On Establishing the Required Structure for a Modern QA Department [Part 1]

My name is Ryoichi Tanaka. 

Until the end of June 2024, I worked as a civil servant at the Kyoto Prefectural Government for about 18 years. For 11 of those years, I was in charge of pharmaceutical affairs administration, including GMP. From April 2018, for 2 years, I was seconded to the Ministry of Health, Labour and Welfare (MHLW), where I worked as a GMP Advising Officer in what is now the Compliance and Narcotics Division of the Pharmaceutical Safety and Environmental Health Bureau. There, I was engaged in the revision of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (PMD Act), the GMP Ministerial Order, and the QMS Ordinance for medical devices.

In many local governments, personnel are rotated through various departments, and Kyoto Prefecture is no exception. In April of 2024, I was transferred to a public health center, where I was responsible for licensing restaurants and other establishments, which meant I had to step away from GMP. I could anticipate that it could be several years, or even more than a decade, before I could work in GMP area again, I felt a strong desire to continue supporting companies through my expertise in GMP. I wanted to do work that would benefit the people of Japan and the world who use pharmaceuticals and medical devices. This led me to the decision to leave public service. I am now with CM Plus Corporation, where I provide consulting and seminars on GMP, QMS, and related topics. I hope this article will be of some help to you all.

1. What Has Changed with the Revised GMP Ministerial Order

Approximately 4 years have passed since the Ministerial Order on Standard for Manufacturing Control and Quality Control for Pharmaceuticals and Quasi-Pharmaceuticals, commonly known as the GMP Ministerial Order, was revised.

The background for this regulatory revision was to promote international harmonization, specifically to bridge the gaps with the PIC/S GMP standards. 

Furthermore, just before the revision, there were major cases of misconduct, and provisions concerning the establishment of a compliance system were added to the PMD Act, which is the parent law of the GMP Ministerial Order. These factors were also reflected in the revised ordinance.
While you may already be familiar with the revisions, I would like you to understand that the requirements listed in Table 1 have been specifically added.

I will now explain how the Quality Assurance (QA) department is involved in these additional requirements.。

1.1 Compliance with the Product Authorization Requirements (GMP Ministerial Order Article 3-2)

First, let's look at how the QA department is involved in ensuring ·the compliance with the Product Authorization Requirements. This is described in Article 5 of the GMP Ministerial Order, as shown in Table 2.

Although the ultimate responsibility for the compliance with the product authorization requirements lies with the responsible executive officer, in practice, the manufacturing supervisor is required to have the QA department manage it.

Even before the revision of the GMP Ministerial Order, manufacturers were required to conduct manufacturing and quality management in compliance with the product authorization requirements. However, the revised GMP Ministerial Order explicitly states that the QA department must proactively conduct management of manufacturing, etc., to ensure compliance with the product authorization requirements as part of its practical duties.

Therefore, the QA department must take the lead in devising measures to prevent discrepancies with the Marketing Authorization Certificate. It must constantly manage daily manufacturing records, deviations, and changes, etc., to ensure that any resulting differences do not affect the product authorization requirements. It must also, as necessary, confirm compliance with the product authorization requirements during site patrols and self-inspections.