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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 everyday to provide the broadest range of solutions with excellence in global regulatory compliance and quality management. As a leading global provider with 24 facilities and a broad range of services and technologies, we maintain a comprehensive assurance and 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 quality management system (QMS) program, pro-active customer outreach, and participation in establishing future standards within our industry.
Our focus and disciplined operating mechanisms around everyday inspection readiness has proven itself. In more than fifty of the regulatory inspections that occurred globally across the Catalent network in the last 12 month period we have achieved:
- Zero critical observations
- Zero observations of any kind in half of the inspections
- Average observation rate 70% better than industry average
How We Do It:
- Senior executive team engagement and ownership – weekly and monthly review of regulatory activity and outcomes with site leaders
- Corporate quality policies and standard operating procedures that cascade to business unit as well as site-specific SOP’s
- Dedicated staff for internal audit programs
- Proactive analysis of cross Catalent themes and Catalent wide preventative actions
- Robust root cause analysis and an effective corrective action preventive action (CAPA) system
- Variety of cGMP training programs in place
- Constant scrutiny from customers, local and national regulatory agencies globally
- Streamlined processes for regulatory actions including a bi-weekly 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 and employment of lean processes and tool
- Ability to work with highly experienced and highly trained staff
- Number of certified black belt leaders within the organization
- Centre of Excellence for Validation leverages internal and industry best practise
- Implementation of supplier management programs and quality agreements (between customer and supplier)
- Outstanding inspection history from numerous global regulatory authorities
- Transparent communication of performance metrics and improvement initiatives with customers
Catalent’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 go over 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 ensures common themes are escalated and addressed, and a formal quarterly Quality Management Review assesses 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 – inspection activity, quality metric performance are provided, a customer specific scorecard and discussions can be included.
During these collaborative sessions long term action plans based on continuous improvement are developed. We are increasingly proactive in our communication with regulatory and industry organizations relative to industry improvement, establish policies, and effect change.
We strive to provide our customers with a robust yet flexible strategy and show our customers that we are inspection ready at all times. It is this approach that fosters open communication and allows us to maintain a culture of transparency.
In fact, we share our expertise with our customers globally with expert Regulatory Consulting service offering designed to help them overcome regulatory hurdles, prepare their products for launch and face into the complexities of international regulatory regimes.
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 or arrange an appointment with our Regulatory Consulting experts please contact us at info@catalent.com.
