Sourcing Center

Fees

Fee and payment terms will be outlined in your specific proposal. Catalent strives to meet your business needs with flexible business models.

Formal project management systems

Catalent understand the need for projects to run smoothly, stay within budget, and arrive at market reliably and on time. Managing across the entire lifecycle of your product, we use operational Excellence Lean Six Sigma principles to streamline communications to a single point of contact and maximize production to create a more flexible, direct route to market. With our technological innovations, expert teams, and advanced equipment, we help save you time and money by maximizing your product’s benefits early in development and thus speed your path to market. Backed by an interconnecting network of global facilities and standardization of policies and agreements, we are able to supply you with the highest quality of goods and services at any stage of development, anywhere in the world – even with late-stage customization. 

Procurance of raw materials and components

Catalent’s customers typically supply active pharmaceutical ingredients. Catalent can procure other materials if required.

Current operating hours

Most facilities operate 5 days per week, up to three shifts per day, weekends as required

Scheduling

Catalent must receive a signed quotation, a signed protocol and all raw materials/intermediates/final product samples in order for a project to be scheduled.

Lead time and timing of forecasts

Our commercial process calls for a rolling forecast to be provided on a monthly basis, with a firm forecast period of 3-4 months; pre-commercial manufacturing lead times are project dependent.

Site management of technology transfer

Our new product development organization contains a sub-team responsible for tech transfer activities. A program manager coordinates a cross-functional team (technical operations, operations, quality) to manage tech transfer activities. Each product goes through a defined technical review process before moving to commercialization.

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.

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

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.

Regulatory approvals obtained

FDA, MHRA, and authorities from a variety of countries in Asia, South America, Australia, etc.

Government inspections in last five years

• August 2003 FDA inspection-NAI (No Observations)
• April 2004 FDA Inspection-CBE30 (No Observations)
• August 2004 AFSSAPS-GMP Inspection (13 Deficiencies)
• August 2004 MHRA-Gmp Inspection (17 Observations)
• August 2004 FDA-GMP Inspection (9 Observations)
• March 2005 ISO Certification Assessment (No Observations)
• January 2006 Mexican Authorities GMP Inspection (No Observations)

• February 2006 Team Biologics-GMP Inspection (4 Observations)
• April 2006 FDA Directed Inspection (No Observations)
• April 2006 ISO Certification Assessment (No Observations)
• March 2007 FDA-GMP Inspection (11 Observations)
• April 2007 ISO Certification Assessment (6 Observations)
• August 2007 MHRA-GMP Inspection (12 Observations)

Measuring performance

We track key service and quality metrics (e.g., on-time delivery, BRNRFT, etc.), which are reviewed in regular update meetings (generally quarterly) to identify areas for improvement. 

Formal customer complaint resolution process

A corporate quality policy is in place for complaint resolution along with site SOPs that can be reviewed at an audit.

Environmental licenses

We have received all required environmental licenses.

Disposal of wastes

Waste is disposed of in accordance with all local and federal/national regulations.

Fire standards

All facilities globally meet local fire protection standards. Facility diagrams by site can be provided during audit. 

Chemical protection

Many of our facilities have industrial hygiene programs in place; other facilities are in process of gathering IH data. We also have a safety-training program for employees. 

Facility coverage

We have a $300M property program underwritten by 3 carriers with different levels of participation. Our lead property underwriter is Chartis (formerly AIG/AIU) followed by Star Tech and Munich Re. Catalent employs a property loss control program (engineering services) for all covered locations, and site visits are prioritized on an annual basis. 

Workmen’s compensation

Catalent carries Workmen’s Compensation insurance with state statutory limits and a $500k deductible. We also carry U.S. General Liability insurance with a $2M each occurrence limit and a $4M general aggregate limit with a $100k deductible.

Loss prevention

Third-party loss prevention engineering assessments are conducted by Starr's Technical Risk Agency and FM Global annually.

Approach

We are firmly committed to supporting diversity within our supplier base. For more details see Supplier Diversity.