Quality Assurance & Quality Control

Quality is the foundation of everything that we do at Ameridose. Our unsurpassed quality is driven by two key concepts, Quality Assurance and Quality Control, and, at Ameridose, these concepts are tightly linked to USP<797> and cGMP requirements.

  • Our strict Quality Assurance systems include novel processes and rigid controls that are set in place to build quality into our preparations from the start, preventing defects before they can occur.
  • Ameridose also subjects preparations to rigorous Quality Control processes that involve testing and verification prior to release.

Ameridose Quality Assurance and Control Systems
SOPs and Documentation
  • SOPs in place for every process from receipt of incoming materials through production, packaging and shipping to ensure consistency and conformity
  • Formulary worksheets detail and document preparation of each product
  • Experienced Quality Assurance professionals complete, collect, review, and store all documentation associated with every facet of operations
Environmental Control
  • Validated, calibrated, and certified equipment
  • Continuous monitoring of clean room environments, HVAC controls, surfaces, and air quality
  • Rigorous cleaning program utilizing rotational disinfection
  • Clean rooms and hoods are routinely certified to ensure ISO 14644 compliance
Personnel Control
  • Multi-level didactic training program consisting of procedural review, task-based training, and proficiency evaluation
  • Media-fills and glove-tip monitoring to ensure proper aseptic technique
Process Validation
  • Each process tested for physical, chemical, and microbiological attributes against rigorous specifications
  • Media-fills performed for each process to ensure proper aseptic controls
Finished Product
  • Rigorous stability program to ensure the products meet USP requirements throughout the life cycle of the products
  • Multi-layered quality control verification process to ensure each unit is made correctly and to the highest standards
  • Product verification to ensure that final preparation meets specifications; all finished preparations are checked by a pharmacist
Continuous Process Improvement
  • Process improvements approached from both a tactical and strategic perspective
  • Real-time corrective and preventative actions based on in-depth root cause investigation ensure immediate remediation of issues
  • Ongoing trending for all quality systems evaluate data from a broader perspective to implement change from a strategic perspective

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