The contracted Qualified Person supports you by taking the entire responsibility for product quality, batch certification and batch release for sale according to the applicable national regulations.

The contacted Qualified person will also support your company for the implementation and optimization of projects and for a variation of aspects related to the compliance such as:

  • Manage and assure continuous improvement of the pharmaceutical quality management system (QMS)
  • Act as primary contact during Competent Authority inspections
  • QA liaison with contract manufacturing organizations or third-party logistic providers
  • Handle quality complaints, rejects, reworks, returns, recalls, change control, deviations and CAPAs
  • Perform GMP/GDP compliance gap analysis and interact with other departments
  • Perform GMP/GDP/QMS self-inspections and external audits
  • Ensure inspection readiness

There are real advantages for small companies to engage a contracted Qualified Person. For example:

  • Avoid any issues related to personal fluctuation (ensure long term relationship with the authorities)
  • Cost benefit (part time job)
  • Sounded knowledge in the relationship with the authorities