ISO 27001
International standard for information security management systems
GMP
Global standards for manufacturing quality and patient safety.
Quick Verdict
ISO 27001 certifies voluntary information security management for all industries, while GMP enforces mandatory manufacturing quality controls for pharmaceuticals. Companies adopt ISO 27001 for cyber resilience and trust signaling; GMP ensures patient safety and regulatory market access.
ISO 27001
ISO/IEC 27001:2022 Information security management
Key Features
- Risk-based approach to ISMS implementation
- PDCA cycle for continual improvement
- 93 Annex A controls in four themes
- Technology-agnostic across all industries
- Internationally recognized certification standard
GMP
Good Manufacturing Practice (GMP)
Key Features
- Risk-based Quality Risk Management (QRM) principles
- Validated processes and equipment qualification (IQ/OQ/PQ)
- Independent quality unit oversight and batch release
- Comprehensive documentation with ALCOA+ data integrity
- Preventive controls for contamination and mix-ups
Detailed Analysis
A comprehensive look at the specific requirements, scope, and impact of each standard.
ISO 27001 Details
What It Is
ISO/IEC 27001:2022 is an international certification standard for establishing, implementing, maintaining, and improving an Information Security Management System (ISMS). It uses a risk-based approach to manage information assets' confidentiality, integrity, and availability across any organization.
Key Components
- **Clauses 4-10Mandatory requirements for context, leadership, planning, support, operation, evaluation, and improvement.
- **Annex A93 controls in four themes (Organizational:37, People:8, Physical:14, Technological:34).
- Built on PDCA cycle; voluntary certification via accredited auditors.
Why Organizations Use It
- Mitigates breaches, ensures compliance (e.g., GDPR alignment).
- Builds trust, wins bids, reduces insurance costs.
- Provides strategic resilience and competitive edge.
Implementation Overview
- Phased: initiation, risk assessment, controls, audits (6-18 months).
- Scalable for all sizes/industries; Stage 1/2 certification audits required.
GMP Details
What It Is
Good Manufacturing Practice (GMP) is a regulatory framework establishing minimum standards for manufacturing controls in pharmaceuticals, biologics, and related industries. It ensures products are consistently produced to quality criteria through preventive systems rather than end-testing alone, employing a risk-based approach via Quality Risk Management (QRM) and Pharmaceutical Quality Systems (PQS).
Key Components
- Core pillars: 5 Ps (People, Premises, Processes, Procedures, Products)
- Elements include personnel training, facility design, equipment validation, documentation, supplier controls, and continual improvement (CAPA, audits)
- Built on ICH Q9/Q10, FDA 21 CFR 210/211, EU EudraLex Volume 4, WHO GMP
- Compliance via inspections, no central certification but enforceable regionally
Why Organizations Use It
- Meets legal requirements, prevents recalls/liability
- Enhances supply reliability, market access
- Reduces contamination/mix-up risks
- Builds stakeholder trust, supports global trade
Implementation Overview
- Phased: gap analysis, validation, training, audits
- Applies to manufacturers globally, scales by size/risk
- Involves VMP, eQMS; regulator inspections required (approx. 178 words)
Key Differences
| Aspect | ISO 27001 | GMP |
|---|---|---|
| Scope | Information security management systems | Manufacturing processes and quality control |
| Industry | All industries, technology-agnostic | Pharmaceuticals, biologics, medical devices |
| Nature | Voluntary certification standard | Legally enforceable regulatory requirements |
| Testing | Risk assessments, internal/external audits | Process/equipment validation, batch testing |
| Penalties | Loss of certification, reputational damage | Fines, recalls, manufacturing shutdowns |
Scope
Industry
Nature
Testing
Penalties
Frequently Asked Questions
Common questions about ISO 27001 and GMP
ISO 27001 FAQ
GMP FAQ
You Might also be Interested in These Articles...
CMMC Level 2 Implementation Guide for Small DIB Contractors: First 5 Steps to C3PAO Certification with Infographic
Actionable CMMC Level 2 guide for small DIB contractors: 5-step roadmap to C3PAO certification with infographic on timelines, costs & POA&Ms. Achieve DoD compli
SEC Cybersecurity Rules Implementation Guide: Mastering Form 8-K Item 1.05 Materiality Determination and 4-Business-Day Reporting Workflow
Master SEC Form 8-K Item 1.05 compliance with step-by-step materiality assessment, incident workflows & Inline XBRL tagging. Beat the 4-business-day clock. Esse
PDPA Cross-Border Transfer Rules Decoded: Singapore, Thailand, and Taiwan Mechanisms Compared with Practical Implementation Templates
Decode PDPA cross-border transfers for Singapore, Thailand, Taiwan. Statutory excerpts, approved mechanisms, SCC templates. Harmonize with GDPR, navigate exempt
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
ISO 55001 vs ISO 50001
Compare ISO 55001 vs ISO 50001: Asset mgmt mastery meets energy efficiency. Key diffs, clauses, benefits & tips to pick the right std for your ops success!
ENERGY STAR vs ISO 45001
ENERGY STAR vs ISO 45001: Compare energy efficiency certification & OH&S management. Boost performance, cut costs/emissions, ensure safety—discover key differences now!
POPIA vs NIST 800-53
Unlock POPIA vs NIST 800-53: SA's GDPR-like privacy law (8 conditions, juristic persons) vs US security catalog (20 families, baselines). Bridge gaps for compliance. Align now!