Quality And Compliance

How We Do It      Catalent’s Approach      One Catalent      Quality Policy

As a drug development, delivery and supply partner for the global pharmaceutical and biotech industries, we work every day to provide a broad range of solutions and demonstrate our commitment to excellence in regulatory compliance and quality management. As a leading global provider with more than 50 facilities and a broad range of services and technologies, we maintain a comprehensive Quality Assurance and Regulatory compliance strategy that is continuously reviewed by internal audit teams, regulators, and our customers. We aim to put the patient first in our actions and decisions, and regularly engage in activities to improve standards within our industry, which ultimately drives better customer and patient outcomes.

At Catalent we employ a robust process for partnering with our customers, which includes a transparent, centralized and comprehensive Quality Management System (QMS) program, dedicated audit resources, and regulatory intelligence monitoring. We emphasize a collaborative customer experience and a pro-active approach to communications.

Our focused and disciplined operating mechanisms help to ensure that we are operating in a manner consistent with our values and that our sites remain inspection-ready at all times. Given the breadth of our operations, and projects with hundreds of customers, Catalent is subject to more than 50 regulatory inspections each year and has maintained a solid performance history.

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HOW WE DO IT

Quality Compliance Maturity

• Corporate quality policies and standards that cascade to the business unit facilities and site-specific standard operating procedures (SOPs)
• Listening to and learning from the feedback from customers, as well as local and global regulatory agencies
• Streamlined processes for regulatory actions, including a regular operating mechanism to track:
  • Regulatory inspection activity intelligence
  • Sharing of best practices and site effectiveness evaluations
  • Impact assessment and corrective action verification of regulatory findings across the network of sites as appropriate
  • Shared responses to audit observations
• Monthly regulatory intelligence synopsis shared with site leaders

Operational Excellence

• A robust quality management review process with senior leadership engagement and ownership with weekly, monthly and quarterly performance reviews
• Dedicated internal audit staff that regularly audits each of our facilities to ensure compliance to internal, customer and regulatory expectations
• Proactive analysis of cross-Catalent themes and Catalent-wide preventative actions
• Global quality tracking system for deviation and corrective action preventive action (CAPA) management, laboratory investigations, complaints, change control, and supplier management
• A formal deviation management excellence program
• Implementation of global supplier management programs and quality agreements (between customer and supplier)
• A robust methodology for site inspection readiness assessment and directed actions
• Transparent communication of performance metrics and improvement initiatives with customers

Organization Vitality

• Variety of current Good Manufacturing Practices (CGMP) training programs in place
• Engaging in formal best practice forums, enabling a culture of continuous improvement
• A highly trained, well experienced quality and operations team with a number of certified black belt and green belt leaders within the organization

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CATALENT’S APPROACH TO QUALITY MANAGEMENT

At Catalent, supervisors are purposely present on the production floor every shift. Cross-functional stand-up communication meetings routinely occur to review operational and quality metrics, set priorities, share safety information as well as issues and lessons learned. Weekly operational reviews involving all Site General Managers & Quality leaders and monthly cross-Catalent and cross-business unit reviews with the executive leadership assure that common themes are escalated and addressed. A formal quarterly Quality Management Review is performed to assess the overall effectiveness of the Catalent Quality Management System – identifying and assigning actions for continuous improvement.

Our customers are provided with the same level of transparency, and regular joint reviews are encouraged, including customer-focused inspections, metrics on quality performance, and a customer-specific scorecard. During these collaborative sessions, long-term action plans based on continuous improvement are developed. We are proactive in our communication with regulatory and industry organizations to drive industry improvements, establish policies, and effect change.

We strive to provide our customers with a robust, yet flexible, strategy and are always focused on sustaining compliance and inspection-readiness.

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ONE CATALENT

At Catalent we strive to provide the same experience from site to site. This consistency in conjunction with our stringent processes for achieving excellence allows us to deliver high-quality solutions that will maximize your success. To get a more detailed personal presentation from our quality and regulatory experts, please contact us at info@catalent.com

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QUALITY POLICY

Catalent is a trusted partner and leader in developing, optimizing, manufacturing, and supplying pharmaceutical, biopharmaceutical, cell and gene therapy, consumer health, and beauty products.

We are committed to a Patient First culture through excellence in quality and compliance, and to the safety and reliable supply of our products.

Consistent with our Patient First Culture and Standards of Business Conduct, it is Catalent’s policy to:

• Keep patients at the core of our decision-making to help ensure the safety, reliable supply, and optimal performance of every product we develop and manufacture
• Ensure compliance at all times with all laws and regulations pertaining to product and process quality, safety, and performance requirements
• Meet current industry standards in all countries where the products and services we provide to our customers are offered and/or marketed
• Achieve excellence in quality and compliance through a culture of discipline and accountability
• Ensure data integrity through its entire lifecycle by collecting, documenting, reporting, and retaining data and information in a manner that accurately, truthfully, and completely represents what actually occurred
• Support a culture of continuous improvement in the effectiveness of Catalent’s QMS
• Treat our customers with respect and strive to consistently meet their expectations
• Ensure that quality is the responsibility of each Catalent employee by providing robust and regular training to employees to ensure proficiency in operational functions and understanding of current Good Manufacturing Practice regulations.

These commitments will be met through a documented Quality Management System, routinely reviewed quality objectives, a shared quality culture, and a commitment to performance excellence.

Responsibility and Authority

• The President & CEO is accountable for the application of this policy.
• The overall authority to implement this policy is the responsibility of the SVP of Quality & Regulatory Affairs, who is appointed to serve as the QMS management representative.
• Leaders with executive responsibility for a business unit and managers at each location within Catalent are also accountable for compliance with this policy and shall ensure that QMS management representatives for their operations have been appointed.
• Each Catalent employee is responsible for compliance with this policy.