Quality And Compliance

Achieving Optimal Regulatory Compliance and Quality

In our position as the #1 drug development, delivery and supply partner for the global pharmaceutical and biotech industries, we work every day to provide the broadest range of solutions with excellence in global regulatory compliance and quality management.  As a leading global provider with 28 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.

Here at Catalent we employ a robust process for partnering with our customers, which includes a transparent, centralized Quality Management System (QMS) program, pro-active customer collaboration and communication, Regulatory Intelligence monitoring and participation in establishing future standards within our industry.

Our focus and disciplined operating mechanisms around everyday inspection readiness have proven themselves. In the regulatory inspections that occurred globally across the Catalent network in a recent 24-month period:

  • 24 different regulatory authorities have inspected Catalent sites
  • Roughly 50% of inspections resulted in zero observations
How We Do It:
  • Senior executive team engagement and ownership – monthly review of regulatory activity and outcomes with site leaders
  • Corporate quality policies and standards that cascade to the business unit facilities as well as site-specific standard operating procedures (SOPs)
  • Dedicated internal staff that regularly audit different aspects of our compliance programs
  • Proprietary methodology for Inspection Readiness Risk Assessment; tool reported monthly for all sites
  • Monthly regulatory intelligence synopsis shared with site leaders
  • Pro-active analysis of cross-Catalent themes and Catalent-wide preventative actions
  • Weekly review with our regional site teams of deviations and how Catalent is managing the investigations and the related corrective and preventative actions
  • Variety of current Good Manufacturing Practices (cGMP) training programs in place
  • Constant scrutiny from customers, local and national regulatory agencies globally
  • Streamlined processes for regulatory actions, including a regular operating mechanism to track:
    • Regulatory inspection activity
    • Sharing of best practices and site effectiveness evaluations
    • Shared responses to audit observations 
  • Timely response to regulatory agency observations
  • A continuous improvement culture
  • A highly trained, well experienced quality and operations team with a number of certified black belt leaders within the organization
  • Implementation of global supplier management programs and quality agreements (between customer and supplier)
  • Transparent communication of performance metrics and improvement initiatives with customersCatalent’s Approach to Quality Management

Internally, operational metrics, including Quality metrics, are reviewed daily, weekly, monthly, and quarterly. Here at Catalent we begin with walking the production floor every morning to review site quality and operations. There is a weekly operating review involving all Site General Managers & Quality leaders, a monthly cross-Catalent and cross-Business Unit review with the Executive Leadership Team to assure that common themes are escalated and addressed, and a formal quarterly Quality Management Review 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 customer/ Catalent reviews are encouraged – including customer-focused inspections, metrics on quality performance, and a customer-specific scorecard and discussions.

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 relative to industry improvement, establishing policies, and effecting change.

We strive to provide our customers with a robust yet flexible strategy and show our customers that we strive to sustain compliance and are inspection-ready at all times.  It is this approach that fosters open communication and allows us to maintain a culture of transparency.

One Catalent

Here at Catalent we strive to provide you with 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