From Part 1 of this post we highlighted that there is no formal need for a QA Manager or Department in GMP.  EU GMP does require you to have a QA system, but there is no mention of who should manage the system.  In a number of courses that I have presented in the past we have looked at what the delegates think QA’s role should be, bearing in mind the role is not defined in GMP.  Roles already assigned in GMP to the Head of QC and the QP can be delegated to QA, with additional roles added as well. Their findings are below:

The QA Manager (suggested duties from course delegates)

  • Control of Licences
  • Liaison with Research & Development/ New Product Introduction
  • Batch Review
  • Batch Release
  • Management of the Document Management system
  • Management of the Internal Audit system
  • Management of the GMP Training System
  • Customer feedback and satisfaction
  • Management of deviations, incidents and investigations
  • Management of the Validation system
  • Vendor assurance and supplier auditing
  • Control of sub-contractors
  • Performance monitoring and review
  • Management Review
  • Management of the Continual Improvement system
  • Gathering and Trending of quality related data
  • Data storage
  • Management of the Product Quality review process
  • Management of the Risk Management process
  • Management of the Corrective Action system
  • Management of the Preventative Action system

These are roles commonly performed by QA departments.  They are opinions from former GMP training course delegates and should not be seen as a specific GMP requirement.  Please let us know what you think.  Are these similar to your own QA department?