Pharmaceutical quality system (PQS)

The management system that keeps product quality under control across the whole product lifecycle, as described in ICH Q10. In Japan it became a legal requirement for manufacturing sites when the GMP Ministerial Ordinance was revised in 2021 (in force August 1, 2021); the revision added one article on the pharmaceutical quality system and another on quality risk management. Japanese documents use the term for the framework that ties together deviation handling, CAPA, change control and product quality review. Expect Japanese partners and PMDA inspectors to ask how your PQS covers products made for Japan, including how the marketing authorization holder (MAH) hears about changes and quality problems.