GMP
Regulatory standards for pharmaceutical manufacturing quality control
ISO/IEC 42001:2023
International standard for AI management systems
Quick Verdict
GMP ensures manufacturing quality via preventive controls for pharma/food, while ISO/IEC 42001:2023 governs AI risks ethically across sectors. Companies adopt GMP for regulatory compliance and safety; ISO 42001 for trustworthy AI, innovation, and certification credibility.
GMP
Current Good Manufacturing Practice (cGMP)
Key Features
- Mandates preventive controls beyond final product testing
- Requires independent quality unit batch release authority
- Enforces comprehensive documentation and data integrity
- Applies risk-based Quality Risk Management principles
- Demands validated processes and equipment qualification
ISO/IEC 42001:2023
ISO/IEC 42001:2023 AI Management Systems
Key Features
- PDCA framework with HLS for ISO integration
- Mandatory AI Impact Assessments for high-risk AI
- 38 Annex A controls for AI-specific risks
- Full AI lifecycle management to decommissioning
- Role-based scoping for providers and users
Detailed Analysis
A comprehensive look at the specific requirements, scope, and impact of each standard.
GMP Details
What It Is
Good Manufacturing Practice (GMP), including cGMP under FDA 21 CFR Parts 210/211 and EU EudraLex Volume 4, is a regulatory framework establishing minimum standards for manufacturing controls. It ensures products like pharmaceuticals and biologics are consistently produced to quality specifications using preventive, risk-based approaches like Quality Risk Management (QRM).
Key Components
- **5 PsPeople, Premises, Processes, Procedures, Products.
- PQS elements: monitoring, CAPA, change control, management review.
- Documentation (SOPs, batch records), validation (IQ/OQ/PQ), data integrity (ALCOA++).
- Built on ICH Q9/Q10; enforced via inspections, no universal certification but compliance mandatory.
Why Organizations Use It
Mandated for market access; prevents recalls, contamination; reduces liability. Builds supply reliability, efficiency; enhances reputation via proven controls.
Implementation Overview
Phased: gap analysis, VMP, validation, training, audits. Applies to pharma/biologics manufacturers globally; requires ongoing inspections, no central certification.
ISO/IEC 42001:2023 Details
What It Is
ISO/IEC 42001:2023 is the world's first international standard for establishing, implementing, maintaining, and improving an Artificial Intelligence Management System (AIMS). It provides a PDCA-based framework to manage AI risks and opportunities responsibly across the full AI lifecycle, applicable to any organization regardless of size, sector, or AI role (developer, provider, user).
Key Components
- Clauses 4-10 cover context, leadership, planning, support, operation, evaluation, and improvement.
- Annex A with 38 AI-specific controls addressing data, transparency, integrity, and resiliency.
- Built on ISO High-Level Structure (HLS) for integration with ISO 9001/27001.
- Certification via accredited third-party audits, with 3-year validity and surveillance.
Why Organizations Use It
- Mitigates AI risks like bias, drift, and ethics; aligns with EU AI Act.
- Builds trust, enhances reputation, enables innovation.
- Delivers ROI via procurement advantages, insurance discounts, compliance efficiency.
Implementation Overview
- Phased gap analysis, AIIAs, training, audits.
- 6-12 months typical, faster with existing ISO systems.
- Universal applicability; tools like ISMS.online accelerate.
Key Differences
| Aspect | GMP | ISO/IEC 42001:2023 |
|---|---|---|
| Scope | Manufacturing controls for product quality/consistency | AI lifecycle governance, risks, ethics |
| Industry | Pharma, biologics, food, cosmetics globally | All sectors using/developing AI universally |
| Nature | Enforceable regulations/guidelines, inspections | Voluntary certification standard, audits |
| Testing | Process validation, equipment qualification, audits | AI impact assessments, monitoring, certifications |
| Penalties | Warning letters, recalls, fines, shutdowns | Loss of certification, reputational damage |
Scope
Industry
Nature
Testing
Penalties
Frequently Asked Questions
Common questions about GMP and ISO/IEC 42001:2023
GMP FAQ
ISO/IEC 42001:2023 FAQ
You Might also be Interested in These Articles...
Top 10 Reasons ISO 27701 is the Ultimate Privacy Boost for Your ISO 27001 ISMS in 2025
Extend ISO 27001 with ISO 27701 for ultimate privacy governance amid GDPR & AI regs. Discover top 10 advantages like integrated audits to future-proof your ISMS
Measuring NIST CSF 2.0 Success: KPIs, Dashboards, and Continuous Improvement Using Tiers & Profiles
Transform NIST CSF 2.0 into quantifiable success: Define board-ready KPIs for Functions, build Profile dashboards, track Tier progression. Prove ROI amid cyber
DORA Third-Party Risk Management: A Consultant’s Guide to Mapping Critical ICT Service Providers in 2026
Navigate DORA's complex third-party risk pillar. Step-by-step consultant guide to identify critical ICT providers, remediate Article 30 contracts, and build the
Run Maturity Assessments with GRADUM
Transform your compliance journey with our AI-powered assessment platform
Assess your organization's maturity across multiple standards and regulations including ISO 27001, DORA, NIS2, NIST, GDPR, and hundreds more. Get actionable insights and track your progress with collaborative, AI-powered evaluations.
Check out these other Gradum.io Standards Comparison Pages
DORA vs AS9120B
Compare DORA vs AS9120B: EU finance resilience act vs aerospace distributor QMS. Key differences, compliance strategies & implementation guide to excel in your sector. Dive in!
PRINCE2 vs ISA 95
PRINCE2 vs ISA 95: Project governance meets manufacturing integration. Compare PRINCE2's 7 principles, practices & processes with ISA-95's levels & models. Boost IT/OT efficiency now!
WELL vs REACH
Discover WELL vs REACH: WELL certifies healthy buildings with 10 concepts, preconditions & onsite tests; REACH regulates chemicals via registration, evaluation & restrictions. Compare now for ESG wins.