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