Qualified Person: Legal Responsibilities and Professional Defense

The Qualified Person (QP) is one of the most exposed roles in the pharmaceutical industry: their signature certifies the compliance of each batch with GMP requirements. Responsibilities range from compliance with Annex 16 to the supervision of suppliers and non-EU imports.

In recent years, several QPs have been fined for releasing non-compliant batches. This highlights the need to carefully document every decision and maintain robust defense procedures.

An effective strategy includes the creation of a QP decision log, archiving of conditional release justifications, and periodic training on Annex 16.

Our QP Guide from GuideGxP provides practical tools such as decision log templates and defensive checklists, making the day-to-day management of the role more confident.

If you're a QP, our guide helps you reduce legal risks and strengthen your career.