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Points of the revised GMP Ministerial Ordinance with reference to its expected roles in prevention of recently arising pharmaceutical quality issues
2022 Volume 71 Issue 2 Pages 147-155
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2022 Volume 71 Issue 2 Pages 147-155
Recently, product recalls have been repeatedly reported owing to quality issues caused by critical failures of GMP control and organizational fraud. Preventing recurrence of quality issues to regain public trust in the pharmaceutical industry is a top-priority duty of marketing authorization holders, manufacturers, and regulatory authorities.
Meanwhile, the revised Act on Securing Quality, Efficacy, and Safety of Pharmaceuticals, Medical Devices, Regenerative, and Cellular Therapy Products (PMD Act) was enforced on August 1, 2021, by which the establishment of a legal compliance system was stipulated as a duty for pharmaceutical industries.
On the same day, the revised GMP Ministerial Ordinance (GMP-MO) was also enforced to introduce the Pharmaceutical Quality System in manufacturing sites, aiming for the international harmonization of GMP standards as well as prevention of the recurrence of quality issues.
In this paper, I outline the expected roles of the revised GMP-MO in the prevention of quality issues, focusing on its revisions and the background of the revisions, with reference to relevant notifications.
