Quality in Action

QC supervisor smiling in PPE.

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
Battery backup

For all critical equipment and systems

generator backup
Generator backup

For the entire facility

data integrity
Data integrity

Backed up three times

data security
Data security

Protected from intrusion and ransomware

redundant pumps
Redundant pumps

On critical systems for zero downtime

hvac
Modular HVAC

Highly zoned HVAC for superior filtration

247 parts
24/7 spare parts

For maintenance across all systems

American Injectables employee operating equipment in full PPE.

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

Don’t take our word for it

Ask us for more proof. We’ll be happy to show you how we deliver.
Smiling American Injectables employee.