QA Function

• QA Functions:

  1. Responsible for assuring quality policies are followed
  2. Quality Monitoring or Auditing
• Serves as contact with regulatory agencies, like FDA and DOH

  Responsible for assuring quality policies are followed
• Final authority for product acceptance of rejection

  Responsible for assuring quality policies are followed
• Helps to identify and prepare the necessary SOPs relative to the control of quality


  Responsible for assuring quality policies are followed
• The product meets all the applicable specifications

  Responsible for assuring quality policies are followed
• It was manufactured according to internal standards and GMPs

  Responsible for assuring quality policies are followed
• Determines that the procedures are current and correct


  Quality Monitoring or Auditing
• Procedures are being followed by properly trained operators


  Quality Monitoring or Auditing
• Determines whether the equipment, facilities and operations are adequate and conforms to standards set by regulatory agencies.

  Quality Monitoring or Auditing
• Continually assess operations within the organization

  Quality Monitoring or Auditing
• As advisory toward full compliance with all applicable internal and external regulations


  Quality Monitoring or Auditing