
Elan's manufacturing and development capabilities provide a range of client services, including:
Manufacturing: Oral solid dosage forms in bulk or packaged form; controlled substance manufacture in the United States; gateway testing/release; and labeling and packaging.
Engineering Services: Project process, equipment, facilities and utilities.
Laboratory Services: Quality control, raw materials/stability, validation and compliance.
Development Capability: Formulation, analytical development, scale-up and process transfer.
Regulatory: Regulatory dossier preparation, submission and support.
Professional management services at Elan include:
- Project and Portfolio Management: Dedicated project management teams to support products through all stages of development and manufacture
- Global Supply Chain Management: Strategic sourcing, demand planning, package design and control, and contract product procurement
- Site Support Functions: Information technology, finance and human resources.
Compliance
In the period 2002 to July 2007, Elan has undergone successful inspections from various regulatory authorities including:
- U.S. Food and Drug Administration
- Irish Medicines Board
- U.S Drug Enforcement Administration
- Environmental Protection Agency
- Health and Safety Authorities
- Multiple client and consultant audits
Environmental Control and Safety
Environmental
- Dedicated department for management, monitoring and reporting
- Integrated pollution control license
- Facilities in place for waste water, air emissions (particulates, VOC’s), noise control, hazardous waste liquids & solids, surface water retention.
Safety
- Dedicated safety management team
- Full safety management system including, self- inspection, near miss incident reporting and trending, safety meetings and routine health screening on site.
Best-in-Class Systems
Elan's dedication to best-in-class systems underlies its commitment to providing the highest quality service to our clients.
- Enterprise System
- Networks
- NT4
- Oracle database
- Intranet/extranet
- Laboratory Systems
- LIMS
- Chromatographic network system - Millennium
- Dissolution network system - IDIS
- Maintenance Management
- SCADA
- Supervisory Control and Data Acquisition (of processing Group)
- Current and throughout facility
- Automated Warehouse and Dispensary
Packaging
- Vial labelling and cartoning
- Blister
- Bottle