Covering Global Pharmaceutical Regulations in a Quality System

This article describes how to address compliance with a wide range of applicable regulations within a company's quality system. The focus is on the way regulatory intelligence can be obtained and subsequently be interpreted within the quality system. Roles and responsibilities of those involved are also discussed.

Regulatory agencies try to harmonise regulations regionally and to some extent globally, but that still requires a lot of work. To remain up-to-date with the Good Practices, i.e. remain in a continued state of compliance, one needs to be aware of the regulations, interpret their impact on the quality system and operations, and if necessary, then change, adapt and improve these. This process is a continuous improvement process cycle in Pharmaceutical Industries (1).