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Quality Assurance

The Quality Unit is a team of pharmaceutical professionals focused on ensuring all products meet strict quality, purity, and efficacy standards required by the US Food and Drug Administration (FDA) and defined in Good Manufacturing Practices (cGMP). 

The Quality Unit is comprised of the Quality Assurance and Quality Control teams who together are responsible for implementing the overall Quality System.
 

The Quality Unit and Quality System are responsible for the following:
 

  • Developing and implementing controls for manufacturing operations so all products made meet in-process and finished product specifications.

  • Writing and implementing procedures and specifications so each process is controlled and repeatable. 

  • Approving or rejecting incoming materials, in-process materials, and finished drug products.

  • Reviewing production records and investigating all discrepancies or deviations

  • Applying control over manufacturing so all operations are properly planned, conducted, approved, and monitored. 

  • Reviewing and approving all raw material vendors.

  • Testing and reviewing or rejecting all incoming components, related materials, labels, and finished products.

  • Ensure procedures and specifications are appropriate and followed during each step in the manufacturing process.

  • Implement controls for each stage of manufacturing

  • Trending and evaluating manufacturing process performance against established specifications

  • Review and approve production and maintenance procedures and associated records

  • Review production records and investigate discrepancies

  • Perform audit of vendors and suppliers

  • Perform internal audits to ensure compliance with FDA requirements across all departments

  • Perform audits of all internal processes and procedures and trend data to ensure compliance

  • Approve or reject incoming materials, in-process materials, and finished products

  • Determine the acceptability of each batch for release

  • Remain independent of product and process development units