PMDA GMP Inspection System (Japan) – Expectations for Domestic and Overseas Sites

This topic is part of the SG Systems Global regulatory & operations glossary.

Updated December 2025 • GMP, ICH Q7, ICH Q10, PQS, QRM, Data Integrity • Regulatory Affairs, QA, Operations, CMC, Global Supply

PMDA’s GMP inspection system is Japan’s framework for evaluating whether manufacturers of drugs and biologics meet Japanese Good Manufacturing Practice requirements. The Pharmaceuticals and Medical Devices Agency (PMDA) conducts document reviews and on-site inspections, while the Ministry of Health, Labour and Welfare (MHLW) ultimately grants, renews or revokes manufacturing/marketing approvals and GMP compliance status. For manufacturers supplying Japan—whether domestic or overseas—the PMDA inspection model is a reality check on their global quality story: it tests not just whether the site can produce good batches, but whether its pharmaceutical quality system, validation, data integrity and life-cycle controls meet a regulator that is quietly rigorous and strongly aligned with ICH.

“PMDA doesn’t just ask, ‘Is this product safe today?’ It asks, ‘Will this system still be in control in five years?’”

1) What the PMDA GMP Inspection System Actually Is

Japan’s GMP inspection system is a framework under which PMDA and MHLW verify that manufacturing sites supplying the Japanese market comply with Japanese GMP ordinances and ICH-aligned guidance. It encompasses document-based reviews and on-site inspections of facilities, utilities, equipment, processes, labs and quality systems. PMDA issues inspection reports and GMP compliance judgements that feed into the “manufacturing/marketing business” licensing decisions overseen by MHLW. For foreign sites, a PMDA GMP inspection is usually part of the marketing authorisation review or subsequent lifecycle oversight.

2) PMDA, MHLW and Prefectural Authorities – Who Does What

Japan’s regulatory landscape divides responsibilities. MHLW sets laws and ordinances and grants manufacturing/marketing authorisations. PMDA performs scientific review of marketing applications and conducts many GMP inspections, especially for high-risk products and foreign sites. Prefectural authorities (regional governments) perform GMP surveillance and licensing tasks for many domestic manufacturers. In practical terms, a manufacturer sees PMDA as the primary GMP interlocutor for products under national review, while local authorities handle routine inspections of smaller or lower-risk sites. All operate under a harmonised GMP framework that closely tracks ICH and PIC/S principles.

3) Scope – Which Products and Sites Are in Play

PMDA’s GMP inspections cover a broad range of modalities: small-molecule drugs, biologicals and vaccines, advanced therapies, blood products, radiopharmaceuticals, and certain investigational products. Inspections may focus on finished dose manufacturing, API production (especially for critical or complex APIs), contract testing labs and key outsourced activities. For marketing authorisations, PMDA looks at the specific “manufacturing/quality control sites” named in the dossier; any facility that materially affects product quality can be subject to inspection, including CMOs and important suppliers. Overseas sites are squarely in scope if they supply finished products or critical intermediates to Japan.

4) Types of PMDA GMP Inspections

Common inspection types include: pre-approval inspections (PAIs) linked to new drug applications, periodic/re-certification inspections for established products, and for-cause inspections triggered by quality defects, complaints, PV signals or information from other regulators. PAIs look closely at the consistency between the dossier (process description, control strategy, validation) and what PMDA observes on site. Routine inspections focus more on how well the PQS maintains control over time: handling of deviations, CAPA, changes, PQR/APR and CPV. For-cause inspections can be intensive and narrowly focused on known or suspected problems.

5) Link to ICH and Japanese GMP Ordinances

Japan is a founding ICH member, and PMDA inspections explicitly reflect ICH quality guidelines, especially Q7 (APIs), Q8 (pharmaceutical development), Q9 (risk management) and Q10 (PQS). Japanese GMP ordinances incorporate these principles and provide the legal backbone. That means a site “designed for EMA/FDA” will feel conceptually familiar under PMDA review—so long as the implementation is sound. Conversely, sites that rely on minimal, compliance-only systems often find that PMDA questions go deeper into lifecycle control and knowledge management than they are used to answering.

6) Pharmaceutical Quality System – PMDA’s View

PMDA expects a PQS that looks and behaves like an ICH Q10 system: management-led, risk-based, integrated across development, tech transfer and commercial operations. Inspectors look for evidence that change control, deviation management, root-cause analysis, CAPA, supplier management and knowledge management are cohesive and effective. “Paper PQS” that exists in SOPs but not in decision-making is a common weakness. PMDA pays close attention to management review, the use of metrics and how lessons learned are shared across products and sites—including global networks where Japanese supply relies on overseas plants.

7) Process Validation and Continued Process Verification (CPV)

PMDA expects validation to follow a lifecycle model: process design, process performance qualification (PPQ) and ongoing verification. That aligns with US and EU thinking and is increasingly operationalised through CPV programmes. In practice, PMDA inspectors look for coherent validation protocols, scientifically justified acceptance criteria, data-driven conclusions and real-time monitoring of critical process parameters and quality attributes. For biologics and complex products, process understanding and control are scrutinised especially hard. A “three batches and forget” approach will not withstand detailed questioning about variability, trending and long-term capability.

8) Data Integrity and Computerised Systems in PMDA Inspections

Like other major regulators, PMDA expects robust data integrity controls and validated computerised systems. That brings CSV, GAMP 5, MES/eBMR, LIMS and data historians into scope. Inspectors may review audit trails, user access matrices, configuration management, backup/restore processes and how interfaces between systems are controlled. Hybrid systems (paper + electronic) and “local” spreadsheets are particular stress points. PMDA tends not to publish as many DI case studies as FDA or MHRA, but the expectations are comparable when it comes to ALCOA+ and governance.

9) Quality Risk Management (QRM) and Design of Controls

Quality risk management is not optional in PMDA’s world. Inspectors expect to see formal risk assessments supporting control strategies, sampling plans, validation approaches and prioritisation of CAPAs. Tools may include FMEA, HACCP, fault-tree analysis or tailor-made matrices. What matters is that QRM is applied consistently, logically and updated as knowledge grows. Overly generic risk assessments, or those clearly written after the fact to justify existing practices, tend to attract critical questions. Sites that can show how QRM informed their facility, equipment and process design are generally more convincing than those that treat QRM as a documentation task.

10) Foreign Inspections – Supplying Japan from Overseas Sites

Overseas manufacturers supplying Japan may face PMDA GMP inspections regardless of their EU/FDA status. PMDA often coordinates foreign inspections closely with dossier reviews, especially for new products or high-risk modalities. In some cases, PMDA may rely partly on inspection reports from “stringent” regulators or joint inspection programmes, but it retains the right to inspect directly. For global companies, this means that “Japan readiness” is not limited to marketing application content; it also requires ensuring that foreign plants and CMOs can explain their systems to PMDA, often via interpreters, under time-pressured on-site reviews.

11) Interaction with International Networks and Reliance

PMDA participates in international regulatory networks and work-shares, including ICH, ICMRA and various bilateral/trilateral cooperation frameworks. While Japan has its own legal structure, PMDA may leverage information from EU, US, WHO and other inspections in its risk assessments and scheduling. Conversely, PMDA’s inspection outcomes can influence how other NRAs view the same sites. For multi-market manufacturers, this means that weaknesses exposed in one jurisdiction can cascade into questions elsewhere; a PMDA finding about PQS or DI is rarely a purely “Japan-only” issue from a global risk perspective.

12) Common PMDA Inspection Themes and Findings

Publicly available information and industry experience suggest recurring themes under PMDA inspection: incomplete integration of PQS concepts; inconsistent application of QRM; validation packages that lack lifecycle thinking; weak PQR/APR processes; investigation quality that stops at superficial causes; and patchy data-integrity controls, particularly in older or partially digitalised plants. Japan’s regulators also pay close attention to stability data, specification changes, impurity management and control of critical raw materials, reflecting the emphasis on patient safety and long-term product reliability in a relatively conservative market.

13) What Global MA Holders and Sponsors Should Expect

For originator and generic companies marketing in Japan, PMDA inspections are a whole-system evaluation of the supply chain. Sponsors must be able to explain site roles, tech-transfer decisions, control strategies, supplier qualification, and how global PQS components apply specifically to the Japanese product. Misalignments between the Japanese dossier and reality—different manufacturing routes, uncontrolled site changes, unreported CMO additions—are particularly problematic. Sponsors should anticipate that PMDA will test the integrity of their global change management and communication processes, not just the local site’s compliance.

14) Preparing for a PMDA GMP Inspection

Inspection readiness for PMDA looks a lot like readiness for EMA or FDA—with a few nuances. Practical steps include: reconciling the Japanese dossier with what is actually done on the shop floor and in the lab; ensuring that batch records, validation reports, MES/eBMR outputs and LIMS data tell a consistent story; training SMEs to answer questions clearly (with or without interpreters); and preparing a structured set of background documents (site master file, process descriptions, validation summaries, PQRs, key SOPs). Sites should also rehearse “data-rich” responses to classic topics: deviations, CAPA effectiveness, changes and risk assessments.

15) Using PMDA Outcomes for Continuous Improvement

PMDA observation letters and inspection reports are not only compliance events; they are structured feedback from a stringent regulator. Organisations that treat PMDA findings as catalysts for global improvement—updating global SOPs, strengthening PQS elements, harmonising validation standards—tend to see fewer surprises later from other NRAs. Those that treat findings as “a Japan thing” often rediscover the same weaknesses under EMA, FDA or WHO audits. Integrating PMDA feedback into global quality governance, training and digital roadmaps is one of the best returns a company can get from the effort invested in each inspection cycle.

16) FAQ

Q1. Does passing an EMA or FDA inspection guarantee a smooth PMDA inspection?
No. While alignment is strong, PMDA may emphasise different aspects (e.g. Japan-specific dossier commitments, certain PQS elements or regional risk considerations). A good EMA/FDA track record helps, but sites must still prepare specifically for Japanese expectations and the actual content of the Japanese MA.

Q2. Are PMDA GMP inspections mandatory for all foreign sites?
Not always, but they are common for higher-risk products, new NMEs and critical biologics. In some cases, PMDA may rely partly on inspection reports from other regulators, but it retains the right to inspect any site named in a Japanese application or deemed important for product quality.

Q3. How important is ICH Q10 during PMDA inspections?
Very. PMDA’s GMP framework explicitly reflects ICH Q10 principles. Inspectors expect PQS elements—management review, CAPA, change management, knowledge management—to be integrated and demonstrably effective, not just mentioned in SOPs.

Q4. Does PMDA focus heavily on data integrity and computerised systems?
Yes. As with other regulators, PMDA expects validated systems, robust audit trails, controlled access, and governance over hybrids and spreadsheets. MES, LIMS and other platforms are now central to inspection narratives, especially for complex and high-volume operations.

Q5. What is a practical first step to get “PMDA ready” at a global site?
Start with a reconciliation between the Japanese dossier and site reality, then perform a focused gap assessment around PQS, validation, QRM and data integrity. Use that gap analysis to prioritise remediation projects and to build an inspection readiness plan that includes documentation, SME coaching and mock interviews.

Related Reading
• ICH & PQS: ICH Q7 | ICH Q10 | Pharmaceutical Quality System (QMS) | PQR/APR
• Risk & Validation: Quality Risk Management (QRM) | Process Validation | Continued Process Verification (CPV)
• Data & Systems: Data Integrity | Audit Trail | CSV | GAMP 5 | MES | LIMS
• Investigations & Improvement: Deviation / NC | RCA | CAPA