Quality Unit Roles and Responsibilities



  • Quality Unit : The term used to describe the all encompassing roles and responsibilities of the Quality Assurance and Quality Control departments
  • Quality Assurance Unit : That portion of the Quality Unit that sets policies, procedures and specifications, audits, reviews, assessments, provides training and is responsible for the approval or rejection of active pharmaceutical ingredients (APIs) and pharmaceutical (drug) product. It works in concert with, and as a check on the Quality Control Unit
  • Quality Control Unit : That part of the Quality Unit that is responsible for the ongoing control of quality within the company. It is responsible for the acceptance, quarantining or rejection of incoming raw materials and packaging components, conducting in-process tests, labelling and inspection.

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