What It Is

Good Manufacturing Practice (GMP), including cGMP under FDA 21 CFR Parts 210/211, EU EudraLex Volume 4, and WHO GMP, is a regulatory framework establishing minimum standards for manufacturing controls. It ensures products like pharmaceuticals and biologics are consistently produced to quality criteria, emphasizing preventive systems over end-testing alone, with a risk-based approach via Quality Risk Management (QRM).

Key Components

• Core pillars: 5 Ps (People, Premises, Processes, Procedures, Products)
• Quality Management System (PQS per ICH Q10), documentation, validation, personnel training, facility/equipment controls, supplier oversight, CAPA, audits
• No fixed control count; subparts/chapters cover organization to distribution
• Compliance via inspections, no central certification but site approvals

Why Organizations Use It

Mandated for market access in pharma/biologics; prevents recalls, contamination, liability; reduces costs via efficiency; builds regulator/patient trust; enables global supply chains through harmonization (ICH, PIC/S).

Implementation Overview

Phased: gap analysis, Validation Master Plan, SOPs, qualification (IQ/OQ/PQ), training, audits. Applies to manufacturers globally; high complexity for facilities/validation; ongoing via continual improvement.

What It Is

ISO/IEC 27018:2025 is a code of practice extending ISO 27001 and ISO 27002 specifically for protecting personally identifiable information (PII) processed by public cloud service providers acting as PII processors. It addresses cloud-specific privacy risks like multi-tenancy and cross-border data flows through risk-based controls integrated into an Information Security Management System (ISMS).

Key Components

• Approximately 25–30 privacy-specific controls mapped to ISO 27001 Annex A themes: Organizational, People, Physical, Technological
• Core principles: consent/choice, purpose limitation, data minimization, accuracy, transparency, accountability
• Assessed as part of ISO 27001 certification; no standalone certification

Why Organizations Use It

• Builds customer trust and accelerates procurement via audited transparency
• Supports regulatory compliance (e.g., GDPR Article 28 processor duties)
• Mitigates privacy risks in clouds, aids cyber insurance
• Provides competitive differentiation for CSPs

Implementation Overview

• Start with gap analysis on existing ISMS
• Update Statement of Applicability, policies, contracts
• Suitable for CSPs all sizes with ISO 27001 base
• Third-party audits during ISO 27001 cycles (annual surveillance)