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GMP Around the World: How the US, EU, Japan, China, Brazil, EAEU, and WHO Compare

Explore how GMP regulations differ across the US, EU, Japan, China, Brazil, EAEU, and WHO. This global comparison highlights key similarities, differences, and best practices to help companies stay compliant in an interconnected pharmaceutical market.

In the pharmaceutical industry, Good Manufacturing Practice (GMP) is the common language of quality — but each region speaks it with its own accent. While the goal is always the same — safe, effective, high-quality medicines — the legal texts, inspection processes, and certification requirements vary widely. These differences can shape everything from facility layouts to batch release paperwork, and understanding them early can save enormous time, money, and frustration.

This document aims to provide a comprehensive comparison of GMP frameworks across different regions and the World Health Organization (WHO). It highlights the differences in legal texts, inspection processes, and certification requirements, which can impact various aspects of pharmaceutical manufacturing.

This comparison looks at six of the world’s major GMP frameworks — plus the World Health Organization (WHO), whose guidelines serve as the backbone for many countries without fully developed regulatory systems. (All references current as of August 2025.)

📊 GMP Side-by-Side Comparison

The table below summarizes key differences in GMP frameworks across major jurisdictions and the WHO, highlighting the legal basis, inspection practices, and unique requirements.

  
    GMP Side‑by‑Side Comparison
    
        Region / Jurisdiction
        Primary Regulator
        Core Legal Basis (Drugs)
        Inspection / Certification
        Key Features & Differences
      

    
        United States
        FDA
        21 CFR Parts 210 & 211 (plus 212, 225, 226)
        FDA risk‑based inspections
        ICH‑aligned principles; no QP role; CFR format
      

        European Union
        EMA + National Agencies
        EudraLex Vol 4 – EU GMP Guidelines (Directive 2001/83/EC)
        GMP certificate after inspection; QP certifies each batch
        QP required; PIC/S‑based; some MRAs
      

        Japan
        MHLW / PMDA
        GMP Ministerial Ordinance MO 16/1999 (drugs), MO 179/2004 (APIs)
        PMDA/MHLW inspect foreign & domestic sites
        Explicit ICH alignment; MAH responsible
      

        China
        NMPA
        GMP for Drugs (2010) + 2020 Provisions for Drug Manufacturing; 2025 Draft GMP for Sterile Products
        NMPA certification before production; sterile draft adds CCS, cleanroom classes, isolators/RABS
        Lifecycle QRM emphasis; stronger MAH/CMO oversight; sterile GMP aligning with EU Annex 1 concepts
      

        Russia / EAEU
        EAEU + National Ministries (e.g., Minpromtorg, SID&GP)
        EAEU GMP Rules – EEC Council Decision No. 77 (2016)
        GMP conformity assessment; internal recognition evolving
        EU‑modeled GMP; region‑wide registration framework
      

        Brazil (ANVISA)
        ANVISA
        RDC 658/2022 (drugs); RDC 665/2022 (devices); RDC 850/2024 (MDSAP = 4‑yr validity)
        Drug GMP certificates; device GMP validity extends to 4 years for MDSAP sites
        PIC/S‑aligned; strong overseas inspections; streamlined device certification under MDSAP
      

        World Health Organization (WHO)
        WHO Prequalification Team (PQT)
        TRS 986 Annex 2 (2014) core model; TRS 1060 (2025) updates (excipients GMP, nitrosamines, bioanalytical validation, etc.)
        WHO prequalification inspections, often joint with NRAs
        Global model adopted by many markets; essential for UN procurement
      

  

Key observations — and why they matter

1. Batch Release Authority:

EU, Brazil, EAEU: A Qualified Person (QP) must personally certify each batch before release.
US, Japan, China: Batch release is handled by the Quality Assurance (QA) or Marketing Authorisation Holder (MAH) responsible person.
WHO GMP: The World Health Organization (WHO) GMP does not require a Qualified Person (QP) for batch release. However, many countries that adopt WHO GMP mimic the EU-style oversight, which includes having a QP or a similar role to ensure compliance and maintain the quality of medicines. Examples of such countries include Brazil, Russia/EAEU, and China.

2. Certification Practices:

EU, EAEU, Brazil, China, Japan: issue formal GMP certifications;
US: compliance via inspection record (no formal certificate).
WHO: Issues prequalification certificates for UN (United Nations) procurement; joint inspections with NRAs (National Regulatory Authorities).

3. Mutual Recognition Agreements (MRAs)

EU ↔ US, Japan: Some reliance agreements.
EAEU: Internal mutual recognition.
Brazil, China: Prefer local inspections.
WHO: Not an MRA body, but globally referenced.

4. Risk Management & Lifecycle Approach

EU, Japan, Brazil, China (post-2010): Embed ICH Q9/Q10 into law.
US: Implements Q9/Q10 via guidance.
WHO: Promotes lifecycle QRM globally, especially for low- and middle-income countries.

WHO as a reference for emerging markets

For countries without their own robust GMP regulations, WHO GMP serves as the default framework.
National regulatory authorities may adopt WHO GMP wholesale or use it as a foundation, modifying it for local context. This approach:

Provides a harmonized standard for global supply chains
Enables smaller markets to participate in international trade
Supports consistent quality for medicines procured by UN agencies and NGOs (Non-Governmental Organization)

Takeaway

A single product may have to meet seven different GMP interpretations to reach global patients. The smartest approach is to design one strong, risk-based quality system aligned with internationally recognized standards — then adapt the finer details for each jurisdiction.

Frameworks like ISPE GAMP 5, ISPE Baseline Guides, and WHO GMP help build that universal foundation, so your quality system speaks every regulator’s language from day one.

Carmenchu Mungcal 8/5/25 Carmenchu Mungcal 8/5/25

Risk-Based Approach in Computerized System Validation: Smarter Compliance for a Modern Pharma Landscape

In today’s pharmaceutical landscape, digital systems and AI-enabled technologies are no longer emerging trends — they’re foundational to how modern pharma operates. As these tools become more embedded in GxP environments, regulatory expectations are shifting. Regulators aren’t asking for stacks of documentation — they’re asking for logic, traceability, and critical thinking.

That’s where a risk-based approach to Computerized System Validation (CSV) becomes essential. Rather than applying the same level of scrutiny to every system, this approach tailors validation activities based on the system’s potential impact on product quality, patient safety, and data integrity.

🔍 Why Risk-Based Validation Matters Today

The ISPE GAMP® 5 Second Edition reinforces the importance of risk-based thinking, particularly in the context of modern software development, cloud platforms, and AI/ML systems. It supports iterative and incremental validation models, promotes collaboration with suppliers, and encourages the use of automation and digital tools to enhance control and efficiency.

The more recent GAMP® Guide: Artificial Intelligence builds on this by offering practical guidance for validating AI-enabled systems — where traditional IQ/OQ/PQ methods may no longer apply. Instead, it emphasizes intended use, system transparency, and SME-driven decision-making to ensure systems are fit for purpose.

📚 What a Risk-Based CSV Strategy Looks Like

At its core, a risk-based validation strategy asks:

“What could go wrong here, and how critical is that risk?”

By evaluating a system’s criticality, complexity, and intended use, validation teams can focus efforts where they matter most. This principle — central to GAMP® 5 — is now further reinforced in the GAMP® AI guidance.

For example, a GMP-critical laboratory system used in batch release decisions demands rigorous testing and traceability. In contrast, a back-office scheduling tool presents little to no risk to product quality and may require minimal documentation.

✅ Benefits of a Risk-Based Approach

🎯 Focused testing for high-risk features
📉 Reduced documentation burden for non-critical systems
⚡ Accelerated deployment of digital and AI-enabled platforms
🔁 Built-in flexibility for continual improvement
📚 Alignment with FDA, EMA, GAMP® 5, and GAMP® AI guidance

🧭 Evolving with Technology — Including AI and SaaS

As pharma increasingly adopts AI-powered platforms and SaaS (Software as a Service) tools, validation strategies must adapt. SaaS platforms — cloud-hosted applications accessed via the internet — offer scalability, automatic updates, and remote accessibility, but they also introduce unique validation challenges around data integrity, access control, and shared responsibility.

The GAMP® AI Guide recognizes that not all systems can or should be validated with traditional methods. Instead, it emphasizes:

Thoughtful risk assessments
Clearly defined intended use
SME-led critical thinking
Lifecycle-based, phase-appropriate validation strategies

Even for teams still gaining experience with these technologies, the core principles remain:

➡ Validate what matters
➡ Understand what’s in your control
➡ Use evidence proportionate to risk

❗ Common Misconceptions

One frequent misconception is that validation equals paperwork. But effective validation is not about the volume of documentation — it’s about demonstrating control, clarity, and good decision-making.

A sound validation strategy includes:

Understanding system risk and regulatory impact
Documenting decisions with transparency
Using evidence that aligns with the system’s role and complexity

That’s not just compliant — it’s efficient and sustainable.

🚀 Final Thoughts

Risk-based validation isn’t a shortcut. It’s a practical, scalable way to ensure compliance while enabling innovation in a rapidly evolving digital environment.

Whether you’re maintaining legacy systems, deploying cloud tools, or integrating AI, the guiding principle remains:

👉 Let risk determine the depth of validation, and let compliance support — not hinder — innovation.

🧩 About the Author

This article was written by the Founder of Adris Pharma Services, with a passion for helping pharmaceutical teams apply practical, risk-based thinking to real-world validation and compliance challenges.
For more insights, explore other topics in the Insights section of this site.

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