GMP
Regulatory framework for pharmaceutical manufacturing quality controls
ISO 27017
International code of practice for cloud security controls
Quick Verdict
GMP enforces manufacturing quality controls for pharma to prevent contamination and ensure patient safety, while ISO 27017 provides cloud-specific security guidance within ISO 27001 ISMS. Companies adopt GMP for regulatory compliance and market access; ISO 27017 for cloud risk management and procurement trust.
GMP
Good Manufacturing Practice (GMP)
ISO 27017
ISO/IEC 27017:2015 Code of practice for cloud services
Key Features
- Clarifies shared responsibilities between CSPs and CSCs
- Introduces seven cloud-specific CLD security controls
- Provides guidance on 37 ISO 27002 controls for cloud
- Ensures segregation in virtualized multi-tenant environments
- Integrates seamlessly into ISO 27001 certification audits
Detailed Analysis
A comprehensive look at the specific requirements, scope, and impact of each standard.
GMP Details
What It Is
Good Manufacturing Practice (GMP) is a regulatory framework of minimum enforceable standards for manufacturing pharmaceuticals, biologics, and related products. It ensures consistent production meeting quality criteria through preventive controls, not end-product testing. Scope spans materials to distribution; employs risk-based Quality Risk Management (QRM) per FDA 21 CFR Parts 210/211, EU EudraLex Volume 4, and WHO GMP.
Key Components
- **5 PsPeople, Premises, Processes, Procedures, Products
- Independent Quality Control Unit or Qualified Person (QP) oversight
- Validated processes/equipment (IQ/OQ/PQ), SOPs, batch records
- ICH Q9/Q10 foundations: QRM, Pharmaceutical Quality System (PQS)
- Compliance via inspections, audits; no universal certification
Why Organizations Use It
- Meets legal mandates, avoids recalls/fines/warning letters
- Mitigates contamination, mix-up risks
- Enables market access, supply reliability
- Drives efficiency, continual improvement via CAPA
- Builds patient safety, stakeholder trust
Implementation Overview
Phased: gap analysis, Validation Master Plan, QMS design, training, qualification, audits. Applies globally to manufacturers; scales by size/industry. Involves internal audits, regulatory inspections.
ISO 27017 Details
What It Is
ISO/IEC 27017:2015 is a code of practice for information security controls tailored to cloud services, extending ISO/IEC 27002. It provides cloud-specific implementation guidance within an ISO 27001 ISMS, focusing on shared responsibilities between cloud service providers (CSPs) and customers (CSCs). It uses a risk-based, control-oriented approach.
Key Components
- 37 adapted ISO 27002 controls with cloud guidance
- Seven additional CLD controls for multi-tenancy, VM hardening, asset lifecycle
- Built on ISO 27001/27002 frameworks
- No standalone certification; integrated into ISO 27001 audits
Why Organizations Use It
- Addresses cloud-specific risks like segregation and monitoring
- Supports regulatory compliance (e.g., GDPR alignment)
- Enhances procurement trust and competitive differentiation
- Improves risk management and stakeholder confidence
Implementation Overview
- Extend existing ISO 27001 ISMS via risk assessment and control mapping
- Key activities: document responsibilities, implement hardening, enable logging
- Suited for CSPs/CSCs globally, all sizes/industries
- Joint audits (9-12 months typical)
Key Differences
| Aspect | GMP | ISO 27017 |
|---|---|---|
| Scope | Manufacturing controls for pharmaceuticals, facilities, processes | Cloud-specific information security controls |
| Industry | Pharma, biologics, food, cosmetics globally | Cloud service providers and customers worldwide |
| Nature | Enforceable regulations with inspections | Voluntary code of practice for ISMS |
| Testing | Process validation, equipment qualification, audits | ISO 27001 audits with cloud control assessment |
| Penalties | Warning letters, recalls, fines, shutdowns | Loss of certification, no legal penalties |
Scope
Industry
Nature
Testing
Penalties
Frequently Asked Questions
Common questions about GMP and ISO 27017
GMP FAQ
ISO 27017 FAQ
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