What does Japan's GMP ordinance require for personnel training?

The training duty sits in a Ministerial Ordinance made under Japan's main pharmaceutical statute. The Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (the PMD Act, Act No. 145 of 1960) provides that marketing approval is not to be granted where manufacturing control or quality control at the manufacturing site does not conform to the standard set by Ministry of Health, Labour and Welfare (MHLW) ordinance (Article 14(2)(iv)). That standard is the Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Drugs and Quasi-drugs (MHLW Ordinance No. 179 of 2004), commonly called the GMP ordinance (GMP shōrei). Its Article 1 says it sets the standard referred to in Article 14(2)(iv) (GMP ordinance, e-Gov).

For international readers, Japanese pharmaceutical regulation works in layers. The Act, passed by the Diet, sets licenses, approvals and enforcement powers. A Cabinet Order (seirei) fills in details such as inspection intervals. Ministerial Ordinances (shōrei) set binding technical standards, and GMP is one of them. MHLW then issues explanatory notices (tsūchi) and administrative notices (jimu renraku) that explain how inspectors read the ordinance. Notices are not legislation, but GMP inspectors apply them, so a training system should follow them.

The ordinance binds drug and quasi-drug manufacturers directly and binds marketing authorization holders indirectly. Article 3(2) requires manufacturers, including foreign manufacturers, to carry out manufacturing control and quality control under Chapter 2 (drugs) or Chapter 3 (quasi-drugs). Article 3(1) requires the marketing authorization holder to have its manufacturers do so.

Japan separates two licenses that many other systems combine. A manufacturing license (Article 13 of the PMD Act) is granted per manufacturing site and covers making the product. A marketing authorization holder (MAH) holds a marketing license under Article 12 and places the product on the market. The MAH must meet the Good Quality Practice (GQP) ordinance, which governs how it oversees its manufacturers and releases product to market (PMD Act, e-Gov). Foreign sites that make drugs for Japan need accreditation (Article 13-3) rather than a license.

Inside each site, Article 4 requires a manufacturing department and a quality department under the supervision of the manufacturing supervisor (seizō kanrisha), with the quality department independent of manufacturing. Since the 2021 revision, the quality department must contain a unit responsible for quality assurance and a unit responsible for testing. The training reporting line in Article 19 runs to that quality assurance unit and to the manufacturing supervisor.

Article 19 requires manufacturers to have a person designated in advance, following the written procedures, carry out four tasks. In PMDA's tentative translation, the manufacturer must have that person:

1. "for personnel that are engaged in production/quality related activities, to systematically implement necessary education/training on production control and quality management";
2. "to report implementation of the education/training, in writing to the quality assurance section and the manufacturing supervisor";
3. "to document and retain implementation records of the education/training"; and
4. "to assess practical effectiveness of the education/training regularly, to improve as necessary, and to document and retain records thereof".

Source: PMDA tentative translation of the GMP ordinance. The Japanese text of item 4 reads "kyōiku kunren no jikkōsei o teikiteki ni hyōka shi", literally to periodically evaluate the effectiveness of the education and training. Article 8(1)(xv) separately requires a written procedure for education and training at each site, so the training system itself must be documented, not just delivered.

Other articles create training triggers. Article 14(1)(iv) requires staff training and document revision when an approved change is implemented, and Article 3-3(iii) requires the quality policy and quality objectives to be made known to every organization and person involved in the pharmaceutical quality system at the site. Training therefore has to respond to change control, not only follow an annual calendar.

The MHLW notice issued with the 2021 revision says training must consist of knowledge education plus practical training in skills and techniques, matched to each person's work. Section 27 of the notice, on Article 19, lists the minimum content (MHLW notice of April 28, 2021, hosted by PMDA):

• an introduction to GMP, including the related laws and regulations;
• an introduction to hygiene control;
• an overview of the pharmaceutical quality system, including the company's quality policy, the site's quality objectives and the management structure; and
• training on each person's actual work, including practical training in skills and techniques.

The notice also fills in the rest of Article 19. The trainee population is anyone doing production or quality related work who could affect product quality, expressly including staff who clean, maintain, sterilize or service premises, equipment and instruments. "Planned" means delivered under a training program set by the person responsible for training, and that person should be someone who knows the training content well, with duties and authority written into the site's organization documents under Article 6(4).

The written training report must show the date the report was prepared and approved, its control number and the names of those responsible, the date or period of training, the content delivered, the names and affiliations of trainees, and the name and affiliation of the training lead. A report that contains this information can double as the training record. On effectiveness, the notice asks for a system that periodically evaluates, for each trained employee, organization or department, whether they can perform their work properly given the knowledge, skills and techniques required, and whether training frequency and content are appropriate. Revising or expanding the training program is its example of an improvement.

Sterile and biological manufacturing sites must add specific training on top of Article 19. Article 25 applies to sterile drugs and requires training in hygiene control, microbiology and other necessary topics for staff in manufacturing or testing, and training in measures to prevent microbial contamination for staff working in clean and aseptic areas. Article 29 applies to biological drugs and requires training in microbiology, medicine and veterinary science for manufacturing and testing staff, and contamination prevention training for staff in aseptic areas and areas handling pathogenic microorganisms. Each article applies "in addition to" the earlier training articles.

Quasi-drug manufacturers follow Article 47, which mirrors the first three items of Article 19 but reports to the responsible engineer (sekinin gijutsusha) rather than the quality assurance unit. The text of Article 47 does not contain the effectiveness evaluation item, and Article 53 adds sterile quasi-drug training.

MHLW Ordinance No. 90 of 2021, promulgated April 28, 2021 and in force from August 1, 2021, rebuilt the GMP ordinance around a pharmaceutical quality system and added the effectiveness duty to Article 19. The MHLW notice says the revision followed changes to the PIC/S GMP guidelines since Japan joined and aimed at greater international consistency. Comparing the ordinance text before and after the revision on e-Gov shows the following changes relevant to training.

Article 6(3), which requires manufacturers to secure sufficient personnel able to carry out production and quality work, was already in the pre-2021 text, so it is not new. What the 2021 notice adds is how competence is judged: section 9 says the ability of responsible persons should be assessed in light of their work, practical experience and training history under Articles 19, 25 and 29, and assured under the site's pharmaceutical quality system. Training records therefore support staffing decisions as well as proving attendance.

Training records must be kept for five years from the date they are created. Article 20(1)(iii) sets five years for GMP documents and records, extended to the product's shelf life plus one year where that is longer, but it expressly excludes training records from the extension. For active pharmaceutical ingredient (API) sites, Article 22 sets retest date or shelf life based periods for most records but again fixes five years for training records.

Under the 2021 notice, the retained training records are the Article 19(ii) training report and the records under items (iii) and (iv), which means effectiveness evaluations and resulting improvements must be retained too. Because Article 20(2) now requires controls on the completeness, accuracy and consistency of records, electronic training records fall inside the site's data integrity controls. The notice also lists training activities among the items to cover in periodic self inspection under Article 18.

Compliance is checked by GMP compliance inspections at marketing approval and at least every five years after that. Article 14(6) of the PMD Act requires the applicant or approval holder to undergo a document or on-site inspection when seeking approval and after each period set by Cabinet Order, not shorter than three years. Article 21 of the Order for Enforcement sets that period at five years (Order for Enforcement of the PMD Act, e-Gov).

Inspection is split between agencies. According to PMDA, it inspects domestic sites for products such as new (non-generic) drugs, biological products and radiopharmaceuticals, and all foreign sites for products imported into Japan, while prefectural inspectorates cover other domestic sites. PMDA has inspection authority only; MHLW takes administrative action on PMDA's findings, and prefectures can both inspect and act (PMDA, legal authorities of GMP inspections).

The PMD Act gives the Minister power to order a marketing authorization holder to improve manufacturing control or quality control methods at the manufacturing site that do not conform to the GMP standard, or to suspend business until they are improved (Article 72(2)), and to revoke licenses or suspend business for violations of pharmaceutical laws (Article 75).

No, not as at September 2026. The Act Partially Amending the PMD Act and Other Acts (Act No. 37 of 2025) was promulgated on May 21, 2025 and is coming into force in stages, with dates recorded on e-Gov from May 21, 2025 through May 20, 2028. Two consequential ordinances amend the GMP ordinance: MHLW Ordinance No. 117 of 2025, in force from May 1, 2026, and MHLW Ordinance No. 110 of 2026, due to take effect on May 20, 2027.

Comparing the GMP ordinance versions on e-Gov, both amendments change only the PMD Act paragraph numbers cross referenced in Article 3-2 (compliance with approved matters). Articles 19, 25, 29 and 47 are unchanged in the version in force and in the version due in May 2027. Training teams should still watch for revised notices as the remaining stages of the amending Act take effect.

A practical approach is to map each article to a measurable learning outcome and the evidence an inspector would expect to see. The table below is illustrative, not MHLW or PMDA guidance. Adapt it to the site's own procedures and training matrix.

Building the matrix from approved standard operating procedures keeps training aligned when procedures change, which is the method described in how to turn SOPs into training. For the effectiveness row, see how to evidence training effectiveness to a regulator.

Marketing authorization holders and medical device makers have their own training articles in separate ordinances. Article 14 of the GQP ordinance requires a drug MAH to have a designated person prepare a training plan for people doing quality control work, deliver the training systematically, record it, and report to the quality assurance responsible person (hinshitsu hoshō sekininsha) when someone else runs it (GQP ordinance, e-Gov). Article 10 of the same ordinance requires the MAH to confirm periodically that its manufacturers conduct manufacturing and quality control properly, which can reasonably extend to checking their training arrangements.

Marketing authorization holders for medical devices and in vitro diagnostics follow the QMS ordinance (MHLW Ordinance No. 169 of 2004). Its Article 23 (competence, awareness and training) requires them to define the competence needed by people whose work affects product quality, provide training or other action to achieve it, evaluate the effectiveness of that action, and keep records of education, training, skills and experience (QMS ordinance, e-Gov). Readers working across standards can compare ISO 9001 competence requirements.

Knowledge Foundry models Articles 3-3, 14, 19, 20, 25 and 29 of the GMP ordinance and the relevant sections of the MHLW notice as obligations, links each to the site's own procedures and roles, and defines learning outcomes and assessment points before training content is written. When a procedure changes or MHLW revises the ordinance or its notices, the affected roles and assessments are identified from the framework, giving the quality assurance unit a traceable record for inspection.