GMP
Regulatory framework for consistent pharmaceutical manufacturing quality
NIST 800-171
U.S. standard protecting CUI in nonfederal systems.
Quick Verdict
GMP ensures manufacturing quality for pharma globally via preventive controls and audits, preventing contamination. NIST 800-171 protects CUI confidentiality in US defense contractors through cybersecurity requirements and assessments, enabling contract eligibility.
GMP
Current Good Manufacturing Practice (cGMP)
Key Features
- Mandates independent Quality Control Unit oversight
- Requires validated processes preventing testing reliance
- Integrates Quality Risk Management proportionality
- Enforces comprehensive documentation and traceability
- Implements 5 Ps preventive control framework
NIST 800-171
NIST SP 800-171: Protecting CUI in Nonfederal Systems
Key Features
- Protects CUI confidentiality in nonfederal systems
- 110 requirements across 14-17 control families
- SSP and POA&M for documentation and remediation
- Scoped enclave architecture for boundary control
- FedRAMP Moderate equivalence for cloud services
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, 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 final testing via risk-based Quality Risk Management (QRM) and Pharmaceutical Quality System (PQS).
Key Components
- **5 PsPeople, Premises, Processes, Procedures, Products
- Independent Quality Control Unit for approvals/rejections
- Validated processes, equipment qualification (IQ/OQ/PQ), documentation (SOPs, batch records)
- CAPA, change control, audits; built on ICH Q9/Q10
- Compliance via inspections, no central certification
Why Organizations Use It
Mandated for market access, it mitigates recalls, contamination risks, and liabilities. Provides supply reliability, efficiency gains, and trust from regulators/stakeholders.
Implementation Overview
Phased: gap analysis, Validation Master Plan, training, validation, audits. Applies to pharma/biologics manufacturers globally; enforced by FDA, EU QP, WHO inspections.
NIST 800-171 Details
What It Is
NIST SP 800-171 (Protecting Controlled Unclassified Information in Nonfederal Systems and Organizations) is a U.S. cybersecurity framework providing recommended security requirements for safeguarding CUI confidentiality in nonfederal systems. Tailored from NIST SP 800-53 Moderate baseline, it uses a control-based approach focused on nonfederal contractors handling federal data.
Key Components
- 17 families in Rev. 3 (e.g., Access Control, Audit, Supply Chain Risk Management) with ~97-110 requirements.
- Core artifacts: System Security Plan (SSP) and Plan of Action and Milestones (POA&M).
- Assessment via SP 800-171A (examine/interview/test).
- Built on FIPS 200 and SP 800-53; supports tailoring and FedRAMP equivalence.
Why Organizations Use It
- Mandatory via DFARS 252.204-7012 for DoD contractors.
- Enables contract eligibility, reduces breach risks, builds supply chain trust.
- Enhances resilience, competitive edge in federal procurement.
Implementation Overview
- Phased: scoping, gap analysis, SSP/POA&M, controls, monitoring.
- Applies to contractors globally; suits SMBs via enclaves.
- Self/third-party assessments; CMMC Level 2 alignment. (178 words)
Key Differences
| Aspect | GMP | NIST 800-171 |
|---|---|---|
| Scope | Manufacturing processes, facilities, quality controls | Cybersecurity for CUI in nonfederal systems |
| Industry | Pharma, biologics, food, cosmetics globally | Defense contractors, federal supply chains US |
| Nature | Regulatory quality standards, legally enforceable | Recommended security requirements, contract-mandated |
| Testing | Process validation, equipment qualification, audits | Examine/interview/test assessments, SSP/POA&M |
| Penalties | Recalls, warning letters, market bans | Contract ineligibility, SPRS score deductions |
Scope
Industry
Nature
Testing
Penalties
Frequently Asked Questions
Common questions about GMP and NIST 800-171
GMP FAQ
NIST 800-171 FAQ
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