Quality in Action
More than talk
Everyone claims to deliver quality because it's easy to say. Here’s how we actually produce consistent results.
\Uncompromising standards
- Safe and effective products throughout their lifecycle
- Adherence to regulatory requirements
- Current Good Manufacturing Practices (cGMPs)
\Systems and contingencies
- Competence, awareness, and training
- Robust quality system
- Functional capabilities in the right positions
- Business continuity plan
\Quality by design
- Quality risk management
- Management review and quality planning
- Process performance and product quality monitoring
- Change control, investigations, and CAPA
- Training and competency
- Continuous improvement
Protect your investment
We play the “What if?” game so you never have to. American Injectables runs a fully self-sufficient operation with integrated critical utilities.
Battery backup
For all critical equipment and systems
Generator backup
For the entire facility
Data integrity
Backed up three times
Data security
Protected from intrusion and ransomware
Redundant pumps
On critical systems for zero downtime
Modular HVAC
Highly zoned HVAC for superior filtration
24/7 spare parts
For maintenance across all systems
No blindspots
We control and monitor every piece of equipment in our entire facility with custom plant management software — from the fan speed on a cooling tower to the infeed sensor on our vial line. Plus, our system offers:
- Database analytics and trending
- Fully electronic maintenance and asset tracking
- Cost-saving efficiencies