key Processes

Each Johnson & Johnson Business and Functional unit is responsible for ensuring that all procedures and processes related to monitoring and improvements for products comply with the Johnson & Johnson Quality Standards and applicable regulations. Key systems with defined requirements are in place to monitor quality processes within the Business and Functional units.

Key Processes:

Table of Contents

Regulatory Notification and Monitoring

Current, new, and proposed regulatory agency requirements and industry standards are monitored for impact to Johnson & Johnson Quality Standards, filings, registrations, clinical protocols, submissions, business operations/activities, and products. Health authority and regulatory changes, requirements, and trends are communicated to Management.

Field Action & Recall Management

Patient and consumer safety are a top priority for everyone at Johnson & Johnson. As a result, Johnson & Johnson has a system in place to assess alleged product issues. If required, product recalls, product withdrawals, product corrections, or any other product specific actions affecting product quality or regulatory compliance are taken in accordance with all regulatory requirements. All decisions on field actions are taken independent of commercial/business influence by a Quality Review Board (QRB), which is composed of Quality, Medical Safety, Medical Affairs, and Regulatory Affairs leadership. These actions are documented and communicated to Health Authorities in a timely manner.

Complaint Handling

Product complaints are documented, managed, investigated, and reported. Product complaints are promptly evaluated for possible reportability to health or regulatory authorities, and appropriate notifications are initiated. Trends are monitored, and triggers are established to allow escalation of Significant Quality Issues.

Vigilance and Post-Marketing Surveillance

Johnson & Johnson has a program in place to identify, assess, document, and report Adverse Events and undesirable effects during all phases of the product lifecycle, including clinical trials, as required by applicable regulation. This includes the monitoring of trends and the establishment of triggers to allow escalation of Significant Quality and Safety Issues.

A post-market surveillance system is in place to collect, record, and analyze relevant data on the quality, performance, and safety of a product throughout its entire lifecycle.

6. Quality Organization & Governance

Table of Contents

Change Control/Change Management

Change Management is important for GxP activities and is applied throughout product lifecycle (research through discontinuation). A documented systematic process is in place to propose, evaluate, approve, implement, and review changes in a controlled manner. The process provides a consistent mechanism for documentation and evaluation of changes and defining requirements that must be satisfied prior to the implementation of changes.

Nonconformances and Corrective/ Preventive Action

Investigations to determine the root cause or assignable cause of each nonconformance related to product, processes, and the quality system are conducted using root cause analysis methodologies. These investigations are documented, tracked, and trended.

Corrective and Preventive Actions (CAPA) are established to manage and document the correction of a nonconformance (corrections), eliminating the root cause of a nonconformance (corrective action) and preventing the occurrence of a nonconformance (preventive action) with an evaluation of effectivity.

Periodic Product Review

Product reviews are conducted and documented per Johnson & Johnson Quality Standards and as specified by Health Authorities to assess process performance and suitability of product specifications, evaluate manufacturing or process controls, detect trends, and identify steps for corrective action and/ or continuous improvement. The elements specified in the Product Review are analyzed and compared to the results of previous reports and all regulatory requirements.

Audit Management

The Johnson & Johnson Audit program (applicable to internal companies and external suppliers) monitors the effectiveness of the quality system and ensure compliance to the Johnson & Johnson global standards and worldwide Health Authority requirements. Audits are performed per a defined audit schedule utilizing a risk-based approach.

Document and Data Management Controls

Johnson & Johnson has a documentation system to ensure control of quality procedures and records. The documentation system includes processes for the identification, creation, review, approval, distribution, implementation, storage, retention, and control of all quality systems and product requirement documents.

Data and quality records and information considered fundamental and necessary to continue operations follow GxP requirements and are protected and controlled throughout the data lifecycle, from initial generation through processing, use, data retention, archive, retrieval, and destruction.

6. Quality Organization & Governance