Continent-Specific Global GMP and regulatory compliance Updates for API & Pharmaceutical Manufacturers
Introduction
Regulatory authorities worldwide are strengthening expectations around GMP robustness, quality maturity, contamination control, data integrity, and AI governance in pharmaceutical manufacturing. Global GMP and regulatory compliance updates across Africa, North America, Europe, Asia, and Oceania are increasingly aligned with ICH, PIC/S, WHO, and regional frameworks, emphasizing lifecycle control, digital governance, and inspection readiness.
Masuu Global Solutions helps pharmaceutical organizations translate evolving regulations into practical, inspection-ready, and globally aligned compliance strategies. For guidance or inquiries, reach us at drramesh@masuuglobal.com.
Africa – SAHPRA (South Africa)
API GMP Alignment with ICH Q7 (Effective October 2025)
SAHPRA has adopted an ICH Q7–aligned GMP framework for APIs, strengthening requirements for quality systems, data integrity, change control, impurity/stability management, and supplier oversight. Finished product guidance emphasizes container-closure qualification, validated processes, and robust stability programs.
References & Guidance:
North America – United States & Mexico
United States (FDA & USP)
The FDA emphasizes quality maturity, aseptic processing, computerized system governance, and data integrity. USP <665> and <1665> (effective May 2026) introduce enforceable requirements for plastic components and single-use systems in biopharmaceutical manufacturing.
Mexico (COFEPRIS)
COFEPRIS aligns with PIC/S and WHO GMP, recognizes select international GMP certifications, digitizes regulatory processes, and strengthens regulatory science and AI governance.
References & Guidance:
- 21 CFR 210 and 21 CFR 211
- FDA Aseptic Processing Guidance
- USP–NF <665>/<1665>
- COFEPRIS GMP Guidelines
- WHO GMP
- PIC/S Framework
Europe – EMA & European Commission
The EU is consulting on revised Chapter 1 of EudraLex Volume 4, reinforcing Quality Risk Management (ICH Q9 R1) and Knowledge Management (ICH Q10). EMA draft Annex 22 introduces the first EU GMP framework for AI/ML systems, focusing on intended use, validation, data governance, and human oversight.
References & Guidance:
Asia – India, China, Japan & ASEAN
India – CDSCO & Revised Schedule M
Focuses on facility design, contamination control, quality systems, validation, stability programs, and data integrity, aligning closer to WHO GMP and PIC/S.
China – NMPA GMP & MAH System
Enhances GMP enforcement under the Marketing Authorization Holder system, reinforcing lifecycle accountability, supplier oversight, and risk-based inspections.
Japan – PMDA/MHLW & ICH Leadership
Maintains strong ICH alignment with emphasis on Pharmaceutical Quality Systems, post-approval changes, and global harmonization.
ASEAN – Regional GMP Convergence
Advances harmonization through ASEAN Common Technical Dossier (ACTD) and alignment with PIC/S GMP standards for better mutual recognition.
References & Guidance:
- CDSCO Revised Schedule M
- WHO GMP
- PIC/S GMP Guide
- ICH Q7, Q9, Q10
- NMPA GMP Regulations
- PMDA/MHLW GMP Ordinance
- ASEAN ACTD & GMP Framework
Oceania – Australia (TGA)
From 1 September 2025, TGA will implement PIC/S GMP Guide PE009-17, focusing on Annex 1 — Manufacture of Sterile Medicinal Products with phased compliance. PIC/S GMP is legally adopted as Australia’s manufacturing principles.
References & Guidance:
How Masuu Global Supports Global Compliance
Masuu Global Solutions supports pharmaceutical companies in achieving global GMP and regulatory compliance through risk-based, inspection-ready strategies aligned with international standards, including:
- ICH, PIC/S, FDA, EMA, SAHPRA, CDSCO, NMPA gap assessments
- AI and computerized system compliance (CSA, data integrity, audit trails)
- SOP, CCS, and global quality system alignment
- Validation, stability, and contamination control strategies
- Mock inspections & regulatory response planning (FDA 483, EU GMP, SAHPRA, TGA, CDSCO)
Conclusion
Early alignment with continent-specific regulatory expectations strengthens inspection outcomes, improves quality maturity, and ensures sustainable global market access. Masuu Global is committed to supporting pharmaceutical manufacturers with globally aligned, practical compliance solutions.