GMP
Regulatory framework for pharmaceutical manufacturing quality control
ISO 27701
International standard for privacy information management systems
Quick Verdict
GMP ensures manufacturing quality in pharma and food via preventive controls and validation, while ISO 27701 certifies privacy governance for PII handling across industries. Companies adopt GMP for regulatory compliance and ISO 27701 for auditable privacy accountability.
GMP
Good Manufacturing Practices (GMP)
Key Features
- Independent quality unit batch release authority
- Validated processes and equipment qualification (IQ/OQ/PQ)
- Quality Risk Management (QRM) proportionality principles
- ALCOA+ data integrity and documentation controls
- Continual improvement via CAPA and audits
ISO 27701
ISO/IEC 27701:2025 Privacy Information Management
Key Features
- PIMS framework extending ISO 27001 for privacy
- Separate controls for PII controllers and processors
- Risk-based assessments and DPIAs required
- GDPR and regulatory mappings in annexes
- Auditable evidence for data subject rights
Detailed Analysis
A comprehensive look at the specific requirements, scope, and impact of each standard.
GMP Details
What It Is
Good Manufacturing Practices (GMP), including FDA 21 CFR Parts 210/211 and EU EudraLex Volume 4, is a regulatory framework establishing minimum standards for manufacturing controls. Its primary purpose is ensuring products like pharmaceuticals are consistently produced to quality specifications, preventing contamination, mix-ups, and variability through preventive, risk-based approaches like Quality Risk Management (QRM).
Key Components
- Core pillars: 5 Ps (People, Premises, Processes, Procedures, Products)
- Pharmaceutical Quality System (PQS) with CAPA, change control, audits
- Documentation (SOPs, batch records), validation (IQ/OQ/PQ), data integrity (ALCOA+)
- Enforced via inspections; no central certification but compliance demonstrated through audits
Why Organizations Use It
Mandated for market access in pharma/biologics; reduces recalls, liability; enhances supply reliability and efficiency. Builds patient trust, supports global harmonization (ICH Q10, PIC/S).
Implementation Overview
Phased: gap analysis, Validation Master Plan, training, qualification, audits. Applies to manufacturers globally; high complexity for facilities/equipment upgrades, ongoing for all sizes.
ISO 27701 Details
What It Is
ISO/IEC 27701:2025 is the international standard specifying requirements and guidance for establishing, implementing, maintaining, and improving a Privacy Information Management System (PIMS). It extends ISO/IEC 27001 with privacy-specific controls for managing personally identifiable information (PII) lifecycle, using a risk-based PDCA (Plan-Do-Check-Act) approach.
Key Components
- Clauses 4–10 for management system structure.
- **Annex AControls for PII controllers (e.g., consent, data subject rights).
- **Annex BControls for PII processors (e.g., contracts, sub-processors).
- Mappings to GDPR, ISO 27002; built on ISO security standards.
- Certification via accredited bodies with 3-year cycle.
Why Organizations Use It
- Demonstrates accountability to regulators like GDPR.
- Mitigates privacy risks, reduces fines, enhances trust.
- Competitive edge in procurement, supply chains.
- Harmonizes multi-jurisdictional compliance.
Implementation Overview
- Phased: discover/scope, design/plan, implement/operate, validate/improve.
- Involves PII inventory, DPIAs, training, audits.
- Applies to all sizes/industries handling PII; integrates with ISMS.
Key Differences
| Aspect | GMP | ISO 27701 |
|---|---|---|
| Scope | Manufacturing controls for product quality/safety | Privacy management system for PII lifecycle |
| Industry | Pharma, biologics, food, cosmetics globally | All sectors handling PII worldwide |
| Nature | Regulatory requirements, legally enforceable | Voluntary certification standard |
| Testing | Process validation, equipment qualification, audits | Internal audits, management reviews, certification |
| Penalties | Recalls, warning letters, fines, shutdowns | Loss of certification, no legal penalties |
Scope
Industry
Nature
Testing
Penalties
Frequently Asked Questions
Common questions about GMP and ISO 27701
GMP FAQ
ISO 27701 FAQ
You Might also be Interested in These Articles...
NIST 800-53 Private Sector ROI Reality Check: Isolating Control Family Impacts on 2024 Breach Costs
Discover NIST 800-53 ROI in private sector: control families like RA, SI, SR reduce median breach costs from $100K to under $50K. Get benchmarks to prioritize i
NIST CSF 2.0 Govern Function Deep Dive: Building Executive Cybersecurity Governance from Scratch
Step-by-step blueprint for NIST CSF 2.0 Govern function: templates, RACI matrices, metrics to elevate cybersecurity governance to boardroom level. Reduce breach
The Reasons Why NIS2 is Fundamental for Cyber Resilience in Europe
Uncover why NIS2 transcends compliance burdens, delivering real cyber resilience value through enforced measurements and activities. Explore insights via our pa
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
PMBOK vs IFS Food
Compare PMBOK vs IFS Food: Unlock key differences in project governance & food safety standards. Tailor PMBOK principles for IFS compliance—boost efficiency, cut risks now!
FISMA vs ISO 55001
Compare FISMA vs ISO 55001: Federal cybersecurity law meets asset mgmt standard. Discover compliance diffs, risks, strategies & implementation for resilient ops. Dive in!
SOC 2 vs TOGAF
Compare SOC 2 vs TOGAF: Key differences in compliance, security controls, and enterprise architecture. Discover implementation strategies, benefits, and the best fit for your org. (152 characters)