Quality

Quality is part of every aspect of our company. The Allegiant Health Quality Assurance Team monitors the consistency, efficacy and safety of the manufacturing processes and ensures that procedures and products meet or exceed all cGMP standards required for FDA approval. In addition, company protocols, training and assurance programs make certain every aspect of business is operating to Allegiant Health’s standards of service and execution. Read our Quality Case Study here.

Quality Assurance & Testing

Quality assurance and testing is a top priority at Allegiant Health. Every year we invest significant resources into extensive training programs making certain our associates achieve the highest levels of quality execution in operations and ensuring that premium, high-quality products will be consistently manufactured.

Allegiant Health’s operational activities are constantly monitored by the company’s Quality Assurance Team, ensuring complete conformance with cGMP standards, as required by the FDA. The consistency, efficacy and safety of Allegiant Health’s manufacturing processes are accomplished by implementing industry-leading, comprehensive quality assurance protocols. The company’s QC Laboratory is equipped with a variety of highly sophisticated instrumentation and technology including: High Pressure Liquid Chromatography (HPLC), Infrared Spectrophotometry (IR), Ultra Violet-Visible Spectrophotometry (UV-Vis), Dissolution Apparatus and Accelerated Stability Chamber. All product testing is performed according to official compendia and the highest industry standards.

Allegiant Health’s Quality Assurance and Testing Protocols feature:

  • cGMP compliance and investigational testing
  • Quality assurance validation and documentation
  • Raw materials and finished product testing
  • Validation and stability testing

Quality Control

The Quality Control Laboratory is a key component and the centerpiece of Allegiant Health’s commitment to quality. This state-of-the-art facility is fully equipped with advanced instrumentation including: HPLC, UPLC, GC, Dissolution, FTIR, Atomic Absorption Spectrometer and Fluorescence Spectrometer. The lab has an exceptional staff of chemists and scientists with educational pedigrees ranging from BS degrees to PhDs.

The primary lab functions are focused on quality control of raw materials and finished goods including:

  • Analytical method development and validation
  • Verification of compendial and non-compendial analytical procedures
  • Stability programs under accelerated and room temperature
  • Analytical support for drug development
  • Process and cleaning validation

Regulatory Affairs

Allegiant Health is fully compliant with all applicable State and Federal regulations. The company is a registered and audited cGMP facility. Other regulatory specific data points:

  • FDA: Code of Federal Regulations Title 21, Part 211; current Good Manufacturing Processes for Finished Pharmaceuticals
  • Certified through UL’s (formerly STR/Shuster) “Retail Certification Program” and holds the A-CLASS and STR-R cGMP OTC Drugs Registered Marks
  • FDA CDER Facility Number: 3001195380
  • FDA FSAN Facility Number:  10931458166
  • New York State Board of Pharmacy Facility Number: 030595

If additional information is required, please contact our Customer Service Department.